<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/NCT01684917</url>
  </required_header>
  <id_info>
    <org_study_id>12/L0/0139</org_study_id>
    <nct_id>NCT01684917</nct_id>
  </id_info>
  <brief_title>Application of New Technologies and Tools to Nutrition Research</brief_title>
  <acronym>NutriTech</acronym>
  <official_title>Application of New Technologies and Tools to Nutrition Research</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Imperial College London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Imperial College London</source>
  <oversight_info>
    <has_dmc>Yes</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 overall objective of the research is to develop new methods for studying the link between&#xD;
      diet, health and disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The enquiry consists of two part. A metabolomic biomarker discovery study followed by a&#xD;
      randomised controlled trial of moderate dietary induced weight loss.&#xD;
&#xD;
      A cohort of moderately overweight men and women will undergo a metabolomic study follow by&#xD;
      randomised controlled trial of a healthy diet with a 20% energy restriction for a 12 week&#xD;
      period. This intervention will improve the volunteer's body composition and reduce their risk&#xD;
      of developing diabetes.&#xD;
&#xD;
      Extensive tests will be conducted before and after the dietary intervention using emerging&#xD;
      technologies with current state-of-the-art methods. These tests will monitor the numerous&#xD;
      physiological adaptations that have occurred on a gene, cell, organ and organismic level.&#xD;
&#xD;
      The study will, therefore, aim for a scientific breakthrough by developing a series of novel&#xD;
      biological &quot;markers&quot; that can accurately determine an individual's health status.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2012</start_date>
  <completion_date type="Actual">January 2016</completion_date>
  <primary_completion_date type="Actual">June 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>Factorial Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Insulin Sensitivity</measure>
    <time_frame>Baseline, 12 weeks</time_frame>
    <description>Glucose Infusion rate assessed by the euglycemic hyperinsulinemic clamp. Insulin Sensitivity assessment was only performed in the &quot;Exercise&quot; and &quot;Exercise, Control&quot; groups. No data were collected for this Outcome from the remaining groups.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Metabolomic Biomarker Discovery - Changes in Blood Plasma Cholesterol</measure>
    <time_frame>Baseline, 12 weeks</time_frame>
    <description>Changes in blood plasma cholesterol in mg/dL- baseline to 12 weeks, after treatment. Statistical Analysis was performed only for the &quot;Diet&quot; Arm/Group.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body Composition</measure>
    <time_frame>Baseline, 12 weeks</time_frame>
    <description>Body Composition assessed by BMI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Adipocyte Morphology</measure>
    <time_frame>12 weeks</time_frame>
    <description>Percentage Change in total adipose tissue assessed by MRI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Genome Integrity (DNA Methylation and Telomere Length)</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Weight</measure>
    <time_frame>Baseline, 12 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Obesity</condition>
  <condition>Diabetes</condition>
  <arm_group>
    <arm_group_label>Life style advice</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>reduce energy intake by 20% less than estimated energy expenditure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>UK background diet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Diet where energy intake will be matched with estimated energy expenditure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Metabolomic inquiry</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>This inquiry took place prior to the randomized controlled trial and include 50 volunteers who will then be asked to volunteers of the weight loss study. Were randomly assigned to one of five different diets; red meat, fish, poultry, processed meat or a supplement and vegetarian option.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Metabolomic and Energy Intake Restriction</intervention_name>
    <description>Metabolomic inquiry followed by a 12 week energy intake restriction. This study is part of a very large European study called EPIC. Only the results by Lee et al. 2016 have been presented here. The results of the study published by Cheung 2017 are from a different study. therefore the entries for the results are correct. For this particular study, participants were not randomly assigned to one of five different diets; red meat, fish, poultry, processed meat or a supplement and vegetarian option. In summary, both studies (lee and cheung) are considered as separate trials and results of the first phase where participants were assigned to one of five different diets, are reported separately. Unfortunately no different NCT number is available.</description>
    <arm_group_label>Life style advice</arm_group_label>
    <arm_group_label>Metabolomic inquiry</arm_group_label>
    <arm_group_label>UK background diet</arm_group_label>
    <other_name>Energy restriction diet</other_name>
    <other_name>Metabolomic</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy overweight volunteers (body mass index (BMI) of 25-30 kg/m2)&#xD;
&#xD;
          -  Age between 50-65 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Weight change of ≥ 3kg in the preceding 3 months&#xD;
&#xD;
          -  Current smokers&#xD;
&#xD;
          -  Substance abuse&#xD;
