<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/NCT03258203</url>
  </required_header>
  <id_info>
    <org_study_id>R01DK091718</org_study_id>
    <nct_id>NCT03258203</nct_id>
  </id_info>
  <brief_title>Gene-Environment Interaction and Precision Nutrition on Adiposity, Glycemic, Lipids Changes, and Bone Health</brief_title>
  <official_title>Obesity Genes, Energy Regulation in Response to Weight-Loss</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tulane University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Brigham and Women's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Tulane University</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 purpose of this study is to test the interactions between the genes and diet&#xD;
      interventions varying in macronutrient intake on glycemic, waist circumference, body weight,&#xD;
      visceral fat and lipids changes. In the POUNDS LOST, all of the 811 participants DNA was&#xD;
      extracted from the buffy coat fraction of centrifuged blood using the QIAmp blood kit&#xD;
      (Qiagen, Chatsworth, CA). Single nucleotide polymorphisms were genotyped using the OpenArray™&#xD;
      SNP genotyping system (BioTrove, Woburn, MA). The study is only accepting participants in the&#xD;
      Boston, Massachusetts or Baton Rouge, Louisiana area. For further enrollment information in&#xD;
      Boston or Baton Rouge, see Eligibility Criteria or Design Narrative.&#xD;
&#xD;
      Besides, the investigators integrated novel pathway analyses in large cohorts and&#xD;
      comprehensive genetic analyses on long-term weight loss and mechanisms in randomized diet&#xD;
      intervention trials would provide very important evidence to unravel the etiology of obesity,&#xD;
      and have significant public health and clinical implications. Establishing relationship&#xD;
      between genetic variants and diets in determining weight change will help identify&#xD;
      individuals at high risk for obesity especially when adherent to specific diet.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The epidemic of obesity has become a major public health problem. Obesity is a multifactorial&#xD;
      abnormality that has a genetic basis but requires environmental influences to manifest.&#xD;
      Common-form obesity is underpinned by both environmental and genetic factors. Recent&#xD;
      genome-wide association studies have identified several genes convincingly related to obesity&#xD;
      risk. Testing gene-environment interaction is a relatively new field. Evidence from&#xD;
      association studies and intervention trials continues to mount, indicating that genetic&#xD;
      components may modify lifestyle effects on the development of obesity. However, these&#xD;
      findings are at most preliminary. The interplay between genetic and environmental components&#xD;
      may facilitate the choice of more effective and specific measures for obesity prevention&#xD;
      based on personalized genetic make-up.&#xD;
&#xD;
      The investigators aimed to examine whether the genetic variation affected glycemic, waist&#xD;
      circumference, body weight, visceral fat and lipids changes in response to weight-loss&#xD;
      dietary intervention varying in macronutrient intake (target percentages of energy derived&#xD;
      from fat, protein, and carbohydrate in the 4 diets were as follows 20%, 15% and 65%; 20%,&#xD;
      25%, and 55%; 40%, 15%, and 45%; and 40%, 25%, and 35%).&#xD;
&#xD;
      The primary outcome is to test the interactions between the genes and diet interventions&#xD;
      varying in macronutrient intake on body weight changes. The secondary outcome is to test the&#xD;
      interactions between the genes and diet interventions varying in macronutrient intake on&#xD;
      glycemic, waist circumference, visceral fat, and lipids changes. Understanding gene-diet&#xD;
      interactions in relation to weight loss hold great promise for delivering more efficient&#xD;
      prevention and treatment on obesity and related metabolic disorders.&#xD;
&#xD;
      In addition, besides gene-diet interactions, the investigators will also conduct other&#xD;
      precision nutrition analysis. These analyses include interactions between pretreatment&#xD;
      factors with diet intervention adiposity traits, initial changes induced by diet intervention&#xD;
      with various outcomes measured in POUNDS Lost, including body weight, waist circumference,&#xD;
      body composition, ectopic fat, and bone health.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2003</start_date>
  <completion_date type="Actual">December 2010</completion_date>
  <primary_completion_date type="Actual">December 2010</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Test the interactions between the genes and diet interventions varying in macronutrient intake on body weight changes(weight in kilograms) .</measure>
    <time_frame>measured at Year 2</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Test the interactions between the genes and diet interventions varying in macronutrient intake on glycemic changes (mg/dL for fasting glucose,uU/mL for fasting insulin).</measure>
    <time_frame>measured at Year 2</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Test the interactions between the genes and diet interventions varying in macronutrient intake on waist circumference changes (cm).</measure>
    <time_frame>measured at Year 2</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Test the interactions between the genes and diet interventions varying in macronutrient intake on visceral fat changes (%).</measure>
    <time_frame>measured at Year 2</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Test the interactions between the genes and diet interventions varying in macronutrient intake on lipids changes (mg/dL for Total cholesterol, HDL cholesterol, LDL cholesterol and Triglycerides).</measure>
    <time_frame>measured at Year 2</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Test the interactions between the genes and diet interventions varying in macronutrient intake on bone health (Bone mineral density at different skeletal sites).</measure>
    <time_frame>measured at Year 2</time_frame>
    <description>Bone mineral density was measured by dual-energy X-ray (DEXA)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Ectopic fat</measure>
    <time_frame>2 year (measured at baseline, 6 months, and 2 years)</time_frame>
    <description>Computed tomography (CT) measured hepatic fat, abdominal fat distribution (includes visercal adipose tissue, subcutaneous adipose tissue, and total adipose tissue)</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">811</enrollment>
  <condition>Overweight and Obesity</condition>
  <arm_group>
    <arm_group_label>diet 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>diet with moderate in fat (40% energy) and protein(15%)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>diet 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>diet with moderate in fat (40% energy) and protein(25%)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>diet 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>diet with low in fat (20% energy) and protein(15%)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>diet 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>diet with low in fat (20% energy) and protein(25%)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Preventing Overweight Using Novel Dietary Strategies</intervention_name>
    <description>The study tests the effectiveness for weight loss and weight maintenance of four diets differing in macronutrient composition: moderate in fat (40% energy) with two different protein levels (15% and 25%), and low in fat (20% energy), also with 15% and 25% protein levels.</description>
    <arm_group_label>diet 1</arm_group_label>
    <arm_group_label>diet 2</arm_group_label>
    <arm_group_label>diet 3</arm_group_label>
    <arm_group_label>diet 4</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Only accepting participants in the Boston, Massachusetts or Baton Rouge, Louisiana&#xD;
             area&#xD;
&#xD;
          -  Between the ages of 30 - 70&#xD;
&#xD;
          -  Willing to modify eating pattern according to instructions&#xD;
&#xD;
          -  Overweight or obese and in good health with a BMI of 25-40&#xD;
&#xD;
          -  Committed to a long-term weight loss and maintenance program&#xD;
&#xD;
          -  Willing to attend multiple weight loss group sessions&#xD;
&#xD;
          -  Willing to increase activity level&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant, planning to become pregnant, or are breastfeeding&#xD;
&#xD;
          -  Unwilling to participate in the schedule of group sessions and individual visits&#xD;
&#xD;
          -  Unstable or recent onset of heart disease or any other serious illness&#xD;
&#xD;
          -  Cannot change diet due to medical or other reasons&#xD;
&#xD;
          -  Planning to leave the area prior to the anticipated end of participation&#xD;
&#xD;
          -  Current participation in another clinical trial with an intervention that affects&#xD;
             weight change&#xD;
&#xD;
          -  Have diabetes that is treated with insulin or hypoglycemic oral medicines&#xD;
&#xD;
          -  Diagnosis of psychiatric or emotional problems within 6 months of study&#xD;
&#xD;
          -  Currently have an eating disorder&#xD;
&#xD;
          -  Have hypothyroidism&#xD;
&#xD;
          -  Have an unstable weight&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>August 11, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <last_update_submitted>August 26, 2019</last_update_submitted>
  <last_update_submitted_qc>August 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tulane University</investigator_affiliation>
    <investigator_full_name>Lu Qi</investigator_full_name>
    <investigator_title>Director of Tulane University Obesity Research Center</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Overweight</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 25, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/03/NCT03258203/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03258203
org study id: R01DK091718
nct id: NCT03258203
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to test the interactions between the genes and diet
      interventions varying in macronutrient intake on glycemic, waist circumference, body weight,
      visceral fat and lipids changes. In the POUNDS LOST, all of the 811 participants DNA was
      extracted from the buffy coat fraction of centrifuged blood using the QIAmp blood kit
      (Qiagen, Chatsworth, CA). Single nucleotide polymorphisms were genotyped using the OpenArray™
      SNP genotyping system (BioTrove, Woburn, MA). The study is only accepting participants in the
      Boston, Massachusetts or Baton Rouge, Louisiana area. For further enrollment information in
      Boston or Baton Rouge, see Eligibility Criteria or Design Narrative.

