<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/NCT04402697</url>
  </required_header>
  <id_info>
    <org_study_id>nºIB 3216/16 PI</org_study_id>
    <nct_id>NCT04402697</nct_id>
  </id_info>
  <brief_title>Analysis of Metabolic State in Normal-weight and Overweight-obese After Lifestyle Improvement and/or Weight Loss</brief_title>
  <acronym>METAHEALTH</acronym>
  <official_title>Study of the Usefulness of Blood Cells for the Analysis of Metabolic Recovery After Weight Loss (METAHEALTH-TEST)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of the Balearic Islands</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of the Balearic Islands</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>
      The aim of this study is to design and validate a test, METAHEALTH-TEST, based in gene&#xD;
      expression analysis in blood cells, to quickly and easily analyse metabolic health. This test&#xD;
      will be used to analyse metabolic improvement in overweight/obese individuals and in&#xD;
      metabolically obese normal-weight (MONW) individuals after undergoing a weight loss&#xD;
      intervention and/or an intervention for improvement in eating habits and lifestyle.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 25, 2016</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">December 31, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Volunteers are assigned to three groups for the duration of the study:&#xD;
Normal-weight&#xD;
Overweight-Obese&#xD;
Metabolically obese normal-weight</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of individuals responding to fasting assessed by changes in gene expression profile of blood cells</measure>
    <time_frame>Baseline point (all groups)</time_frame>
    <description>The effect of fasting on gene expression profile of blood cells will be analyzed by real-time RT-qPCR and microarray</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of individuals responding to fasting assessed by changes in gene expression profile of blood cells</measure>
    <time_frame>3 months (OW-OB and MONW groups)</time_frame>
    <description>The effect of fasting on gene expression profile of blood cells will be analyzed by real-time RT-qPCR and microarray</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of individuals responding to fasting assessed by changes in gene expression profile of blood cells</measure>
    <time_frame>6 months (OW-OB and MONW groups)</time_frame>
    <description>The effect of fasting on gene expression profile of blood cells will be analyzed by real-time RT-qPCR and microarray</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Weight</measure>
    <time_frame>Baseline point (all groups)</time_frame>
    <description>Weight (kg)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Weight</measure>
    <time_frame>3 months (OW-OB and MONW groups)</time_frame>
    <description>Weight (kg)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Weight</measure>
    <time_frame>6 months (OW-OB and MONW groups)</time_frame>
    <description>Weight (kg)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body Mass Index (BMI)</measure>
    <time_frame>Baseline point (all groups)</time_frame>
    <description>Weight and height will be combined to report BMI in kg/m^2).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body Mass Index (BMI)</measure>
    <time_frame>3 months (OW-OB and MONW groups)</time_frame>
    <description>Weight and height will be combined to report BMI in kg/m^2).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body Mass Index (BMI)</measure>
    <time_frame>6 months (OW-OB and MONW groups)</time_frame>
    <description>Weight and height will be combined to report BMI in kg/m^2).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body composition</measure>
    <time_frame>Baseline point (all groups)</time_frame>
    <description>Body composition (fat mass in kg) measured using a DXA scanner</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body composition</measure>
    <time_frame>3 months (OW-OB and MONW groups)</time_frame>
    <description>Body composition (fat mass in kg) measured using a DXA scanner</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body composition</measure>
    <time_frame>6 months (OW-OB and MONW groups)</time_frame>
    <description>Body composition (fat mass in kg) measured using a DXA scanner</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Circulating glucose, triglycerides (TG), total cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and C-reactive protein (CRP)</measure>
    <time_frame>Baseline point (all groups)</time_frame>
    <description>Circulating parameters measured in mg/dL</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Circulating glucose, triglycerides (TG), total cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and C-reactive protein (CRP)</measure>
    <time_frame>3 months (OW-OB and MONW groups)</time_frame>
    <description>Circulating parameters measured in mg/dL</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Circulating glucose, triglycerides (TG), total cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and C-reactive protein (CRP)</measure>
    <time_frame>6 months (OW-OB and MONW groups)</time_frame>
    <description>Circulating parameters measured in mg/dL</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Circulating gamma-glutamyl transpeptidase (GGT)</measure>
    <time_frame>Baseline point (all groups)</time_frame>
    <description>GGT measured in U/L</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Circulating gamma-glutamyl transpeptidase (GGT)</measure>
    <time_frame>3 months (OW-OB and MONW groups)</time_frame>
    <description>GGT measured in U/L</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Circulating gamma-glutamyl transpeptidase (GGT)</measure>
    <time_frame>6 months (OW-OB and MONW groups)</time_frame>
    <description>GGT measured in U/L</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Height</measure>
    <time_frame>Baseline point (all groups)</time_frame>
    <description>Height (m)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Height</measure>
    <time_frame>3 months (OW-OB and MONW groups)</time_frame>