&#xD;
          -  Excess alcohol intake&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  Cardiovascular disease&#xD;
&#xD;
          -  Cancer&#xD;
&#xD;
          -  Gastrointestinal disease e.g. inflammatory bowel disease or irritable bowel syndrome&#xD;
&#xD;
          -  Kidney disease&#xD;
&#xD;
          -  Liver disease&#xD;
&#xD;
          -  Pancreatitis&#xD;
&#xD;
          -  Have any metallic or magnetic implants such as pacemakers&#xD;
&#xD;
          -  Use of medications likely to interfere with energy metabolism, appetite regulation and&#xD;
             hormonal balance, including: anti inflammatory drugs or steroids, antibiotics,&#xD;
             androgens, phenytoin, erythromycin or thyroid hormones.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gary S Frost</last_name>
    <role>Principal Investigator</role>
    <affiliation>Imperial College London</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Imperial College London</name>
      <address>
        <city>London</city>
        <zip>W12 0NN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <results_reference>
    <citation>Lee S, Norheim F, Langleite TM, Noreng HJ, Storas TH, Afman LA, Frost G, Bell JD, Thomas EL, Kolnes KJ, Tangen DS, Stadheim HK, Gilfillan GD, Gulseth HL, Birkeland KI, Jensen J, Drevon CA, Holen T; NutriTech Consortium. Effect of energy restriction and physical exercise intervention on phenotypic flexibility as examined by transcriptomics analyses of mRNA from adipose tissue and whole body magnetic resonance imaging. Physiol Rep. 2016 Nov;4(21):e13019. doi: 10.14814/phy2.13019.</citation>
    <PMID>27821717</PMID>
  </results_reference>
  <results_reference>
    <citation>Cheung W, Keski-Rahkonen P, Assi N, Ferrari P, Freisling H, Rinaldi S, Slimani N, Zamora-Ros R, Rundle M, Frost G, Gibbons H, Carr E, Brennan L, Cross AJ, Pala V, Panico S, Sacerdote C, Palli D, Tumino R, Kuhn T, Kaaks R, Boeing H, Floegel A, Mancini F, Boutron-Ruault MC, Baglietto L, Trichopoulou A, Naska A, Orfanos P, Scalbert A. A metabolomic study of biomarkers of meat and fish intake. Am J Clin Nutr. 2017 Mar;105(3):600-608. doi: 10.3945/ajcn.116.146639. Epub 2017 Jan 25.</citation>
    <PMID>28122782</PMID>
  </results_reference>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>September 11, 2012</study_first_submitted>
  <study_first_submitted_qc>September 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 13, 2012</study_first_posted>
  <results_first_submitted>October 24, 2019</results_first_submitted>
  <results_first_submitted_qc>January 13, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">January 27, 2020</results_first_posted>
  <last_update_submitted>January 13, 2020</last_update_submitted>
  <last_update_submitted_qc>January 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Obesity</keyword>
  <keyword>Metabolites</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Exercise</title>
          <description>An overweight/dysglycemic group&#xD;
4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks</description>
        </group>
        <group group_id="P2">
          <title>Diet</title>
          <description>overweight/ obese subjects with normal glucose metabolism with energy restriction, 20% reduced intake of energy from food for 12 weeks.&#xD;
Energy intake was matched with estimated energy expenditure</description>
        </group>
        <group group_id="P3">
          <title>Exercise, Control</title>
          <description>An overweight with no dysglycemia 4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks</description>
        </group>
        <group group_id="P4">
          <title>Diet, Control</title>
          <description>overweight/ obese subjects with normal glucose metabolism for 12 weeks&#xD;
Energy intake was matched with estimated energy expenditure</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="13"/>
                <participants group_id="P4" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="13"/>
                <participants group_id="P4" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Exercise</title>
          <description>An overweight/dysglycemic group&#xD;
4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks</description>
        </group>
        <group group_id="B2">
          <title>Diet</title>
          <description>overweight/ obese subjects with normal glucose metabolism with energy restriction, 20% reduced intake of energy from food for 12 weeks</description>
        </group>
        <group group_id="B3">
          <title>Exercise, Control</title>
          <description>An overweight with no dysglycemia 4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks</description>
        </group>
        <group group_id="B4">
          <title>Diet, Control</title>
          <description>overweight/ obese subjects with normal glucose metabolism for 12 weeks</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="11"/>
            <count group_id="B2" value="7"/>
            <count group_id="B3" value="13"/>
            <count group_id="B4" value="5"/>
            <count group_id="B5" value="36"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                    <count group_id="B2" value="7"/>
                    <count group_id="B3" value="13"/>
                    <count group_id="B4" value="5"/>
                    <count group_id="B5" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53" spread="1.7"/>
                    <measurement group_id="B2" value="59" spread="1.3"/>
                    <measurement group_id="B3" value="50" spread="2.1"/>
                    <measurement group_id="B4" value="57" spread="2.7"/>
                    <measurement group_id="B5" value="55" spread="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                    <count group_id="B2" value="7"/>
