<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03300388</url>
  </required_header>
  <id_info>
    <org_study_id>OBELEX</org_study_id>
    <nct_id>NCT03300388</nct_id>
  </id_info>
  <brief_title>Obesity, Inflammation and Aging: Effects of Physical Exercise and Omega-3 Fatty Acids.</brief_title>
  <acronym>OBELEX</acronym>
  <official_title>Dysfunction of Adipose Tissue in Obesity, Inflammation and Aging: Mechanisms and Effects of Physical Exercise and Omega-3 Fatty Acids.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clinica Universidad de Navarra, Universidad de Navarra</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministerio de Economía y Competitividad, Spain</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centro de Estudios, Investigación y Medicina del Deporte</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Instituto de Investigación Sanitaria de Navarra (IdiSNA)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Clinica Universidad de Navarra, Universidad de Navarra</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Dysfunction of adipose tissue in obesity, inflammation and aging: mechanisms and effects of&#xD;
      physical exercise and omega-3 fatty acids.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Obesity is associated with the development of metabolic diseases including type 2 diabetes&#xD;
      and immune disorders. Obesity also leads to reduced lifespan and accelerated cellular&#xD;
      processes similar to those of aging. On the other hand, aging is accompanied by the&#xD;
      accumulation of visceral fat and the metabolic complications associated to obesity. Both&#xD;
      obesity and aging have been identified as chronic, low-grade inflammation disorders. The&#xD;
      inflammation in aging has been considered as a risk factor for the development of most of&#xD;
      age-related diseases, and therefore for morbidity and mortality in the elderly. However, the&#xD;
      specific mechanisms leading to inflammation in aging remain largely unknown.&#xD;
&#xD;
      Resolution of inflammation is an active process which involves production of several series&#xD;
      of specialized pro-resolving lipid mediators such lipoxins, resolvin, protectins and maresin.&#xD;
      The hypothesis of this trial is that the chronic inflammation associated to obesity and aging&#xD;
      could be the result of an impaired production of these specialized pro-resolutive lipid&#xD;
      mediators, mainly in adipose tissue. On the other hand, the investigators also propose that&#xD;
      altered transcriptional pattern might be responsible for the development of the inflammation&#xD;
      associated with the pathophysiology of obesity and aging. Therefore the first general aim of&#xD;
      the current project will be to characterize the mechanisms involved in the unresolved chronic&#xD;
      inflammation that arises during obesity and aging.&#xD;
&#xD;
      Because n-3 PUFAs (polyunsaturated fatty acids) serve as substrates for the synthesis of&#xD;
      specialized pro-resolving lipid mediators and are important transcriptional regulators, the&#xD;
      investigators propose that dietary supplementation with n-3 PUFAs, alone or in combination&#xD;
      with regular physical exercise could promote the resolution of local and systemic&#xD;
      inflammation and the subsequent metabolic disorders associated to obesity and aging. A trial&#xD;
      in overweight/obese postmenopausal women will be carried out to characterize the potential&#xD;
      beneficial effects of regular administration of a DHA-rich dietary supplement and/or a&#xD;
      progressive resistance training (PRT) program on weight and fat mass loss, insulin&#xD;
      sensitivity, inflammatory markers and gene/miRNA/lipidomic/metabolomic profile in serum&#xD;
      and/or adipose tissue. Moreover, changes in gut microbiota will be also addressed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 21, 2017</start_date>
  <completion_date type="Actual">June 13, 2019</completion_date>
  <primary_completion_date type="Actual">June 13, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fat mass reduction</measure>
    <time_frame>Week 0 (baseline)</time_frame>
    <description>Evaluation of body fat mass changes induced by the different interventions, analyzed by Dual X-ray Absorptiometry (DXA).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fat mass reduction</measure>
    <time_frame>Week 16 (end of intervention)</time_frame>
    <description>Evaluation of body fat mass changes induced by the different interventions, analyzed by Dual X-ray Absorptiometry (DXA).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evolution of fat mass reduction</measure>
    <time_frame>Week 0 (baseline)</time_frame>
    <description>Evaluation of body fat mass changes induced by the different interventions analyzed by bioimpedance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of fat mass reduction</measure>
    <time_frame>Week 2</time_frame>
    <description>Evaluation of body fat mass changes induced by the different interventions analyzed by bioimpedance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of fat mass reduction</measure>
    <time_frame>Week 4</time_frame>
    <description>Evaluation of body fat mass changes induced by the different interventions analyzed by bioimpedance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of fat mass reduction</measure>
    <time_frame>Week 6</time_frame>
    <description>Evaluation of body fat mass changes induced by the different interventions analyzed by bioimpedance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of fat mass reduction</measure>
    <time_frame>Week 8</time_frame>
    <description>Evaluation of body fat mass changes induced by the different interventions analyzed by bioimpedance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of fat mass reduction</measure>
    <time_frame>Week 10</time_frame>
    <description>Evaluation of body fat mass changes induced by the different interventions analyzed by bioimpedance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of fat mass reduction</measure>
    <time_frame>Week 12</time_frame>
    <description>Evaluation of body fat mass changes induced by the different interventions analyzed by bioimpedance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of fat mass reduction</measure>
    <time_frame>Week 14</time_frame>
    <description>Evaluation of body fat mass changes induced by the different interventions analyzed by bioimpedance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of fat mass reduction</measure>
    <time_frame>Week 16 (end of intervention)</time_frame>
    <description>Evaluation of body fat mass changes induced by the different interventions analyzed by bioimpedance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight loss</measure>
    <time_frame>Week 0 (baseline)</time_frame>
    <description>Changes in body weight will be measured by a body weight scale to the nearest 0.1 kg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight loss</measure>
    <time_frame>Week 2</time_frame>
    <description>Changes in body weight will be measured by a body weight scale to the nearest 0.1 kg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight loss</measure>
    <time_frame>Week 4</time_frame>
    <description>Changes in body weight will be measured by a body weight scale to the nearest 0.1 kg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight loss</measure>
    <time_frame>Week 6</time_frame>
    <description>Changes in body weight will be measured by a body weight scale to the nearest 0.1 kg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight loss</measure>
    <time_frame>Week 8</time_frame>
    <description>Changes in body weight will be measured by a body weight scale to the nearest 0.1 kg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight loss</measure>
    <time_frame>Week 10</time_frame>
    <description>Changes in body weight will be measured by a body weight scale to the nearest 0.1 kg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight loss</measure>
    <time_frame>Week 12</time_frame>
    <description>Changes in body weight will be measured by a body weight scale to the nearest 0.1 kg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight loss</measure>
    <time_frame>Week 14</time_frame>
    <description>Changes in body weight will be measured by a body weight scale to the nearest 0.1 kg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight loss</measure>
    <time_frame>Week 16 (end of intervention)</time_frame>
    <description>Changes in body weight will be measured by a body weight scale to the nearest 0.1 kg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of body composition</measure>
    <time_frame>Week 0 (baseline)</time_frame>
    <description>Evaluation of fat-free mass changes will be analyzed by bioimpedance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of body composition</measure>
    <time_frame>Week 2</time_frame>
