<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/NCT02225457</url>
  </required_header>
  <id_info>
    <org_study_id>391/13</org_study_id>
    <secondary_id>SNF 320030_141065</secondary_id>
    <nct_id>NCT02225457</nct_id>
  </id_info>
  <brief_title>Study of the Mechanisms of Metabolic Adaptations to Overfeeding</brief_title>
  <acronym>Polynut</acronym>
  <official_title>Study of the Determinants and Mechanisms of Adaptation of Metabolic Responses to Controlled Overfeeding in Female and Male Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire Vaudois</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Lyon</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre Hospitalier Universitaire Vaudois</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Obesity results from complex interactions between genetic and environmental factors, and are&#xD;
      strongly associated with metabolic complications such as type 2 diabetes mellitus. Obesity is&#xD;
      defined as an excessive fat accumulation that presents a risk to health, a risk that is&#xD;
      highly dependent upon the type of adipose tissue accumulation, whether visceral or&#xD;
      sub-cutaneous, but also upon the characteristics of the fat tissue, especially inflammatory&#xD;
      cells accumulation. Because of the well known sexual difference in fat accretion, this&#xD;
      obesity-associated risk may also be very different for men and for women. In addition, recent&#xD;
      data indicate that various factors such as the intestinal microbiota, but also the dietary&#xD;
      intake of protective nutrients might be important determinants of the metabolic complications&#xD;
      of obesity.&#xD;
&#xD;
      Here we propose to: 1) study the metabolic adaptations and the mechanisms of adipose tissue&#xD;
      accumulation during a period of controlled caloric over-nutrition, both in men and in women;&#xD;
      2) evaluate the potential protective effects of a supplementation with polyphenols on insulin&#xD;
      resistance and other metabolic adaptations.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To achieve these goals, healthy male and female volunteers will be enrolled into a one month&#xD;
      longitudinal, prospective study on the influence of hypercaloric overfeeding (+50% of daily&#xD;
      caloric needs) on different tissues (adipose tissue, muscle and blood).&#xD;
&#xD;
      They will be separated into two different groups: hypercaloric nutrition and placebo, and&#xD;
      hypercaloric nutrition and polyphenols (2g/day), where polyphenols administration will be&#xD;
      randomized and administered in a double blind fashion. Whole body and hepatic insulin&#xD;
      sensitivity, total energy expenditure, glucose hepatic production, protein and gene&#xD;
      expression in muscle, adipose tissue and blood as well as intestinal microbiota will be&#xD;
      assessed at base line, and after one month of overfeeding.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2013</start_date>
  <completion_date type="Anticipated">January 2017</completion_date>
  <primary_completion_date type="Anticipated">May 2016</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>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in insulin sensitivity</measure>
    <time_frame>baseline, day 31 of overfeeding</time_frame>
    <description>Whole body insulin sensitivity will be measured during hyperinsulinemic, euglycemic clamps.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in muscle and adipose tissue gene expression</measure>
    <time_frame>Baseline, day 28 of overfeeding</time_frame>
    <description>Transcriptomic experiments will be performed on muscle and adipose tissue samples</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">52</enrollment>
  <condition>Obesity</condition>
  <condition>Diabetes</condition>
  <arm_group>
    <arm_group_label>Hypercaloric diet and polyphenols</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>polyphenols will consist in the administration of 1 gram (5x200 mg) of the compound bid during the entire overfeeding period.&#xD;
Hypercaloric diet will consist in a hypercaloric diet providing an excess of 50% KCal over daily requirements, and will last 30 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hypercaloric diet and placebo</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Placebo will consist in the administration of a number of placebo pills matching that of polyphenols, in a similar way (bid) for the duration of the overfeeding experiment.&#xD;
Overfeeding will consist in a hypercaloric diet providing an excess of 50% KCal over daily requirements, and will last 30 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Hypercaloric diet</intervention_name>
    <description>Hypercaloric diet will be designed to provide 50% excess in calories compared to daily requirements. It will consist in a &quot;snack&quot; type, high fat and high carbohydrates diet.</description>
    <arm_group_label>Hypercaloric diet and placebo</arm_group_label>
    <arm_group_label>Hypercaloric diet and polyphenols</arm_group_label>
    <other_name>Overfeeding</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>polyphenols</intervention_name>
    <description>Administration of polyphenols will consist in the administration of 1 gram (5x200 mg) of the compound bid during the entire overfeeding period.</description>
    <arm_group_label>Hypercaloric diet and polyphenols</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>placebo (for polyphenols)</intervention_name>
    <description>Placebo will consist in the administration of a number of placebo pills matching that of polyphenols, in a similar way (bid) for the duration of the overfeeding experiment.</description>
    <arm_group_label>Hypercaloric diet and placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  normal healthy male and female volunteer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diabetes mellitus&#xD;
&#xD;
          -  High blood pressure&#xD;
&#xD;
          -  Liver disease&#xD;
&#xD;
          -  Kidney disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Francois P Pralong, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hospitalier Universitaire Vaudois</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>François P Pralong, MD</last_name>