                    <count group_id="B3" value="13"/>
                    <count group_id="B4" value="5"/>
                    <count group_id="B5" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="0"/>
                    <count group_id="B5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United Kingdom</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                    <count group_id="B2" value="7"/>
                    <count group_id="B3" value="13"/>
                    <count group_id="B4" value="5"/>
                    <count group_id="B5" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <description>As shown in table 1 of the publication by Lee at al 2016, the unit measure used was kg/m2.</description>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                    <count group_id="B2" value="7"/>
                    <count group_id="B3" value="13"/>
                    <count group_id="B4" value="5"/>
                    <count group_id="B5" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28.9" spread="2.5"/>
                    <measurement group_id="B2" value="30.8" spread="3.1"/>
                    <measurement group_id="B3" value="23.5" spread="2"/>
                    <measurement group_id="B4" value="29.1" spread="2"/>
                    <measurement group_id="B5" value="28" spread="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Fasting glucose</title>
          <description>As shown in table 1 of the publication by Lee at al 2016, the unit measure used was mmol/L.</description>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                    <count group_id="B2" value="7"/>
                    <count group_id="B3" value="13"/>
                    <count group_id="B4" value="5"/>
                    <count group_id="B5" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.8" spread="0.4"/>
                    <measurement group_id="B2" value="5.0" spread="0.6"/>
                    <measurement group_id="B3" value="5.4" spread="0.1"/>
                    <measurement group_id="B4" value="4.6" spread="0.3"/>
                    <measurement group_id="B5" value="5.2" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Total cholesterol</title>
          <description>As shown in table 1 of the publication (Lee et al 2016), the unit measure for cholesterol is mg/dL.</description>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                    <count group_id="B2" value="7"/>
                    <count group_id="B3" value="13"/>
                    <count group_id="B4" value="5"/>
                    <count group_id="B5" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.6" spread="0.5"/>
                    <measurement group_id="B2" value="5.6" spread="1.2"/>
                    <measurement group_id="B3" value="5.1" spread="0.2"/>
                    <measurement group_id="B4" value="4.9" spread="0.3"/>
                    <measurement group_id="B5" value="5.2" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Insulin Sensitivity</title>
        <description>Glucose Infusion rate assessed by the euglycemic hyperinsulinemic clamp. Insulin Sensitivity assessment was only performed in the &quot;Exercise&quot; and &quot;Exercise, Control&quot; groups. No data were collected for this Outcome from the remaining groups.</description>
        <time_frame>Baseline, 12 weeks</time_frame>
        <population>No data available for diet and diet-control group</population>
        <group_list>
          <group group_id="O1">
            <title>Exercise</title>
            <description>An overweight/dysglycemic group&#xD;
4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>Diet</title>
            <description>overweight/ obese subjects with normal glucose metabolism with energy restriction, 20% reduced intake of energy from food for 12 weeks</description>
          </group>
          <group group_id="O3">
            <title>Exercise, Control</title>
            <description>An overweight with no dysglycemia 4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks</description>
          </group>
          <group group_id="O4">
            <title>Diet, Control</title>
            <description>overweight/ obese subjects with normal glucose metabolism for 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Insulin Sensitivity</title>
          <description>Glucose Infusion rate assessed by the euglycemic hyperinsulinemic clamp. Insulin Sensitivity assessment was only performed in the &quot;Exercise&quot; and &quot;Exercise, Control&quot; groups. No data were collected for this Outcome from the remaining groups.</description>
          <population>No data available for diet and diet-control group</population>
          <units>mg/kg/min</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.2" spread="1.8"/>
                    <measurement group_id="O3" value="7.6" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.4" spread="1.8"/>
                    <measurement group_id="O3" value="10.4" spread="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Baseline vs 12 weeks</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <p_value_desc>calculated. The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance</p_value_desc>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Baseline vs 12 weeks</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <p_value_desc>calculated. The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance.</p_value_desc>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Metabolomic Biomarker Discovery - Changes in Blood Plasma Cholesterol</title>
        <description>Changes in blood plasma cholesterol in mg/dL- baseline to 12 weeks, after treatment. Statistical Analysis was performed only for the &quot;Diet&quot; Arm/Group.</description>