    <description>Evaluation of fat-free mass changes will be analyzed by bioimpedance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of body composition</measure>
    <time_frame>Week 4</time_frame>
    <description>Evaluation of fat-free mass changes will be analyzed by bioimpedance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of body composition</measure>
    <time_frame>Week 6</time_frame>
    <description>Evaluation of fat-free mass changes will be analyzed by bioimpedance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of body composition</measure>
    <time_frame>Week 8</time_frame>
    <description>Evaluation of fat-free mass changes will be analyzed by bioimpedance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of body composition</measure>
    <time_frame>Week 10</time_frame>
    <description>Evaluation of fat-free mass changes will be analyzed by bioimpedance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of body composition</measure>
    <time_frame>Week 12</time_frame>
    <description>Evaluation of fat-free mass changes will be analyzed by bioimpedance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of body composition</measure>
    <time_frame>Week 14</time_frame>
    <description>Evaluation of fat-free mass changes will be analyzed by bioimpedance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of body composition</measure>
    <time_frame>Week 16 (end of intervention)</time_frame>
    <description>Evaluation of fat-free mass changes will be analyzed by bioimpedance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hip circumference</measure>
    <time_frame>Week 0 (baseline)</time_frame>
    <description>Hip circumference will be measured with a measuring tape.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hip circumference</measure>
    <time_frame>Week 8</time_frame>
    <description>Hip circumference will be measured with a measuring tape.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hip circumference</measure>
    <time_frame>Week 16 (end of intervention)</time_frame>
    <description>Hip circumference will be measured with a measuring tape.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neck circumference</measure>
    <time_frame>Week 0 (baseline)</time_frame>
    <description>Neck circumference will be measured with a measuring tape.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neck circumference</measure>
    <time_frame>Week 8</time_frame>
    <description>Neck circumference will be measured with a measuring tape.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neck circumference</measure>
    <time_frame>Week 16 (end of intervention)</time_frame>
    <description>Neck circumference will be measured with a measuring tape.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist circumference</measure>
    <time_frame>Week 0 (baseline)</time_frame>
    <description>Waist circumference will be measured with a measuring tape.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist circumference</measure>
    <time_frame>Week 8</time_frame>
    <description>Waist circumference will be measured with a measuring tape.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist circumference</measure>
    <time_frame>Week 16 (end of intervention)</time_frame>
    <description>Waist circumference will be measured with a measuring tape.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Abdomen circumference</measure>
    <time_frame>Week 0 (baseline)</time_frame>
    <description>Abdomen circumference will be measured with a measuring tape.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Abdomen circumference</measure>
    <time_frame>Week 8</time_frame>
    <description>Abdomen circumference will be measured with a measuring tape.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Abdomen circumference</measure>
    <time_frame>Week 16 (end of intervention)</time_frame>
    <description>Abdomen circumference will be measured with a measuring tape.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arm circumference</measure>
    <time_frame>Week 0 (baseline)</time_frame>
    <description>Arm circumference will be measured with a measuring tape.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arm circumference</measure>
    <time_frame>Week 8</time_frame>
    <description>Arm circumference will be measured with a measuring tape.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arm circumference</measure>
    <time_frame>Week 16 (end of intervention)</time_frame>
    <description>Arm circumference will be measured with a measuring tape.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Midthigh circumference</measure>
    <time_frame>Week 0 (baseline)</time_frame>
    <description>Midthigh circumference will be measured with a measuring tape.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Midthigh circumference</measure>
    <time_frame>Week 8</time_frame>
    <description>Midthigh circumference will be measured with a measuring tape.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Midthigh circumference</measure>
    <time_frame>Week 16 (end of intervention)</time_frame>
    <description>Midthigh circumference will be measured with a measuring tape.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Midcalf circumference</measure>
    <time_frame>Week 0 (baseline)</time_frame>
    <description>Midcalf circumference will be measured with a measuring tape.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Midcalf circumference</measure>
    <time_frame>Week 8</time_frame>
    <description>Midcalf circumference will be measured with a measuring tape.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Midcalf circumference</measure>
    <time_frame>Week 16 (end of intervention)</time_frame>
    <description>Midcalf circumference will be measured with a measuring tape.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Triceps skinfold</measure>
    <time_frame>Week 0 (baseline)</time_frame>
    <description>Triceps skinfold will be measured with a caliper.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Triceps skinfold</measure>
    <time_frame>Week 8</time_frame>
    <description>Triceps skinfold will be measured with a caliper.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Triceps skinfold</measure>
    <time_frame>Week 16 (end of intervention)</time_frame>
    <description>Triceps skinfold will be measured with a caliper.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thigh skinfold</measure>
    <time_frame>Week 0 (baseline)</time_frame>
    <description>Thigh skinfold will be measured with a caliper.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thigh skinfold</measure>
    <time_frame>Week 8</time_frame>
    <description>Thigh skinfold will be measured with a caliper.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thigh skinfold</measure>
    <time_frame>Week 16 (end of intervention)</time_frame>
    <description>Thigh skinfold will be measured with a caliper.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medial calf skinfold</measure>
    <time_frame>Week 0 (baseline)</time_frame>
    <description>Medial calf skinfold will be measured with a caliper.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medial calf skinfold</measure>
    <time_frame>Week 8</time_frame>
    <description>Medial calf skinfold will be measured with a caliper.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medial calf skinfold</measure>
    <time_frame>Week 16 (end of intervention)</time_frame>
    <description>Medial calf skinfold will be measured with a caliper.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>Week 0 (baseline)</time_frame>
    <description>Systolic and diastolic blood pressure will be measured with a tensiometer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>Week 8</time_frame>
    <description>Systolic and diastolic blood pressure will be measured with a tensiometer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>Week 16 (end of intervention)</time_frame>
    <description>Systolic and diastolic blood pressure will be measured with a tensiometer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum glucose</measure>
    <time_frame>Week 0 (baseline)</time_frame>
    <description>Fasting serum glucose will be measured after overnight fast.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum glucose</measure>
    <time_frame>Week 16 (end of intervention)</time_frame>
    <description>Fasting serum glucose will be measured after overnight fast.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum insulin</measure>
    <time_frame>Week 0 (baseline)</time_frame>
    <description>Fasting serum insulin will be measured after overnight fast.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum insulin</measure>
    <time_frame>Week 16 (end of intervention)</time_frame>
    <description>Fasting serum insulin will be measured after overnight fast.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oral Glucose Tolerance Test</measure>
    <time_frame>Week 0 (baseline)</time_frame>
