<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/NCT02194504</url>
  </required_header>
  <id_info>
    <org_study_id>NL44614.081.13</org_study_id>
    <nct_id>NCT02194504</nct_id>
  </id_info>
  <brief_title>The Belly Fat Study: Nutritional Intervention to Improve Metabolic Health in Subjects With Increased Abdominal Adiposity</brief_title>
  <official_title>The Belly Fat Study: Nutritional Intervention to Improve Metabolic Health in Subjects With Increased Abdominal Adiposity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wageningen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wageningen University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In the Belly Fat study, the effects of two different caloric-restricted diets on metabolic&#xD;
      health will be examined in male and female subjects with increased abdominal adiposity (BMI&#xD;
      &gt;27 kg/m2). Metabolic health is defined as health of the primary metabolic organs the liver,&#xD;
      gut and the adipose tissue, examined in a static state as well as after the application of a&#xD;
      challenge test.&#xD;
&#xD;
      The diets are equally caloric-restricted, but differ in nutrient composition. It is&#xD;
      hypothesized that one of the two diets causes a larger improvement in organ health and&#xD;
      reduction in liver fat.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rationale: It is known that in particular visceral fat (abdominal obesity) and fat deposition&#xD;
      in non-adipose tissue such as the liver are important factors related to metabolic health,&#xD;
      such as the degree of insulin resistance, dyslipidaemia and other well-established&#xD;
      cardio-metabolic risk factors. The arise of pathological consequences of abdominal obesity&#xD;
      are a result of a disturbance in the elegant interplay between metabolic organs, such as the&#xD;
      liver, adipose tissue and gut. Several nutrients have demonstrated to exert positive or&#xD;
      negative effects on the health and functioning of metabolic organs. A diet (whole dietary&#xD;
      approach) can thus be a power tool to improve the health status of individuals with abdominal&#xD;
      obesity by improving organ health.&#xD;
&#xD;
      Objective: The primary objective of this study is to compare the effects of two different&#xD;
      diets on the static metabolic health status as assessed by determination of organ health and,&#xD;
      more specifically, of lipid accumulation in the liver. The application of a mixed meal&#xD;
      challenge test will be used to gain insight in the dynamic metabolic health status. A&#xD;
      secondary objective is to determine the reaction (brain activity) of individuals with&#xD;
      abdominal obesity after visual and olfactory food-cues.&#xD;
&#xD;
      Study design and intervention: Randomized, parallel design consisting of three groups:&#xD;
&#xD;
        1. 40 subjects, 12-wk nutritional intervention based on dietary advice: diet with 30%&#xD;
           caloric restriction and a Western style nutrient composition&#xD;
&#xD;
        2. 40 subjects, 12-wk nutritional intervention based on dietary advice: diet with 30%&#xD;
           caloric restriction with a nutrient composition aimed at improving organ health and&#xD;
           reducing liver fat&#xD;
&#xD;
        3. 30 subjects, control group, no nutritional intervention (optional: dietary advice at the&#xD;
           end of the study period)&#xD;
&#xD;
      Measurements on metabolic health will be conducted at baseline and after 12-wk intervention&#xD;
      and include:&#xD;
&#xD;
        -  MR imaging for determining body fat distribution&#xD;
&#xD;
        -  MR spectroscopy for quantification of liver fat&#xD;
&#xD;
        -  Blood sampling (plasma and PBMCs) before and several timepoints after mixed meal&#xD;
           challenge&#xD;
&#xD;
        -  Adipose tissue sampling before and after mixed meal challenge&#xD;
&#xD;
        -  Vascular measurements before and after mixed meal challenge&#xD;
&#xD;
        -  Urine and feces sampling&#xD;
&#xD;
      Study population: Males and females, 40-70 yrs old, BMI &gt; 27 kg/m2&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intrahepatic lipid accumulation (IHL)</measure>
    <time_frame>Baseline and after 12-wk intervention</time_frame>
    <description>Assessment of IHL by means of 1H-MRS (magnetic resonance spectroscopy)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body fat distribution</measure>
    <time_frame>Baseline and after 12-wk intervention</time_frame>
    <description>Assessment of body fat distribution (SAT/VAT) by means of MRI (magnetic resonance imaging)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adipose tissue gene expression before and 4h after a mixed meal challenge</measure>
    <time_frame>Baseline and after 12-wk intervention</time_frame>
    <description>Micro-array/qPCR</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Markers of liver health (plasma) before and after mixed meal challenge</measure>
    <time_frame>Baseline and after 12-wk intervention</time_frame>
    <description>Liver enzymes</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cardio-metabolic risk factors (plasma) before and after mixed meal challenge</measure>
    <time_frame>Baseline and after 12-wk intervention</time_frame>
    <description>Insulin, glucose, Tg</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Inflammatory markers (plasma) before and after mixed meal challenge</measure>