    <phone>+41 21 314 0596</phone>
    <email>Francois.Pralong@chuv.ch</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHUVaudois</name>
      <address>
        <city>Lausanne</city>
        <state>Vaud</state>
        <zip>1011</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Weilin Kong, MD</last_name>
    </contact>
    <investigator>
      <last_name>Francois P Pralong, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>July 21, 2014</study_first_submitted>
  <study_first_submitted_qc>August 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 26, 2014</study_first_posted>
  <last_update_submitted>March 5, 2016</last_update_submitted>
  <last_update_submitted_qc>March 5, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 8, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centre Hospitalier Universitaire Vaudois</investigator_affiliation>
    <investigator_full_name>Francois Pralong</investigator_full_name>
    <investigator_title>Full Professor and Head, Cervice of Endocrinology, Diabetology and Metabolism</investigator_title>
  </responsible_party>
  <keyword>insulin resistance</keyword>
  <keyword>type 2 diabetes</keyword>
  <keyword>obesity</keyword>
  <keyword>polyphenols</keyword>
  <keyword>adipose tissue</keyword>
  <keyword>overfeeding</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</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/NCT02225457
org study id: 391/13
secondary id: SNF 320030_141065
nct id: NCT02225457
lead sponsor: 
collaborator: 
has dmc: No
Obesity results from complex interactions between genetic and environmental factors, and are
      strongly associated with metabolic complications such as type 2 diabetes mellitus. Obesity is
      defined as an excessive fat accumulation that presents a risk to health, a risk that is
      highly dependent upon the type of adipose tissue accumulation, whether visceral or
      sub-cutaneous, but also upon the characteristics of the fat tissue, especially inflammatory
      cells accumulation. Because of the well known sexual difference in fat accretion, this
      obesity-associated risk may also be very different for men and for women. In addition, recent
      data indicate that various factors such as the intestinal microbiota, but also the dietary
      intake of protective nutrients might be important determinants of the metabolic complications
      of obesity.

      Here we propose to: 1) study the metabolic adaptations and the mechanisms of adipose tissue
      accumulation during a period of controlled caloric over-nutrition, both in men and in women;
      2) evaluate the potential protective effects of a supplementation with polyphenols on insulin
      resistance and other metabolic adaptations.
To achieve these goals, healthy male and female volunteers will be enrolled into a one month
      longitudinal, prospective study on the influence of hypercaloric overfeeding (+50% of daily
      caloric needs) on different tissues (adipose tissue, muscle and blood).

      They will be separated into two different groups: hypercaloric nutrition and placebo, and
      hypercaloric nutrition and polyphenols (2g/day), where polyphenols administration will be
      randomized and administered in a double blind fashion. Whole body and hepatic insulin
      sensitivity, total energy expenditure, glucose hepatic production, protein and gene
      expression in muscle, adipose tissue and blood as well as intestinal microbiota will be
      assessed at base line, and after one month of overfeeding.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change from baseline in insulin sensitivity
time frame: baseline, day 31 of overfeeding
description: Whole body insulin sensitivity will be measured during hyperinsulinemic, euglycemic clamps.
measure: Change from baseline in muscle and adipose tissue gene expression
time frame: Baseline, day 28 of overfeeding
description: Transcriptomic experiments will be performed on muscle and adipose tissue samples
arm group label: Hypercaloric diet and polyphenols
arm group type: Experimental
description: polyphenols will consist in the administration of 1 gram (5x200 mg) of the compound bid during the entire overfeeding period.
Hypercaloric diet will consist in a hypercaloric diet providing an excess of 50% KCal over daily requirements, and will last 30 days.
arm group label: Hypercaloric diet and placebo
arm group type: Active Comparator
description: Placebo will consist in the administration of a number of placebo pills matching that of polyphenols, in a similar way (bid) for the duration of the overfeeding experiment.
Overfeeding will consist in a hypercaloric diet providing an excess of 50% KCal over daily requirements, and will last 30 days.
intervention type: Other
intervention name: Hypercaloric diet
description: Hypercaloric diet will be designed to provide 50% excess in calories compared to daily requirements. It will consist in a "snack" type, high fat and high carbohydrates diet.
arm group label: Hypercaloric diet and placebo
arm group label: Hypercaloric diet and polyphenols
other name: Overfeeding
intervention type: Dietary Supplement
intervention name: polyphenols
description: Administration of polyphenols will consist in the administration of 1 gram (5x200 mg) of the compound bid during the entire overfeeding period.
arm group label: Hypercaloric diet and polyphenols
intervention type: Dietary Supplement
intervention name: placebo (for polyphenols)
description: Placebo will consist in the administration of a number of placebo pills matching that of polyphenols, in a similar way (bid) for the duration of the overfeeding experiment.
arm group label: Hypercaloric diet and placebo
criteria: 
gender: All
minimum age: 20 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Francois P Pralong, MD
role: Principal Investigator
affiliation: Centre Hospitalier Universitaire Vaudois
last name: François P Pralong, MD
phone: +41 21 314 0596
email: Francois.Pralong@chuv.ch
facility: 
status: Recruiting
contact: 
investigator: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: Centre Hospitalier Universitaire Vaudois
investigator full name: Francois Pralong
investigator title: Full Professor and Head, Cervice of Endocrinology, Diabetology and Metabolism
mesh term: Obesity