    <description>Oral Glucose Tolerance Test will be carried out after overnight fast.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oral Glucose Tolerance Test</measure>
    <time_frame>Week 16 (end of intervention)</time_frame>
    <description>Oral Glucose Tolerance Test will be carried out after overnight fast.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lipid metabolism biomarkers</measure>
    <time_frame>Week 0 (baseline)</time_frame>
    <description>Serum free fatty acids, triglycerides, total cholesterol, LDL-cholesterol and HDL-cholesterol concentrations will be measured after an overnight fast.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lipid metabolism biomarkers</measure>
    <time_frame>Week 16 (end of intervention)</time_frame>
    <description>Serum free fatty acids, triglycerides, total cholesterol, LDL-cholesterol and HDL-cholesterol concentrations will be measured after an overnight fast.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ketone bodies</measure>
    <time_frame>Week 0 (baseline)</time_frame>
    <description>Ketone bodies concentrations will be measured after an overnight fast.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ketone bodies</measure>
    <time_frame>Week 16 (end of intervention)</time_frame>
    <description>Ketone bodies concentrations will be measured after an overnight fast.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thyroid function (body metabolism)</measure>
    <time_frame>Week 0 (baseline)</time_frame>
    <description>TSH (thyroid-stimulating hormone), T3 and T4 hormones will be evaluated with ELISA kits</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thyroid function (body metabolism)</measure>
    <time_frame>Week 16 (end of intervention)</time_frame>
    <description>TSH (thyroid-stimulating hormone), T3 and T4 hormones will be evaluated with ELISA kits</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular risk biomarkers</measure>
    <time_frame>Week 0 (baseline)</time_frame>
    <description>PAI-1 (plasminogen activator inhibitor-1), ADMA (asymmetric dimethylarginine) and VEGF (vascular endothelial growth factor) will be measured in plasma using ELISA kits</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular risk biomarkers</measure>
    <time_frame>Week 16 (end of intervention)</time_frame>
    <description>PAI-1 (plasminogen activator inhibitor-1), ADMA (asymmetric dimethylarginine) and VEGF (vascular endothelial growth factor) will be measured in plasma using ELISA kits</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammation biomarkers</measure>
    <time_frame>Week 0 (baseline)</time_frame>
    <description>TNF-α (tumour necrosis factor-alpha), IL-6 (interleukin 6), C-reactive protein, serum A-amyloid, leptin, adiponectin, chemerin will be measured by ELISA kits</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammation biomarkers</measure>
    <time_frame>Week 16 (end of intervention)</time_frame>
    <description>TNF-α (tumour necrosis factor-alpha), IL-6 (interleukin 6), C-reactive protein, serum A-amyloid, leptin, adiponectin, chemerin will be measured in plasma by ELISA kits</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satiety and eating behavior traits</measure>
    <time_frame>Week 0 (baseline)</time_frame>
    <description>Satiety will be also estimated by using a VAS (visual analogue scale) questionnaire and eating behavior traits will be also evaluated with validated questionnaires</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satiety and eating behavior traits</measure>
    <time_frame>Week 16 (end of intervention)</time_frame>
    <description>Satiety will be also estimated by using a VAS (visual analogue scale) questionnaire and eating behavior traits will be also evaluated with validated questionnaires</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma adipokines and myo-kines</measure>
    <time_frame>Week 0 (baseline)</time_frame>
    <description>CT-1, irisin, FGF21 (fibroblast growth factor 21) and meteorin-like will be measured using ELISA kits</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma adipokines and myo-kines</measure>
    <time_frame>Week 16 (end of intervention)</time_frame>
    <description>CT-1, irisin, FGF21 (fibroblast growth factor 21) and meteorin-like will be measured using ELISA kits</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma lipids and bioactive lipid mediators</measure>
    <time_frame>Week 0 (baseline)</time_frame>
    <description>Lipidomic profile will be measured using targeted metabolomic-lipidomics by HPLC-MS (high pressure liquid chromatography-mass spectrometry).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma lipids and bioactive lipid mediators</measure>
    <time_frame>Week 16 (end of intervention)</time_frame>
    <description>Lipidomic profile will be measured using targeted metabolomic-lipidomics by HPLC-MS (high pressure liquid chromatography-mass spectrometry).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adipose tissue gene profiling</measure>
    <time_frame>Week 0 (baseline)</time_frame>
    <description>A biopsy (2 g) of subcutaneous abdominal periumbilical area adipose tissue will be obtained by liposuction under local anesthesia. RNA expression will be measured by RNA-seq or GeneChip Human Gene 2.1 ST Array (Affymetrix).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adipose tissue gene profiling</measure>
    <time_frame>Week 16 (end of intervention)</time_frame>
    <description>A biopsy (2 g) of subcutaneous abdominal periumbilical area adipose tissue will be obtained by liposuction under local anesthesia. RNA expression will be measured by RNA-seq or GeneChip Human Gene 2.1 ST Array (Affymetrix).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adipose tissue miRNA profiling</measure>
    <time_frame>Week 0 (baseline)</time_frame>
    <description>MiRNA expression will be measured by RNA-seq or GeneChip miRNA 4.0 Array (Affymetrix) in subcutaneous abdominal adipose tissue biopsies.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adipose tissue miRNA profiling</measure>
    <time_frame>Week 16 (end of intervention)</time_frame>
    <description>MiRNA expression will be measured by RNA-seq or GeneChip miRNA 4.0 Array (Affymetrix) in subcutaneous abdominal adipose tissue biopsies.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bioactive lipid mediators involved in inflammation in adipose tissue</measure>
    <time_frame>Week 0 (baseline)</time_frame>
    <description>Lipidomic profile will be measured using targeted metabolomic-lipidomics by HPLC-MS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bioactive lipid mediators involved in inflammation in adipose tissue</measure>
    <time_frame>Week 16 (end of intervention)</time_frame>
    <description>Lipidomic profile will be measured using targeted metabolomic-lipidomics by HPLC-MS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Determination of telomeres length</measure>
    <time_frame>Week 0 (baseline)</time_frame>
    <description>Telomeres length will be measured in genomic DNA extracted from human peripheral blood and adipose tissue samples with a real-time quantitative PCR (polymerase chain reaction) approach.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Determination of telomeres length</measure>
    <time_frame>Week 16 (end of intervention)</time_frame>
    <description>Telomeres length will be measured in genomic DNA extracted from human peripheral blood and adipose tissue samples with a real-time quantitative PCR (polymerase chain reaction) approach.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Characterization of gut microbiota</measure>
    <time_frame>Week 0 (baseline)</time_frame>
    <description>Feces will collected and gut microbiota profiling will be carried out by high-throughput 16S (Svedberg units) rDNA (ribosomal deoxyribonucleic acid) amplicon sequencing approach.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Characterization of gut microbiota</measure>
    <time_frame>Week 16 (end of intervention)</time_frame>
    <description>Feces will collected and gut microbiota profiling will be carried out by high-throughput 16S (Svedberg units) rDNA (ribosomal deoxyribonucleic acid) amplicon sequencing approach.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urine metabolomic profile</measure>
    <time_frame>Week 0 (baseline)</time_frame>
    <description>Urine will be collected and urinary metabolomic profile will be also evaluated by a HPLC-MS approach.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urine metabolomic profile</measure>
    <time_frame>Week 16 (end of intervention)</time_frame>
    <description>Urine will be collected and urinary metabolomic profile will be also evaluated by a HPLC-MS approach.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">85</enrollment>
  <condition>Obesity</condition>
  <condition>Aging</condition>