        <time_frame>Baseline, 12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Exercise</title>
            <description>An overweight/dysglycemic group&#xD;
4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>Diet</title>
            <description>overweight/ obese subjects with normal glucose metabolism with energy restriction, 20% reduced intake of energy from food for 12 weeks</description>
          </group>
          <group group_id="O3">
            <title>Exercise, Control</title>
            <description>An overweight with no dysglycemia 4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks</description>
          </group>
          <group group_id="O4">
            <title>Diet, Control</title>
            <description>overweight/ obese subjects with normal glucose metabolism for 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Metabolomic Biomarker Discovery - Changes in Blood Plasma Cholesterol</title>
          <description>Changes in blood plasma cholesterol in mg/dL- baseline to 12 weeks, after treatment. Statistical Analysis was performed only for the &quot;Diet&quot; Arm/Group.</description>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.6" spread="0.5"/>
                    <measurement group_id="O2" value="5.6" spread="1.2"/>
                    <measurement group_id="O3" value="5.1" spread="0.2"/>
                    <measurement group_id="O4" value="4.9" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.8" spread="0.7"/>
                    <measurement group_id="O2" value="4.9" spread="1.3"/>
                    <measurement group_id="O3" value="4.9" spread="0.1"/>
                    <measurement group_id="O4" value="5.1" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Baseline vs 12 weeks. Statistical Analysis was performed only for the &quot;Diet&quot; Arm/Group.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Statistical Analysis was performed only for the &quot;Diet&quot; Arm/Group</non_inferiority_desc>
            <p_value>&lt;0.05</p_value>
            <p_value_desc>calculated. The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance</p_value_desc>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Body Composition</title>
        <description>Body Composition assessed by BMI</description>
        <time_frame>Baseline, 12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Exercise</title>
            <description>An overweight/dysglycemic group&#xD;
4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>Diet</title>
            <description>overweight/ obese subjects with normal glucose metabolism with energy restriction, 20% reduced intake of energy from food for 12 weeks</description>
          </group>
          <group group_id="O3">
            <title>Exercise, Control</title>
            <description>An overweight with no dysglycemia 4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks</description>
          </group>
          <group group_id="O4">
            <title>Diet, Control</title>
            <description>overweight/ obese subjects with normal glucose metabolism for 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Body Composition</title>
          <description>Body Composition assessed by BMI</description>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.9" spread="2.5"/>
                    <measurement group_id="O2" value="30.8" spread="3.1"/>
                    <measurement group_id="O3" value="23.5" spread="2"/>
                    <measurement group_id="O4" value="29.1" spread="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.6" spread="2.4"/>
                    <measurement group_id="O2" value="29.2" spread="3"/>
                    <measurement group_id="O3" value="23.5" spread="1.8"/>
                    <measurement group_id="O4" value="29.1" spread="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Baseline vs 12 weeks. Statistical Analysis was performed only for the &quot;Diet&quot; Arm/Group.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Statistical Analysis was performed only for the &quot;Diet&quot; Arm/Group</non_inferiority_desc>
            <p_value>&lt;0.05</p_value>
            <p_value_desc>calculated. The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance.</p_value_desc>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Adipocyte Morphology</title>
        <description>Percentage Change in total adipose tissue assessed by MRI</description>
        <time_frame>12 weeks</time_frame>
        <population>1 missing data in diet group</population>
        <group_list>
          <group group_id="O1">
            <title>Exercise</title>
            <description>An overweight/dysglycemic group&#xD;
4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>Diet</title>
            <description>overweight/ obese subjects with normal glucose metabolism with energy restriction, 20% reduced intake of energy from food for 12 weeks</description>
          </group>
          <group group_id="O3">
            <title>Exercise, Control</title>
            <description>An overweight with no dysglycemia 4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks</description>
          </group>
          <group group_id="O4">
            <title>Diet, Control</title>
            <description>overweight/ obese subjects with normal glucose metabolism for 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Adipocyte Morphology</title>
          <description>Percentage Change in total adipose tissue assessed by MRI</description>
          <population>1 missing data in diet group</population>
          <units>percentage change</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.9" spread="5.1"/>
                    <measurement group_id="O2" value="-8.9" spread="3.3"/>