    <description>Height (m)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Height</measure>
    <time_frame>6 months (OW-OB and MONW groups)</time_frame>
    <description>Height (m)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist-hip ratio</measure>
    <time_frame>Baseline point (all groups)</time_frame>
    <description>Waist-hip ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist-hip ratio</measure>
    <time_frame>3 months (OW-OB and MONW groups)</time_frame>
    <description>Waist-hip ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist-hip ratio</measure>
    <time_frame>6 months (OW-OB and MONW groups)</time_frame>
    <description>Waist-hip ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>Baseline point (all groups)</time_frame>
    <description>Blood pressure (mm Hg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>3 months (OW-OB and MONW groups)</time_frame>
    <description>Blood pressure (mm Hg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>6 months (OW-OB and MONW groups)</time_frame>
    <description>Blood pressure (mm Hg)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Overweight and Obesity</condition>
  <arm_group>
    <arm_group_label>Normal-weight (NW)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Individuals with BMI&lt;25 kg/m2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Overweight-Obese (OW-OB)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Individuals with BMI&gt;25 kg/m2, submitted to a nutritional intervention (hypocaloric balanced diet) during 6 months and prescription of physical activity to achieve weigh loss</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Metabolically obese normal-weight (MONW)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Individuals with BMI&lt;25 kg/m2, with metabolic alterations related to obesity (hypertriglyceridemia, hypercholesterolemia, hyperglycaemia, hypertension or high waist-hip ratio), submitted to an intervention to improve dietary habits and physical activity in order to achieve a better body composition and metabolic health. Mediterranean diet will be and aerobic and strength exercises will be advised to these individuals.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dietary and physical activity intervention</intervention_name>
    <description>OW-OB group: 6-month program of weight loss consisting in a low-calorie food plan (30% reduction in the individual energy requirements) with dietary sessions and exercise counselling.&#xD;
MONW group: 6-month program to improve eating habits (Mediterranean diet) with dietary sessions and exercise counselling.</description>
    <arm_group_label>Metabolically obese normal-weight (MONW)</arm_group_label>
    <arm_group_label>Overweight-Obese (OW-OB)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 18-45 years&#xD;
&#xD;
          -  Participants with no chronic disease (excluding those related to overweight/obesity)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Minors or older than 45 years&#xD;
&#xD;
          -  Presence of a metabolic illness&#xD;
&#xD;
          -  Intake of regular medication or drugs&#xD;
&#xD;
          -  Precedents of alcohol or drug consumption&#xD;
&#xD;
          -  Physic of psychic disability&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of the Balearic Islands</name>
      <address>
        <city>Palma De Mallorca</city>
        <state>Balearic Islands</state>
        <zip>07122</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>May 13, 2020</study_first_submitted>
  <study_first_submitted_qc>May 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>July 28, 2022</last_update_submitted>
  <last_update_submitted_qc>July 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Overweight</keyword>
  <keyword>Obesity</keyword>
  <keyword>Blood cells</keyword>
  <keyword>Metabolic health</keyword>
  <keyword>Weight loss</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Weight Loss</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>IPD will be shared in due time if considered relevant for other research. With our current objectives, it is not considered necessary.</ipd_description>
  </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/NCT04402697
org study id: nºIB 3216/16 PI
nct id: NCT04402697
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to design and validate a test, METAHEALTH-TEST, based in gene
      expression analysis in blood cells, to quickly and easily analyse metabolic health. This test
      will be used to analyse metabolic improvement in overweight/obese individuals and in
      metabolically obese normal-weight (MONW) individuals after undergoing a weight loss
      intervention and/or an intervention for improvement in eating habits and lifestyle.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Volunteers are assigned to three groups for the duration of the study:
Normal-weight
Overweight-Obese
Metabolically obese normal-weight
primary purpose: Prevention
masking: None (Open Label)
measure: Number of individuals responding to fasting assessed by changes in gene expression profile of blood cells
time frame: Baseline point (all groups)
description: The effect of fasting on gene expression profile of blood cells will be analyzed by real-time RT-qPCR and microarray
measure: Number of individuals responding to fasting assessed by changes in gene expression profile of blood cells
time frame: 3 months (OW-OB and MONW groups)
description: The effect of fasting on gene expression profile of blood cells will be analyzed by real-time RT-qPCR and microarray
measure: Number of individuals responding to fasting assessed by changes in gene expression profile of blood cells
time frame: 6 months (OW-OB and MONW groups)
description: The effect of fasting on gene expression profile of blood cells will be analyzed by real-time RT-qPCR and microarray
measure: Weight
time frame: Baseline point (all groups)
description: Weight (kg)
measure: Weight
time frame: 3 months (OW-OB and MONW groups)
description: Weight (kg)
measure: Weight
time frame: 6 months (OW-OB and MONW groups)
description: Weight (kg)
measure: Body Mass Index (BMI)
time frame: Baseline point (all groups)
description: Weight and height will be combined to report BMI in kg/m^2).