  <condition>Inflammation</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Dietary advice for a healthy diet supplemented with placebo (olive oil).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Omega-3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dietary advice for a healthy diet supplemented with DHA-rich dietary supplement (providing 1.650 mg/day of DHA).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Resistance Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dietary advice for a healthy diet supplemented with placebo (olive oil) and moderate resistance training program.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Omega-3 + Resistance Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dietary advice for a healthy diet supplemented with a DHA-rich dietary supplement (providing 1.650 mg/day of DHA) and moderate resistance training program.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Omega-3 (DHA-rich dietary supplement)</intervention_name>
    <description>Double-blind randomized placebo-controlled intervention with DHA-rich dietary supplement with or without resistance training program for 16 weeks.</description>
    <arm_group_label>Omega-3</arm_group_label>
    <arm_group_label>Omega-3 + Resistance Training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo (olive oil)</intervention_name>
    <description>Double-blind randomized placebo-controlled intervention with DHA-rich dietary supplement with or without resistance training program for 16 weeks.</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Resistance Training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Resistance training</intervention_name>
    <description>Double-blind randomized placebo-controlled intervention with DHA-rich dietary supplement with or without resistance training program for 16 weeks.</description>
    <arm_group_label>Omega-3 + Resistance Training</arm_group_label>
    <arm_group_label>Resistance Training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Post-menopausal women&#xD;
&#xD;
          -  Age between 55 and 70 years&#xD;
&#xD;
          -  Body Mass Index (BMI) between 27.5 and 35 kg/m²&#xD;
&#xD;
          -  Weight unchanged (± 3 kg) for the last 3 months&#xD;
&#xD;
          -  Overall physical and psychological condition that the investigator believes is in&#xD;
             accordance with the overall aim of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of regular prescription medication: specially statins, antidiabetic drugs,&#xD;
             menopausal hormone replacement therapy&#xD;
&#xD;
          -  To suffer from any chronic metabolic condition: severe dislipidemia, type 1 or 2&#xD;
             diabetes, hepatic (cirrhosis), renal disease, cardiovascular disease, neuromuscular&#xD;
             disease, arthritic disease, pulmonary disease and/or other debilitating diseases&#xD;
&#xD;
          -  Food allergies and/or food intolerance expected to come up during the study&#xD;
&#xD;
          -  Following special diets (Atkins, vegetarian, etc.) prior three months the start of the&#xD;
             study&#xD;
&#xD;
          -  Eating disorders&#xD;
&#xD;
          -  Surgically treated obesity&#xD;
&#xD;
          -  Alcohol or drug abuse&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>María J Moreno-Aliaga, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Navarra</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Silvia Lorente-Cebrián, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Navarra</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Nutrition, Food Science and Physiology. Centre for Nutrition Research.</name>
      <address>
        <city>Pamplona</city>
        <state>Navarra</state>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <link>
    <url>http://www.unav.edu/web/centro-de-investigacion-en-nutricion</url>
    <description>Centre for Nutrition Research. University of Navarra</description>
  </link>
  <reference>
    <citation>Martinez-Fernandez L, Gonzalez-Muniesa P, Laiglesia LM, Sainz N, Prieto-Hontoria PL, Escote X, Odriozola L, Corrales FJ, Arbones-Mainar JM, Martinez JA, Moreno-Aliaga MJ. Maresin 1 improves insulin sensitivity and attenuates adipose tissue inflammation in ob/ob and diet-induced obese mice. FASEB J. 2017 May;31(5):2135-2145. doi: 10.1096/fj.201600859R. Epub 2017 Feb 10.</citation>
    <PMID>28188173</PMID>
  </reference>
  <reference>
    <citation>Lopez-Yoldi M, Stanhope KL, Garaulet M, Chen XG, Marcos-Gomez B, Carrasco-Benso MP, Santa Maria EM, Escote X, Lee V, Nunez MV, Medici V, Martinez-Anso E, Sainz N, Huerta AE, Laiglesia LM, Prieto J, Martinez JA, Bustos M, Havel PJ, Moreno-Aliaga MJ. Role of cardiotrophin-1 in the regulation of metabolic circadian rhythms and adipose core clock genes in mice and characterization of 24-h circulating CT-1 profiles in normal-weight and overweight/obese subjects. FASEB J. 2017 Apr;31(4):1639-1649. doi: 10.1096/fj.201600396RR. Epub 2017 Jan 17.</citation>
    <PMID>28096235</PMID>
  </reference>
  <reference>
    <citation>Laiglesia LM, Lorente-Cebrian S, Prieto-Hontoria PL, Fernandez-Galilea M, Ribeiro SM, Sainz N, Martinez JA, Moreno-Aliaga MJ. Eicosapentaenoic acid promotes mitochondrial biogenesis and beige-like features in subcutaneous adipocytes from overweight subjects. J Nutr Biochem. 2016 Nov;37:76-82. doi: 10.1016/j.jnutbio.2016.07.019. Epub 2016 Aug 26.</citation>
    <PMID>27637001</PMID>
  </reference>
  <reference>
    <citation>Huerta AE, Prieto-Hontoria PL, Fernandez-Galilea M, Escote X, Martinez JA, Moreno-Aliaga MJ. Effects of dietary supplementation with EPA and/or alpha-lipoic acid on adipose tissue transcriptomic profile of healthy overweight/obese women following a hypocaloric diet. Biofactors. 2017 Jan 2;43(1):117-131. doi: 10.1002/biof.1317. Epub 2016 Aug 10.</citation>
    <PMID>27507611</PMID>
  </reference>
  <reference>
    <citation>Huerta AE, Prieto-Hontoria PL, Sainz N, Martinez JA, Moreno-Aliaga MJ. Supplementation with alpha-Lipoic Acid Alone or in Combination with Eicosapentaenoic Acid Modulates the Inflammatory Status of Healthy Overweight or Obese Women Consuming an Energy-Restricted Diet. J Nutr. 2015 Apr 1;146(4):889S-896S. doi: 10.3945/jn.115.224105.</citation>
    <PMID>26962183</PMID>
  </reference>
  <reference>
    <citation>Milagro FI, Moreno-Aliaga MJ, Martinez JA. FTO Obesity Variant and Adipocyte Browning in Humans. N Engl J Med. 2016 Jan 14;374(2):190-1. doi: 10.1056/NEJMc1513316. No abstract available.</citation>
    <PMID>26760097</PMID>
  </reference>
  <reference>
    <citation>Prieto-Hontoria PL, Perez-Matute P, Fernandez-Galilea M, Lopez-Yoldi M, Sinal CJ, Martinez JA, Moreno-Aliaga MJ. Effects of alpha-lipoic acid on chemerin secretion in 3T3-L1 and human adipocytes. Biochim Biophys Acta. 2016 Mar;1861(3):260-8. doi: 10.1016/j.bbalip.2015.12.011. Epub 2015 Dec 22.</citation>
    <PMID>26721419</PMID>
  </reference>
  <reference>
    <citation>Martinez-Fernandez L, Laiglesia LM, Huerta AE, Martinez JA, Moreno-Aliaga MJ. Omega-3 fatty acids and adipose tissue function in obesity and metabolic syndrome. Prostaglandins Other Lipid Mediat. 2015 Sep;121(Pt A):24-41. doi: 10.1016/j.prostaglandins.2015.07.003. Epub 2015 Jul 26.</citation>
    <PMID>26219838</PMID>
  </reference>
  <reference>
    <citation>Mansego ML, Milagro FI, Zulet MA, Moreno-Aliaga MJ, Martinez JA. Differential DNA Methylation in Relation to Age and Health Risks of Obesity. Int J Mol Sci. 2015 Jul 24;16(8):16816-32. doi: 10.3390/ijms160816816.</citation>
    <PMID>26213922</PMID>
  </reference>
  <reference>
    <citation>Huerta AE, Prieto-Hontoria PL, Fernandez-Galilea M, Sainz N, Cuervo M, Martinez JA, Moreno-Aliaga MJ. Circulating irisin and glucose metabolism in overweight/obese women: effects of alpha-lipoic acid and eicosapentaenoic acid. J Physiol Biochem. 2015 Sep;71(3):547-58. doi: 10.1007/s13105-015-0400-5. Epub 2015 Mar 28.</citation>
    <PMID>25820474</PMID>
  </reference>
  <reference>
    <citation>Lorente-Cebrian S, Costa AG, Navas-Carretero S, Zabala M, Laiglesia LM, Martinez JA, Moreno-Aliaga MJ. An update on the role of omega-3 fatty acids on inflammatory and degenerative diseases. J Physiol Biochem. 2015 Jun;71(2):341-9. doi: 10.1007/s13105-015-0395-y. Epub 2015 Mar 11.</citation>
    <PMID>25752887</PMID>
  </reference>
  <reference>
    <citation>Huerta AE, Navas-Carretero S, Prieto-Hontoria PL, Martinez JA, Moreno-Aliaga MJ. Effects of alpha-lipoic acid and eicosapentaenoic acid in overweight and obese women during weight loss. Obesity (Silver Spring). 2015 Feb;23(2):313-21. doi: 10.1002/oby.20966. Epub 2014 Dec 31.</citation>
    <PMID>25594166</PMID>
  </reference>
  <reference>
    <citation>Gonzalez-Muniesa P, Marrades MP, Martinez JA, Moreno-Aliaga MJ. Differential proinflammatory and oxidative stress response and vulnerability to metabolic syndrome in habitual high-fat young male consumers putatively predisposed by their genetic background. Int J Mol Sci. 2013 Aug 22;14(9):17238-55. doi: 10.3390/ijms140917238.</citation>
    <PMID>23975165</PMID>
  </reference>
  <reference>
    <citation>Lorente-Cebrian S, Costa AG, Navas-Carretero S, Zabala M, Martinez JA, Moreno-Aliaga MJ. Role of omega-3 fatty acids in obesity, metabolic syndrome, and cardiovascular diseases: a review of the evidence. J Physiol Biochem. 2013 Sep;69(3):633-51. doi: 10.1007/s13105-013-0265-4. Epub 2013 Jun 22.</citation>