                    <measurement group_id="O3" value="-8.5" spread="2.7"/>
                    <measurement group_id="O4" value="3.7" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Baseline vs 12 weeks</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <p_value_desc>The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance</p_value_desc>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Baseline vs 12 weeks</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <p_value_desc>The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance</p_value_desc>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Baseline vs 12 weeks</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <p_value_desc>The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance</p_value_desc>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Genome Integrity (DNA Methylation and Telomere Length)</title>
        <time_frame>12 weeks</time_frame>
        <population>Data not collected</population>
        <group_list>
          <group group_id="O1">
            <title>Exercise</title>
            <description>An overweight/dysglycemic group&#xD;
4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>Diet</title>
            <description>overweight/ obese subjects with normal glucose metabolism with energy restriction, 20% reduced intake of energy from food for 12 weeks</description>
          </group>
          <group group_id="O3">
            <title>Exercise, Control</title>
            <description>An overweight with no dysglycemia 4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks</description>
          </group>
          <group group_id="O4">
            <title>Diet, Control</title>
            <description>overweight/ obese subjects with normal glucose metabolism for 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Genome Integrity (DNA Methylation and Telomere Length)</title>
          <population>Data not collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Body Weight</title>
        <time_frame>Baseline, 12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Exercise</title>
            <description>An overweight/dysglycemic group&#xD;
4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>Diet</title>
            <description>overweight/ obese subjects with normal glucose metabolism with energy restriction, 20% reduced intake of energy from food for 12 weeks</description>
          </group>
          <group group_id="O3">
            <title>Exercise, Control</title>
            <description>An overweight with no dysglycemia 4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks</description>
          </group>
          <group group_id="O4">
            <title>Diet, Control</title>
            <description>overweight/ obese subjects with normal glucose metabolism for 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Body Weight</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.9" spread="9"/>
                    <measurement group_id="O2" value="91.9" spread="17.8"/>
                    <measurement group_id="O3" value="78.5" spread="2.3"/>
                    <measurement group_id="O4" value="84.7" spread="4.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.6" spread="9.1"/>
                    <measurement group_id="O2" value="87.3" spread="17.4"/>
                    <measurement group_id="O3" value="78.3" spread="2.3"/>
                    <measurement group_id="O4" value="84.5" spread="4.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Baseline vs 12 weeks. Statistical Analysis was performed only for the &quot;Diet&quot; Arm/Group.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Statistical Analysis was performed only for the &quot;Diet&quot; Arm/Group</non_inferiority_desc>
            <p_value>&lt;0.05</p_value>
            <p_value_desc>calculated. The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance</p_value_desc>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Exercise</title>
          <description>An overweight/dysglycemic group&#xD;
4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks</description>
        </group>
        <group group_id="E2">
          <title>Diet</title>
          <description>overweight/ obese subjects with normal glucose metabolism with energy restriction, 20% reduced intake of energy from food for 12 weeks</description>
        </group>
        <group group_id="E3">
          <title>Exercise, Control</title>
          <description>An overweight with no dysglycemia 4 h of intense exercise each week, including two whole-body strength-training sessions and two spinning bike interval sessions for 12 weeks</description>
        </group>
        <group group_id="E4">
          <title>Diet, Control</title>
          <description>overweight/ obese subjects with normal glucose metabolism for 12 weeks</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Professor Gary Frost</name_or_title>
      <organization>Imperial College London</organization>
      <phone>+44 (0)20 7594 0959</phone>
      <email>g.frost@imperial.ac.uk</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01684917
org study id: 12/L0/0139
nct id: NCT01684917
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The overall objective of the research is to develop new methods for studying the link between
      diet, health and disease.
The enquiry consists of two part. A metabolomic biomarker discovery study followed by a
      randomised controlled trial of moderate dietary induced weight loss.

      A cohort of moderately overweight men and women will undergo a metabolomic study follow by
      randomised controlled trial of a healthy diet with a 20% energy restriction for a 12 week
      period. This intervention will improve the volunteer's body composition and reduce their risk
      of developing diabetes.