measure: Body Mass Index (BMI)
time frame: 3 months (OW-OB and MONW groups)
description: Weight and height will be combined to report BMI in kg/m^2).
measure: Body Mass Index (BMI)
time frame: 6 months (OW-OB and MONW groups)
description: Weight and height will be combined to report BMI in kg/m^2).
measure: Body composition
time frame: Baseline point (all groups)
description: Body composition (fat mass in kg) measured using a DXA scanner
measure: Body composition
time frame: 3 months (OW-OB and MONW groups)
description: Body composition (fat mass in kg) measured using a DXA scanner
measure: Body composition
time frame: 6 months (OW-OB and MONW groups)
description: Body composition (fat mass in kg) measured using a DXA scanner
measure: Circulating glucose, triglycerides (TG), total cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and C-reactive protein (CRP)
time frame: Baseline point (all groups)
description: Circulating parameters measured in mg/dL
measure: Circulating glucose, triglycerides (TG), total cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and C-reactive protein (CRP)
time frame: 3 months (OW-OB and MONW groups)
description: Circulating parameters measured in mg/dL
measure: Circulating glucose, triglycerides (TG), total cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and C-reactive protein (CRP)
time frame: 6 months (OW-OB and MONW groups)
description: Circulating parameters measured in mg/dL
measure: Circulating gamma-glutamyl transpeptidase (GGT)
time frame: Baseline point (all groups)
description: GGT measured in U/L
measure: Circulating gamma-glutamyl transpeptidase (GGT)
time frame: 3 months (OW-OB and MONW groups)
description: GGT measured in U/L
measure: Circulating gamma-glutamyl transpeptidase (GGT)
time frame: 6 months (OW-OB and MONW groups)
description: GGT measured in U/L
measure: Height
time frame: Baseline point (all groups)
description: Height (m)
measure: Height
time frame: 3 months (OW-OB and MONW groups)
description: Height (m)
measure: Height
time frame: 6 months (OW-OB and MONW groups)
description: Height (m)
measure: Waist-hip ratio
time frame: Baseline point (all groups)
description: Waist-hip ratio
measure: Waist-hip ratio
time frame: 3 months (OW-OB and MONW groups)
description: Waist-hip ratio
measure: Waist-hip ratio
time frame: 6 months (OW-OB and MONW groups)
description: Waist-hip ratio
measure: Blood pressure
time frame: Baseline point (all groups)
description: Blood pressure (mm Hg)
measure: Blood pressure
time frame: 3 months (OW-OB and MONW groups)
description: Blood pressure (mm Hg)
measure: Blood pressure
time frame: 6 months (OW-OB and MONW groups)
description: Blood pressure (mm Hg)
arm group label: Normal-weight (NW)
arm group type: No Intervention
description: Individuals with BMI<25 kg/m2
arm group label: Overweight-Obese (OW-OB)
arm group type: Experimental
description: Individuals with BMI>25 kg/m2, submitted to a nutritional intervention (hypocaloric balanced diet) during 6 months and prescription of physical activity to achieve weigh loss
arm group label: Metabolically obese normal-weight (MONW)
arm group type: Experimental
description: Individuals with BMI<25 kg/m2, with metabolic alterations related to obesity (hypertriglyceridemia, hypercholesterolemia, hyperglycaemia, hypertension or high waist-hip ratio), submitted to an intervention to improve dietary habits and physical activity in order to achieve a better body composition and metabolic health. Mediterranean diet will be and aerobic and strength exercises will be advised to these individuals.
intervention type: Other
intervention name: Dietary and physical activity intervention
description: OW-OB group: 6-month program of weight loss consisting in a low-calorie food plan (30% reduction in the individual energy requirements) with dietary sessions and exercise counselling.
MONW group: 6-month program to improve eating habits (Mediterranean diet) with dietary sessions and exercise counselling.
arm group label: Metabolically obese normal-weight (MONW)
arm group label: Overweight-Obese (OW-OB)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Overweight
mesh term: Weight Loss
sharing ipd: Undecided
ipd description: IPD will be shared in due time if considered relevant for other research. With our current objectives, it is not considered necessary.