    <PMID>23794360</PMID>
  </reference>
  <reference>
    <citation>Lorente-Cebrian S, Bustos M, Marti A, Fernandez-Galilea M, Martinez JA, Moreno-Aliaga MJ. Eicosapentaenoic acid inhibits tumour necrosis factor-alpha-induced lipolysis in murine cultured adipocytes. J Nutr Biochem. 2012 Mar;23(3):218-27. doi: 10.1016/j.jnutbio.2010.11.018. Epub 2011 Apr 14.</citation>
    <PMID>21497077</PMID>
  </reference>
  <reference>
    <citation>Marrades MP, Gonzalez-Muniesa P, Martinez JA, Moreno-Aliaga MJ. A dysregulation in CES1, APOE and other lipid metabolism-related genes is associated to cardiovascular risk factors linked to obesity. Obes Facts. 2010 Oct;3(5):312-8. doi: 10.1159/000321451. Epub 2010 Oct 15.</citation>
    <PMID>20975297</PMID>
  </reference>
  <reference>
    <citation>Marrades MP, Gonzalez-Muniesa P, Arteta D, Martinez JA, Moreno-Aliaga MJ. Orchestrated downregulation of genes involved in oxidative metabolic pathways in obese vs. lean high-fat young male consumers. J Physiol Biochem. 2011 Mar;67(1):15-26. doi: 10.1007/s13105-010-0044-4. Epub 2010 Sep 30.</citation>
    <PMID>20882379</PMID>
  </reference>
  <reference>
    <citation>Moreno-Aliaga MJ, Lorente-Cebrian S, Martinez JA. Regulation of adipokine secretion by n-3 fatty acids. Proc Nutr Soc. 2010 Aug;69(3):324-32. doi: 10.1017/S0029665110001801. Epub 2010 Jun 14.</citation>
    <PMID>20540825</PMID>
  </reference>
  <reference>
    <citation>Lorente-Cebrian S, Bustos M, Marti A, Martinez JA, Moreno-Aliaga MJ. Eicosapentaenoic acid up-regulates apelin secretion and gene expression in 3T3-L1 adipocytes. Mol Nutr Food Res. 2010 May;54 Suppl 1:S104-11. doi: 10.1002/mnfr.200900522.</citation>
    <PMID>20352620</PMID>
  </reference>
  <reference>
    <citation>Lorente-Cebrian S, Bustos M, Marti A, Martinez JA, Moreno-Aliaga MJ. Eicosapentaenoic acid stimulates AMP-activated protein kinase and increases visfatin secretion in cultured murine adipocytes. Clin Sci (Lond). 2009 Aug 14;117(6):243-9. doi: 10.1042/CS20090020.</citation>
    <PMID>19296827</PMID>
  </reference>
  <reference>
    <citation>Perez-Echarri N, Perez-Matute P, Marcos-Gomez B, Marti A, Martinez JA, Moreno-Aliaga MJ. Down-regulation in muscle and liver lipogenic genes: EPA ethyl ester treatment in lean and overweight (high-fat-fed) rats. J Nutr Biochem. 2009 Sep;20(9):705-14. doi: 10.1016/j.jnutbio.2008.06.013. Epub 2008 Sep 30.</citation>
    <PMID>18829285</PMID>
  </reference>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>November 26, 2020</last_update_submitted>
  <last_update_submitted_qc>November 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Insulin resistance</keyword>
  <keyword>Exercise</keyword>
  <keyword>Omega-3 fatty acids</keyword>
  <keyword>Adipose tissue</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03300388
org study id: OBELEX
nct id: NCT03300388
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Dysfunction of adipose tissue in obesity, inflammation and aging: mechanisms and effects of
      physical exercise and omega-3 fatty acids.
Obesity is associated with the development of metabolic diseases including type 2 diabetes
      and immune disorders. Obesity also leads to reduced lifespan and accelerated cellular
      processes similar to those of aging. On the other hand, aging is accompanied by the
      accumulation of visceral fat and the metabolic complications associated to obesity. Both
      obesity and aging have been identified as chronic, low-grade inflammation disorders. The
      inflammation in aging has been considered as a risk factor for the development of most of
      age-related diseases, and therefore for morbidity and mortality in the elderly. However, the
      specific mechanisms leading to inflammation in aging remain largely unknown.

      Resolution of inflammation is an active process which involves production of several series
      of specialized pro-resolving lipid mediators such lipoxins, resolvin, protectins and maresin.
      The hypothesis of this trial is that the chronic inflammation associated to obesity and aging
      could be the result of an impaired production of these specialized pro-resolutive lipid
      mediators, mainly in adipose tissue. On the other hand, the investigators also propose that
      altered transcriptional pattern might be responsible for the development of the inflammation
      associated with the pathophysiology of obesity and aging. Therefore the first general aim of
      the current project will be to characterize the mechanisms involved in the unresolved chronic
      inflammation that arises during obesity and aging.

      Because n-3 PUFAs (polyunsaturated fatty acids) serve as substrates for the synthesis of
      specialized pro-resolving lipid mediators and are important transcriptional regulators, the
      investigators propose that dietary supplementation with n-3 PUFAs, alone or in combination
      with regular physical exercise could promote the resolution of local and systemic
      inflammation and the subsequent metabolic disorders associated to obesity and aging. A trial
      in overweight/obese postmenopausal women will be carried out to characterize the potential
      beneficial effects of regular administration of a DHA-rich dietary supplement and/or a
      progressive resistance training (PRT) program on weight and fat mass loss, insulin
      sensitivity, inflammatory markers and gene/miRNA/lipidomic/metabolomic profile in serum
      and/or adipose tissue. Moreover, changes in gut microbiota will be also addressed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Fat mass reduction
time frame: Week 0 (baseline)
description: Evaluation of body fat mass changes induced by the different interventions, analyzed by Dual X-ray Absorptiometry (DXA).
measure: Fat mass reduction
time frame: Week 16 (end of intervention)
description: Evaluation of body fat mass changes induced by the different interventions, analyzed by Dual X-ray Absorptiometry (DXA).
measure: Evolution of fat mass reduction
time frame: Week 0 (baseline)
description: Evaluation of body fat mass changes induced by the different interventions analyzed by bioimpedance.
measure: Evolution of fat mass reduction
time frame: Week 2
description: Evaluation of body fat mass changes induced by the different interventions analyzed by bioimpedance.
measure: Evolution of fat mass reduction
time frame: Week 4
description: Evaluation of body fat mass changes induced by the different interventions analyzed by bioimpedance.
measure: Evolution of fat mass reduction
time frame: Week 6
description: Evaluation of body fat mass changes induced by the different interventions analyzed by bioimpedance.
measure: Evolution of fat mass reduction
time frame: Week 8
description: Evaluation of body fat mass changes induced by the different interventions analyzed by bioimpedance.
measure: Evolution of fat mass reduction
time frame: Week 10
description: Evaluation of body fat mass changes induced by the different interventions analyzed by bioimpedance.
measure: Evolution of fat mass reduction
time frame: Week 12
description: Evaluation of body fat mass changes induced by the different interventions analyzed by bioimpedance.
measure: Evolution of fat mass reduction
time frame: Week 14
description: Evaluation of body fat mass changes induced by the different interventions analyzed by bioimpedance.
measure: Evolution of fat mass reduction
time frame: Week 16 (end of intervention)
description: Evaluation of body fat mass changes induced by the different interventions analyzed by bioimpedance.
measure: Weight loss
time frame: Week 0 (baseline)
description: Changes in body weight will be measured by a body weight scale to the nearest 0.1 kg
measure: Weight loss
time frame: Week 2
description: Changes in body weight will be measured by a body weight scale to the nearest 0.1 kg
measure: Weight loss
time frame: Week 4
description: Changes in body weight will be measured by a body weight scale to the nearest 0.1 kg
measure: Weight loss
time frame: Week 6
description: Changes in body weight will be measured by a body weight scale to the nearest 0.1 kg
measure: Weight loss
time frame: Week 8
description: Changes in body weight will be measured by a body weight scale to the nearest 0.1 kg
measure: Weight loss
time frame: Week 10
description: Changes in body weight will be measured by a body weight scale to the nearest 0.1 kg
measure: Weight loss
time frame: Week 12
description: Changes in body weight will be measured by a body weight scale to the nearest 0.1 kg
measure: Weight loss
time frame: Week 14
description: Changes in body weight will be measured by a body weight scale to the nearest 0.1 kg
measure: Weight loss
time frame: Week 16 (end of intervention)
description: Changes in body weight will be measured by a body weight scale to the nearest 0.1 kg
measure: Evolution of body composition
time frame: Week 0 (baseline)
description: Evaluation of fat-free mass changes will be analyzed by bioimpedance.