      Extensive tests will be conducted before and after the dietary intervention using emerging
      technologies with current state-of-the-art methods. These tests will monitor the numerous
      physiological adaptations that have occurred on a gene, cell, organ and organismic level.

      The study will, therefore, aim for a scientific breakthrough by developing a series of novel
      biological "markers" that can accurately determine an individual's health status.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Diagnostic
masking: Double (Participant, Outcomes Assessor)
measure: Insulin Sensitivity
time frame: Baseline, 12 weeks
description: Glucose Infusion rate assessed by the euglycemic hyperinsulinemic clamp. Insulin Sensitivity assessment was only performed in the "Exercise" and "Exercise, Control" groups. No data were collected for this Outcome from the remaining groups.
measure: Metabolomic Biomarker Discovery - Changes in Blood Plasma Cholesterol
time frame: Baseline, 12 weeks
description: Changes in blood plasma cholesterol in mg/dL- baseline to 12 weeks, after treatment. Statistical Analysis was performed only for the "Diet" Arm/Group.
measure: Body Composition
time frame: Baseline, 12 weeks
description: Body Composition assessed by BMI
measure: Changes in Adipocyte Morphology
time frame: 12 weeks
description: Percentage Change in total adipose tissue assessed by MRI
measure: Genome Integrity (DNA Methylation and Telomere Length)
time frame: 12 weeks
measure: Body Weight
time frame: Baseline, 12 weeks
arm group label: Life style advice
arm group type: Experimental
description: reduce energy intake by 20% less than estimated energy expenditure.
arm group label: UK background diet
arm group type: Active Comparator
description: Diet where energy intake will be matched with estimated energy expenditure.
arm group label: Metabolomic inquiry
arm group type: Other
description: This inquiry took place prior to the randomized controlled trial and include 50 volunteers who will then be asked to volunteers of the weight loss study. Were randomly assigned to one of five different diets; red meat, fish, poultry, processed meat or a supplement and vegetarian option.
intervention type: Behavioral
intervention name: Metabolomic and Energy Intake Restriction
description: Metabolomic inquiry followed by a 12 week energy intake restriction. This study is part of a very large European study called EPIC. Only the results by Lee et al. 2016 have been presented here. The results of the study published by Cheung 2017 are from a different study. therefore the entries for the results are correct. For this particular study, participants were not randomly assigned to one of five different diets; red meat, fish, poultry, processed meat or a supplement and vegetarian option. In summary, both studies (lee and cheung) are considered as separate trials and results of the first phase where participants were assigned to one of five different diets, are reported separately. Unfortunately no different NCT number is available.
arm group label: Life style advice
arm group label: Metabolomic inquiry
arm group label: UK background diet
other name: Energy restriction diet
other name: Metabolomic
criteria: 
gender: All
minimum age: 50 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gary S Frost
role: Principal Investigator
affiliation: Imperial College London
facility: 
country: United Kingdom
citation: Lee S, Norheim F, Langleite TM, Noreng HJ, Storas TH, Afman LA, Frost G, Bell JD, Thomas EL, Kolnes KJ, Tangen DS, Stadheim HK, Gilfillan GD, Gulseth HL, Birkeland KI, Jensen J, Drevon CA, Holen T; NutriTech Consortium. Effect of energy restriction and physical exercise intervention on phenotypic flexibility as examined by transcriptomics analyses of mRNA from adipose tissue and whole body magnetic resonance imaging. Physiol Rep. 2016 Nov;4(21):e13019. doi: 10.14814/phy2.13019.
PMID: 27821717
citation: Cheung W, Keski-Rahkonen P, Assi N, Ferrari P, Freisling H, Rinaldi S, Slimani N, Zamora-Ros R, Rundle M, Frost G, Gibbons H, Carr E, Brennan L, Cross AJ, Pala V, Panico S, Sacerdote C, Palli D, Tumino R, Kuhn T, Kaaks R, Boeing H, Floegel A, Mancini F, Boutron-Ruault MC, Baglietto L, Trichopoulou A, Naska A, Orfanos P, Scalbert A. A metabolomic study of biomarkers of meat and fish intake. Am J Clin Nutr. 2017 Mar;105(3):600-608. doi: 10.3945/ajcn.116.146639. Epub 2017 Jan 25.
PMID: 28122782
responsible party type: Sponsor
mesh term: Obesity
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
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