    <time_frame>Baseline and after 12-wk intervention</time_frame>
    <description>Cytokines</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Markers of adipose tissue health (plasma)</measure>
    <time_frame>Baseline and after 12-wk intervention</time_frame>
    <description>Adipokines</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Markers of gut health (plasma)</measure>
    <time_frame>Baseline and after 12-wk intervention</time_frame>
    <description>Gut hormones</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Microbiota (faeces)</measure>
    <time_frame>Baseline and after 12-wk intervention</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Urinary metabolites</measure>
    <time_frame>Baseline and after 12-wk intervention</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>PBMC gene expression profile</measure>
    <time_frame>Baseline and after 12-wk intervention</time_frame>
    <description>Micro-array/qPCR</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vascular functions (blood pressure and arterial stiffness) before and after mixed meal challenge</measure>
    <time_frame>Baseline and after 12-wk intervention</time_frame>
    <description>PWA</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Satiety and wellbeing before and after mixed meal challenge</measure>
    <time_frame>Baseline and after 12-wk intervention</time_frame>
    <description>Assessment by validated questionnaires</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">110</enrollment>
  <condition>Abdominal Obesity</condition>
  <condition>Liver Fat</condition>
  <arm_group>
    <arm_group_label>No dietary advice</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No dietary intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dietary advice, Targeted</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>12-wk dietary advice</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dietary advice, Western</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>12-wk dietary advice</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dietary advice, Western</intervention_name>
    <description>Dietary advice, guided by professional dieticians. Caloric restricted (-30en%) diet with Western type nutrient composition (SFA, carbohydrates, sugars, fruit juice, meat, dairy)</description>
    <arm_group_label>Dietary advice, Western</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dietary advice, Targeted</intervention_name>
    <description>Dietary advice, guided by professional dieticians. Caloric restricted (-30en%) diet with nutrient composition aiming at an improvement in organ health and a reduction in liver fat (PUFA, fish, soy protein, whole grain)</description>
    <arm_group_label>Dietary advice, Targeted</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 40-70y at the time of recruitment&#xD;
&#xD;
          -  BMI &gt;27kg/m2 or waist circumference &gt;102cm (males) or &gt;88cm (females)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diabetic (normoglycemic according to WHO criteria (OGTT, fasting blood glucose&lt; 7&#xD;
             mmol/L, after 2 hr &lt;11.1 mmol/L)&#xD;
&#xD;
          -  Daily intake of alcohol of &gt;30g (men) or &gt;20g (women)&#xD;
&#xD;
          -  Tobacco smoker&#xD;
&#xD;
          -  Abuse of drugs&#xD;
&#xD;
          -  Any medical conditions or (metal) devices interfering with or posing a risk for the&#xD;
             participant in 1H-MRS/MRI scanning (e.g. claustrophobia, pace maker, surgical&#xD;
             screws/pins, artificial joints or heart valves, etc.)&#xD;
&#xD;
          -  Diagnosed with any long-term medical condition (i.e. cardiovascular disease,&#xD;
             gastrointestinal disease, renal dysfunction)&#xD;
&#xD;
          -  Use of medications known to interfere with glucose or lipid homeostasis (i.e.&#xD;
             corticosteroids)&#xD;
&#xD;
          -  Allergic to fish oil or unwilling to consume fish oil supplements&#xD;
&#xD;
          -  Unwilling to comply with dietary guidelines&#xD;
&#xD;
          -  Restricted to a vegetarian dietary regime&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>L Afman, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wageningen University. Department Human Nutrition. Nutrition, Metabolism &amp; Genomics Group</affiliation>
  </overall_official>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 18, 2014</study_first_posted>
  <last_update_submitted>April 16, 2015</last_update_submitted>
  <last_update_submitted_qc>April 16, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 17, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Metabolic health</keyword>
  <keyword>Phenotyping</keyword>
  <keyword>Abdominal obesity</keyword>
  <keyword>Abdominal adiposity</keyword>
  <keyword>Liver fat</keyword>
  <keyword>Belly fat</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Obesity, Abdominal</mesh_term>
  </condition_browse>
  <!-- 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/NCT02194504
org study id: NL44614.081.13
nct id: NCT02194504
lead sponsor: 
has dmc: No
In the Belly Fat study, the effects of two different caloric-restricted diets on metabolic
      health will be examined in male and female subjects with increased abdominal adiposity (BMI
      >27 kg/m2). Metabolic health is defined as health of the primary metabolic organs the liver,
      gut and the adipose tissue, examined in a static state as well as after the application of a
      challenge test.