measure: Evolution of body composition
time frame: Week 2
description: Evaluation of fat-free mass changes will be analyzed by bioimpedance.
measure: Evolution of body composition
time frame: Week 4
description: Evaluation of fat-free mass changes will be analyzed by bioimpedance.
measure: Evolution of body composition
time frame: Week 6
description: Evaluation of fat-free mass changes will be analyzed by bioimpedance.
measure: Evolution of body composition
time frame: Week 8
description: Evaluation of fat-free mass changes will be analyzed by bioimpedance.
measure: Evolution of body composition
time frame: Week 10
description: Evaluation of fat-free mass changes will be analyzed by bioimpedance.
measure: Evolution of body composition
time frame: Week 12
description: Evaluation of fat-free mass changes will be analyzed by bioimpedance.
measure: Evolution of body composition
time frame: Week 14
description: Evaluation of fat-free mass changes will be analyzed by bioimpedance.
measure: Evolution of body composition
time frame: Week 16 (end of intervention)
description: Evaluation of fat-free mass changes will be analyzed by bioimpedance.
measure: Hip circumference
time frame: Week 0 (baseline)
description: Hip circumference will be measured with a measuring tape.
measure: Hip circumference
time frame: Week 8
description: Hip circumference will be measured with a measuring tape.
measure: Hip circumference
time frame: Week 16 (end of intervention)
description: Hip circumference will be measured with a measuring tape.
measure: Neck circumference
time frame: Week 0 (baseline)
description: Neck circumference will be measured with a measuring tape.
measure: Neck circumference
time frame: Week 8
description: Neck circumference will be measured with a measuring tape.
measure: Neck circumference
time frame: Week 16 (end of intervention)
description: Neck circumference will be measured with a measuring tape.
measure: Waist circumference
time frame: Week 0 (baseline)
description: Waist circumference will be measured with a measuring tape.
measure: Waist circumference
time frame: Week 8
description: Waist circumference will be measured with a measuring tape.
measure: Waist circumference
time frame: Week 16 (end of intervention)
description: Waist circumference will be measured with a measuring tape.
measure: Abdomen circumference
time frame: Week 0 (baseline)
description: Abdomen circumference will be measured with a measuring tape.
measure: Abdomen circumference
time frame: Week 8
description: Abdomen circumference will be measured with a measuring tape.
measure: Abdomen circumference
time frame: Week 16 (end of intervention)
description: Abdomen circumference will be measured with a measuring tape.
measure: Arm circumference
time frame: Week 0 (baseline)
description: Arm circumference will be measured with a measuring tape.
measure: Arm circumference
time frame: Week 8
description: Arm circumference will be measured with a measuring tape.
measure: Arm circumference
time frame: Week 16 (end of intervention)
description: Arm circumference will be measured with a measuring tape.
measure: Midthigh circumference
time frame: Week 0 (baseline)
description: Midthigh circumference will be measured with a measuring tape.
measure: Midthigh circumference
time frame: Week 8
description: Midthigh circumference will be measured with a measuring tape.
measure: Midthigh circumference
time frame: Week 16 (end of intervention)
description: Midthigh circumference will be measured with a measuring tape.
measure: Midcalf circumference
time frame: Week 0 (baseline)
description: Midcalf circumference will be measured with a measuring tape.
measure: Midcalf circumference
time frame: Week 8
description: Midcalf circumference will be measured with a measuring tape.
measure: Midcalf circumference
time frame: Week 16 (end of intervention)
description: Midcalf circumference will be measured with a measuring tape.
measure: Triceps skinfold
time frame: Week 0 (baseline)
description: Triceps skinfold will be measured with a caliper.
measure: Triceps skinfold
time frame: Week 8
description: Triceps skinfold will be measured with a caliper.
measure: Triceps skinfold
time frame: Week 16 (end of intervention)
description: Triceps skinfold will be measured with a caliper.
measure: Thigh skinfold
time frame: Week 0 (baseline)
description: Thigh skinfold will be measured with a caliper.
measure: Thigh skinfold
time frame: Week 8
description: Thigh skinfold will be measured with a caliper.
measure: Thigh skinfold
time frame: Week 16 (end of intervention)
description: Thigh skinfold will be measured with a caliper.
measure: Medial calf skinfold
time frame: Week 0 (baseline)
description: Medial calf skinfold will be measured with a caliper.
measure: Medial calf skinfold
time frame: Week 8
description: Medial calf skinfold will be measured with a caliper.
measure: Medial calf skinfold
time frame: Week 16 (end of intervention)
description: Medial calf skinfold will be measured with a caliper.
measure: Blood pressure
time frame: Week 0 (baseline)
description: Systolic and diastolic blood pressure will be measured with a tensiometer.
measure: Blood pressure
time frame: Week 8
description: Systolic and diastolic blood pressure will be measured with a tensiometer.
measure: Blood pressure
time frame: Week 16 (end of intervention)
description: Systolic and diastolic blood pressure will be measured with a tensiometer.
measure: Serum glucose
time frame: Week 0 (baseline)
description: Fasting serum glucose will be measured after overnight fast.
measure: Serum glucose
time frame: Week 16 (end of intervention)
description: Fasting serum glucose will be measured after overnight fast.
measure: Serum insulin
time frame: Week 0 (baseline)
description: Fasting serum insulin will be measured after overnight fast.
measure: Serum insulin
time frame: Week 16 (end of intervention)
description: Fasting serum insulin will be measured after overnight fast.
measure: Oral Glucose Tolerance Test
time frame: Week 0 (baseline)
description: Oral Glucose Tolerance Test will be carried out after overnight fast.
measure: Oral Glucose Tolerance Test
time frame: Week 16 (end of intervention)
description: Oral Glucose Tolerance Test will be carried out after overnight fast.
measure: Lipid metabolism biomarkers
time frame: Week 0 (baseline)
description: Serum free fatty acids, triglycerides, total cholesterol, LDL-cholesterol and HDL-cholesterol concentrations will be measured after an overnight fast.
measure: Lipid metabolism biomarkers
time frame: Week 16 (end of intervention)
description: Serum free fatty acids, triglycerides, total cholesterol, LDL-cholesterol and HDL-cholesterol concentrations will be measured after an overnight fast.
measure: Ketone bodies
time frame: Week 0 (baseline)
description: Ketone bodies concentrations will be measured after an overnight fast.
measure: Ketone bodies
time frame: Week 16 (end of intervention)
description: Ketone bodies concentrations will be measured after an overnight fast.
measure: Thyroid function (body metabolism)
time frame: Week 0 (baseline)
description: TSH (thyroid-stimulating hormone), T3 and T4 hormones will be evaluated with ELISA kits
measure: Thyroid function (body metabolism)
time frame: Week 16 (end of intervention)
description: TSH (thyroid-stimulating hormone), T3 and T4 hormones will be evaluated with ELISA kits
measure: Cardiovascular risk biomarkers
time frame: Week 0 (baseline)
description: PAI-1 (plasminogen activator inhibitor-1), ADMA (asymmetric dimethylarginine) and VEGF (vascular endothelial growth factor) will be measured in plasma using ELISA kits
measure: Cardiovascular risk biomarkers
time frame: Week 16 (end of intervention)
description: PAI-1 (plasminogen activator inhibitor-1), ADMA (asymmetric dimethylarginine) and VEGF (vascular endothelial growth factor) will be measured in plasma using ELISA kits
measure: Inflammation biomarkers
time frame: Week 0 (baseline)
description: TNF-α (tumour necrosis factor-alpha), IL-6 (interleukin 6), C-reactive protein, serum A-amyloid, leptin, adiponectin, chemerin will be measured by ELISA kits
measure: Inflammation biomarkers
time frame: Week 16 (end of intervention)
description: TNF-α (tumour necrosis factor-alpha), IL-6 (interleukin 6), C-reactive protein, serum A-amyloid, leptin, adiponectin, chemerin will be measured in plasma by ELISA kits
measure: Satiety and eating behavior traits
time frame: Week 0 (baseline)
description: Satiety will be also estimated by using a VAS (visual analogue scale) questionnaire and eating behavior traits will be also evaluated with validated questionnaires
measure: Satiety and eating behavior traits
time frame: Week 16 (end of intervention)
description: Satiety will be also estimated by using a VAS (visual analogue scale) questionnaire and eating behavior traits will be also evaluated with validated questionnaires
measure: Plasma adipokines and myo-kines
time frame: Week 0 (baseline)
description: CT-1, irisin, FGF21 (fibroblast growth factor 21) and meteorin-like will be measured using ELISA kits
measure: Plasma adipokines and myo-kines
time frame: Week 16 (end of intervention)
description: CT-1, irisin, FGF21 (fibroblast growth factor 21) and meteorin-like will be measured using ELISA kits
measure: Plasma lipids and bioactive lipid mediators
time frame: Week 0 (baseline)
description: Lipidomic profile will be measured using targeted metabolomic-lipidomics by HPLC-MS (high pressure liquid chromatography-mass spectrometry).
measure: Plasma lipids and bioactive lipid mediators
time frame: Week 16 (end of intervention)
description: Lipidomic profile will be measured using targeted metabolomic-lipidomics by HPLC-MS (high pressure liquid chromatography-mass spectrometry).
measure: Adipose tissue gene profiling
time frame: Week 0 (baseline)
description: A biopsy (2 g) of subcutaneous abdominal periumbilical area adipose tissue will be obtained by liposuction under local anesthesia. RNA expression will be measured by RNA-seq or GeneChip Human Gene 2.1 ST Array (Affymetrix).
measure: Adipose tissue gene profiling
time frame: Week 16 (end of intervention)
description: A biopsy (2 g) of subcutaneous abdominal periumbilical area adipose tissue will be obtained by liposuction under local anesthesia. RNA expression will be measured by RNA-seq or GeneChip Human Gene 2.1 ST Array (Affymetrix).
measure: Adipose tissue miRNA profiling
time frame: Week 0 (baseline)
description: MiRNA expression will be measured by RNA-seq or GeneChip miRNA 4.0 Array (Affymetrix) in subcutaneous abdominal adipose tissue biopsies.
measure: Adipose tissue miRNA profiling
time frame: Week 16 (end of intervention)
description: MiRNA expression will be measured by RNA-seq or GeneChip miRNA 4.0 Array (Affymetrix) in subcutaneous abdominal adipose tissue biopsies.
measure: Bioactive lipid mediators involved in inflammation in adipose tissue
time frame: Week 0 (baseline)
description: Lipidomic profile will be measured using targeted metabolomic-lipidomics by HPLC-MS
measure: Bioactive lipid mediators involved in inflammation in adipose tissue
time frame: Week 16 (end of intervention)
description: Lipidomic profile will be measured using targeted metabolomic-lipidomics by HPLC-MS
measure: Determination of telomeres length
time frame: Week 0 (baseline)
description: Telomeres length will be measured in genomic DNA extracted from human peripheral blood and adipose tissue samples with a real-time quantitative PCR (polymerase chain reaction) approach.
measure: Determination of telomeres length
time frame: Week 16 (end of intervention)
description: Telomeres length will be measured in genomic DNA extracted from human peripheral blood and adipose tissue samples with a real-time quantitative PCR (polymerase chain reaction) approach.
measure: Characterization of gut microbiota
time frame: Week 0 (baseline)
description: Feces will collected and gut microbiota profiling will be carried out by high-throughput 16S (Svedberg units) rDNA (ribosomal deoxyribonucleic acid) amplicon sequencing approach.
measure: Characterization of gut microbiota
time frame: Week 16 (end of intervention)
description: Feces will collected and gut microbiota profiling will be carried out by high-throughput 16S (Svedberg units) rDNA (ribosomal deoxyribonucleic acid) amplicon sequencing approach.
measure: Urine metabolomic profile
time frame: Week 0 (baseline)
description: Urine will be collected and urinary metabolomic profile will be also evaluated by a HPLC-MS approach.
measure: Urine metabolomic profile
time frame: Week 16 (end of intervention)
description: Urine will be collected and urinary metabolomic profile will be also evaluated by a HPLC-MS approach.
arm group label: Control
arm group type: Placebo Comparator
description: Dietary advice for a healthy diet supplemented with placebo (olive oil).
arm group label: Omega-3
arm group type: Experimental
description: Dietary advice for a healthy diet supplemented with DHA-rich dietary supplement (providing 1.650 mg/day of DHA).
arm group label: Resistance Training
arm group type: Experimental
description: Dietary advice for a healthy diet supplemented with placebo (olive oil) and moderate resistance training program.
arm group label: Omega-3 + Resistance Training
arm group type: Experimental
description: Dietary advice for a healthy diet supplemented with a DHA-rich dietary supplement (providing 1.650 mg/day of DHA) and moderate resistance training program.
intervention type: Dietary Supplement
intervention name: Omega-3 (DHA-rich dietary supplement)
description: Double-blind randomized placebo-controlled intervention with DHA-rich dietary supplement with or without resistance training program for 16 weeks.
arm group label: Omega-3
arm group label: Omega-3 + Resistance Training
intervention type: Dietary Supplement
intervention name: Placebo (olive oil)
description: Double-blind randomized placebo-controlled intervention with DHA-rich dietary supplement with or without resistance training program for 16 weeks.
arm group label: Control
arm group label: Resistance Training
intervention type: Other
intervention name: Resistance training
description: Double-blind randomized placebo-controlled intervention with DHA-rich dietary supplement with or without resistance training program for 16 weeks.
arm group label: Omega-3 + Resistance Training
arm group label: Resistance Training
criteria: 
gender: Female
minimum age: 55 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: María J Moreno-Aliaga, PhD
role: Principal Investigator
affiliation: University of Navarra
last name: Silvia Lorente-Cebrián, PhD
role: Principal Investigator
affiliation: University of Navarra
facility: 
country: Spain
url: http://www.unav.edu/web/centro-de-investigacion-en-nutricion
description: Centre for Nutrition Research. University of Navarra
citation: Martinez-Fernandez L, Gonzalez-Muniesa P, Laiglesia LM, Sainz N, Prieto-Hontoria PL, Escote X, Odriozola L, Corrales FJ, Arbones-Mainar JM, Martinez JA, Moreno-Aliaga MJ. Maresin 1 improves insulin sensitivity and attenuates adipose tissue inflammation in ob/ob and diet-induced obese mice. FASEB J. 2017 May;31(5):2135-2145. doi: 10.1096/fj.201600859R. Epub 2017 Feb 10.
PMID: 28188173
citation: Lopez-Yoldi M, Stanhope KL, Garaulet M, Chen XG, Marcos-Gomez B, Carrasco-Benso MP, Santa Maria EM, Escote X, Lee V, Nunez MV, Medici V, Martinez-Anso E, Sainz N, Huerta AE, Laiglesia LM, Prieto J, Martinez JA, Bustos M, Havel PJ, Moreno-Aliaga MJ. Role of cardiotrophin-1 in the regulation of metabolic circadian rhythms and adipose core clock genes in mice and characterization of 24-h circulating CT-1 profiles in normal-weight and overweight/obese subjects. FASEB J. 2017 Apr;31(4):1639-1649. doi: 10.1096/fj.201600396RR. Epub 2017 Jan 17.