      The diets are equally caloric-restricted, but differ in nutrient composition. It is
      hypothesized that one of the two diets causes a larger improvement in organ health and
      reduction in liver fat.
Rationale: It is known that in particular visceral fat (abdominal obesity) and fat deposition
      in non-adipose tissue such as the liver are important factors related to metabolic health,
      such as the degree of insulin resistance, dyslipidaemia and other well-established
      cardio-metabolic risk factors. The arise of pathological consequences of abdominal obesity
      are a result of a disturbance in the elegant interplay between metabolic organs, such as the
      liver, adipose tissue and gut. Several nutrients have demonstrated to exert positive or
      negative effects on the health and functioning of metabolic organs. A diet (whole dietary
      approach) can thus be a power tool to improve the health status of individuals with abdominal
      obesity by improving organ health.

      Objective: The primary objective of this study is to compare the effects of two different
      diets on the static metabolic health status as assessed by determination of organ health and,
      more specifically, of lipid accumulation in the liver. The application of a mixed meal
      challenge test will be used to gain insight in the dynamic metabolic health status. A
      secondary objective is to determine the reaction (brain activity) of individuals with
      abdominal obesity after visual and olfactory food-cues.

      Study design and intervention: Randomized, parallel design consisting of three groups:

        1. 40 subjects, 12-wk nutritional intervention based on dietary advice: diet with 30%
           caloric restriction and a Western style nutrient composition

        2. 40 subjects, 12-wk nutritional intervention based on dietary advice: diet with 30%
           caloric restriction with a nutrient composition aimed at improving organ health and
           reducing liver fat

        3. 30 subjects, control group, no nutritional intervention (optional: dietary advice at the
           end of the study period)

      Measurements on metabolic health will be conducted at baseline and after 12-wk intervention
      and include:

        -  MR imaging for determining body fat distribution

        -  MR spectroscopy for quantification of liver fat

        -  Blood sampling (plasma and PBMCs) before and several timepoints after mixed meal
           challenge

        -  Adipose tissue sampling before and after mixed meal challenge

        -  Vascular measurements before and after mixed meal challenge

        -  Urine and feces sampling

      Study population: Males and females, 40-70 yrs old, BMI > 27 kg/m2
allocation: Randomized
intervention model: Parallel Assignment
masking: None (Open Label)
measure: Intrahepatic lipid accumulation (IHL)
time frame: Baseline and after 12-wk intervention
description: Assessment of IHL by means of 1H-MRS (magnetic resonance spectroscopy)
measure: Body fat distribution
time frame: Baseline and after 12-wk intervention
description: Assessment of body fat distribution (SAT/VAT) by means of MRI (magnetic resonance imaging)
measure: Adipose tissue gene expression before and 4h after a mixed meal challenge
time frame: Baseline and after 12-wk intervention
description: Micro-array/qPCR
measure: Markers of liver health (plasma) before and after mixed meal challenge
time frame: Baseline and after 12-wk intervention
description: Liver enzymes
measure: Cardio-metabolic risk factors (plasma) before and after mixed meal challenge
time frame: Baseline and after 12-wk intervention
description: Insulin, glucose, Tg
measure: Inflammatory markers (plasma) before and after mixed meal challenge
time frame: Baseline and after 12-wk intervention
description: Cytokines
measure: Markers of adipose tissue health (plasma)
time frame: Baseline and after 12-wk intervention
description: Adipokines
measure: Markers of gut health (plasma)
time frame: Baseline and after 12-wk intervention
description: Gut hormones
measure: Microbiota (faeces)
time frame: Baseline and after 12-wk intervention
measure: Urinary metabolites
time frame: Baseline and after 12-wk intervention
measure: PBMC gene expression profile
time frame: Baseline and after 12-wk intervention
description: Micro-array/qPCR
measure: Vascular functions (blood pressure and arterial stiffness) before and after mixed meal challenge
time frame: Baseline and after 12-wk intervention
description: PWA
measure: Satiety and wellbeing before and after mixed meal challenge
time frame: Baseline and after 12-wk intervention
description: Assessment by validated questionnaires
arm group label: No dietary advice
arm group type: No Intervention
description: No dietary intervention
arm group label: Dietary advice, Targeted
arm group type: Experimental
description: 12-wk dietary advice
arm group label: Dietary advice, Western
arm group type: Experimental
description: 12-wk dietary advice
intervention type: Other
intervention name: Dietary advice, Western
description: Dietary advice, guided by professional dieticians. Caloric restricted (-30en%) diet with Western type nutrient composition (SFA, carbohydrates, sugars, fruit juice, meat, dairy)
arm group label: Dietary advice, Western
intervention type: Other
intervention name: Dietary advice, Targeted
description: Dietary advice, guided by professional dieticians. Caloric restricted (-30en%) diet with nutrient composition aiming at an improvement in organ health and a reduction in liver fat (PUFA, fish, soy protein, whole grain)
arm group label: Dietary advice, Targeted
criteria: 
gender: All
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: L Afman, PhD
role: Principal Investigator
affiliation: Wageningen University. Department Human Nutrition. Nutrition, Metabolism & Genomics Group
responsible party type: Sponsor
mesh term: Obesity
mesh term: Obesity, Abdominal