PMID: 28096235
citation: Laiglesia LM, Lorente-Cebrian S, Prieto-Hontoria PL, Fernandez-Galilea M, Ribeiro SM, Sainz N, Martinez JA, Moreno-Aliaga MJ. Eicosapentaenoic acid promotes mitochondrial biogenesis and beige-like features in subcutaneous adipocytes from overweight subjects. J Nutr Biochem. 2016 Nov;37:76-82. doi: 10.1016/j.jnutbio.2016.07.019. Epub 2016 Aug 26.
PMID: 27637001
citation: Huerta AE, Prieto-Hontoria PL, Fernandez-Galilea M, Escote X, Martinez JA, Moreno-Aliaga MJ. Effects of dietary supplementation with EPA and/or alpha-lipoic acid on adipose tissue transcriptomic profile of healthy overweight/obese women following a hypocaloric diet. Biofactors. 2017 Jan 2;43(1):117-131. doi: 10.1002/biof.1317. Epub 2016 Aug 10.
PMID: 27507611
citation: Huerta AE, Prieto-Hontoria PL, Sainz N, Martinez JA, Moreno-Aliaga MJ. Supplementation with alpha-Lipoic Acid Alone or in Combination with Eicosapentaenoic Acid Modulates the Inflammatory Status of Healthy Overweight or Obese Women Consuming an Energy-Restricted Diet. J Nutr. 2015 Apr 1;146(4):889S-896S. doi: 10.3945/jn.115.224105.
PMID: 26962183
citation: Milagro FI, Moreno-Aliaga MJ, Martinez JA. FTO Obesity Variant and Adipocyte Browning in Humans. N Engl J Med. 2016 Jan 14;374(2):190-1. doi: 10.1056/NEJMc1513316. No abstract available.
PMID: 26760097
citation: Prieto-Hontoria PL, Perez-Matute P, Fernandez-Galilea M, Lopez-Yoldi M, Sinal CJ, Martinez JA, Moreno-Aliaga MJ. Effects of alpha-lipoic acid on chemerin secretion in 3T3-L1 and human adipocytes. Biochim Biophys Acta. 2016 Mar;1861(3):260-8. doi: 10.1016/j.bbalip.2015.12.011. Epub 2015 Dec 22.
PMID: 26721419
citation: Martinez-Fernandez L, Laiglesia LM, Huerta AE, Martinez JA, Moreno-Aliaga MJ. Omega-3 fatty acids and adipose tissue function in obesity and metabolic syndrome. Prostaglandins Other Lipid Mediat. 2015 Sep;121(Pt A):24-41. doi: 10.1016/j.prostaglandins.2015.07.003. Epub 2015 Jul 26.
PMID: 26219838
citation: Mansego ML, Milagro FI, Zulet MA, Moreno-Aliaga MJ, Martinez JA. Differential DNA Methylation in Relation to Age and Health Risks of Obesity. Int J Mol Sci. 2015 Jul 24;16(8):16816-32. doi: 10.3390/ijms160816816.
PMID: 26213922
citation: Huerta AE, Prieto-Hontoria PL, Fernandez-Galilea M, Sainz N, Cuervo M, Martinez JA, Moreno-Aliaga MJ. Circulating irisin and glucose metabolism in overweight/obese women: effects of alpha-lipoic acid and eicosapentaenoic acid. J Physiol Biochem. 2015 Sep;71(3):547-58. doi: 10.1007/s13105-015-0400-5. Epub 2015 Mar 28.
PMID: 25820474
citation: Lorente-Cebrian S, Costa AG, Navas-Carretero S, Zabala M, Laiglesia LM, Martinez JA, Moreno-Aliaga MJ. An update on the role of omega-3 fatty acids on inflammatory and degenerative diseases. J Physiol Biochem. 2015 Jun;71(2):341-9. doi: 10.1007/s13105-015-0395-y. Epub 2015 Mar 11.
PMID: 25752887
citation: Huerta AE, Navas-Carretero S, Prieto-Hontoria PL, Martinez JA, Moreno-Aliaga MJ. Effects of alpha-lipoic acid and eicosapentaenoic acid in overweight and obese women during weight loss. Obesity (Silver Spring). 2015 Feb;23(2):313-21. doi: 10.1002/oby.20966. Epub 2014 Dec 31.
PMID: 25594166
citation: Gonzalez-Muniesa P, Marrades MP, Martinez JA, Moreno-Aliaga MJ. Differential proinflammatory and oxidative stress response and vulnerability to metabolic syndrome in habitual high-fat young male consumers putatively predisposed by their genetic background. Int J Mol Sci. 2013 Aug 22;14(9):17238-55. doi: 10.3390/ijms140917238.
PMID: 23975165
citation: Lorente-Cebrian S, Costa AG, Navas-Carretero S, Zabala M, Martinez JA, Moreno-Aliaga MJ. Role of omega-3 fatty acids in obesity, metabolic syndrome, and cardiovascular diseases: a review of the evidence. J Physiol Biochem. 2013 Sep;69(3):633-51. doi: 10.1007/s13105-013-0265-4. Epub 2013 Jun 22.
PMID: 23794360
citation: Lorente-Cebrian S, Bustos M, Marti A, Fernandez-Galilea M, Martinez JA, Moreno-Aliaga MJ. Eicosapentaenoic acid inhibits tumour necrosis factor-alpha-induced lipolysis in murine cultured adipocytes. J Nutr Biochem. 2012 Mar;23(3):218-27. doi: 10.1016/j.jnutbio.2010.11.018. Epub 2011 Apr 14.
PMID: 21497077
citation: Marrades MP, Gonzalez-Muniesa P, Martinez JA, Moreno-Aliaga MJ. A dysregulation in CES1, APOE and other lipid metabolism-related genes is associated to cardiovascular risk factors linked to obesity. Obes Facts. 2010 Oct;3(5):312-8. doi: 10.1159/000321451. Epub 2010 Oct 15.
PMID: 20975297
citation: Marrades MP, Gonzalez-Muniesa P, Arteta D, Martinez JA, Moreno-Aliaga MJ. Orchestrated downregulation of genes involved in oxidative metabolic pathways in obese vs. lean high-fat young male consumers. J Physiol Biochem. 2011 Mar;67(1):15-26. doi: 10.1007/s13105-010-0044-4. Epub 2010 Sep 30.
PMID: 20882379
citation: Moreno-Aliaga MJ, Lorente-Cebrian S, Martinez JA. Regulation of adipokine secretion by n-3 fatty acids. Proc Nutr Soc. 2010 Aug;69(3):324-32. doi: 10.1017/S0029665110001801. Epub 2010 Jun 14.
PMID: 20540825
citation: Lorente-Cebrian S, Bustos M, Marti A, Martinez JA, Moreno-Aliaga MJ. Eicosapentaenoic acid up-regulates apelin secretion and gene expression in 3T3-L1 adipocytes. Mol Nutr Food Res. 2010 May;54 Suppl 1:S104-11. doi: 10.1002/mnfr.200900522.
PMID: 20352620
citation: Lorente-Cebrian S, Bustos M, Marti A, Martinez JA, Moreno-Aliaga MJ. Eicosapentaenoic acid stimulates AMP-activated protein kinase and increases visfatin secretion in cultured murine adipocytes. Clin Sci (Lond). 2009 Aug 14;117(6):243-9. doi: 10.1042/CS20090020.
PMID: 19296827
citation: Perez-Echarri N, Perez-Matute P, Marcos-Gomez B, Marti A, Martinez JA, Moreno-Aliaga MJ. Down-regulation in muscle and liver lipogenic genes: EPA ethyl ester treatment in lean and overweight (high-fat-fed) rats. J Nutr Biochem. 2009 Sep;20(9):705-14. doi: 10.1016/j.jnutbio.2008.06.013. Epub 2008 Sep 30.
PMID: 18829285
responsible party type: Sponsor
mesh term: Obesity
mesh term: Inflammation
sharing ipd: No