      Besides, the investigators integrated novel pathway analyses in large cohorts and
      comprehensive genetic analyses on long-term weight loss and mechanisms in randomized diet
      intervention trials would provide very important evidence to unravel the etiology of obesity,
      and have significant public health and clinical implications. Establishing relationship
      between genetic variants and diets in determining weight change will help identify
      individuals at high risk for obesity especially when adherent to specific diet.
The epidemic of obesity has become a major public health problem. Obesity is a multifactorial
      abnormality that has a genetic basis but requires environmental influences to manifest.
      Common-form obesity is underpinned by both environmental and genetic factors. Recent
      genome-wide association studies have identified several genes convincingly related to obesity
      risk. Testing gene-environment interaction is a relatively new field. Evidence from
      association studies and intervention trials continues to mount, indicating that genetic
      components may modify lifestyle effects on the development of obesity. However, these
      findings are at most preliminary. The interplay between genetic and environmental components
      may facilitate the choice of more effective and specific measures for obesity prevention
      based on personalized genetic make-up.

      The investigators aimed to examine whether the genetic variation affected glycemic, waist
      circumference, body weight, visceral fat and lipids changes in response to weight-loss
      dietary intervention varying in macronutrient intake (target percentages of energy derived
      from fat, protein, and carbohydrate in the 4 diets were as follows 20%, 15% and 65%; 20%,
      25%, and 55%; 40%, 15%, and 45%; and 40%, 25%, and 35%).

      The primary outcome is to test the interactions between the genes and diet interventions
      varying in macronutrient intake on body weight changes. The secondary outcome is to test the
      interactions between the genes and diet interventions varying in macronutrient intake on
      glycemic, waist circumference, visceral fat, and lipids changes. Understanding gene-diet
      interactions in relation to weight loss hold great promise for delivering more efficient
      prevention and treatment on obesity and related metabolic disorders.

      In addition, besides gene-diet interactions, the investigators will also conduct other
      precision nutrition analysis. These analyses include interactions between pretreatment
      factors with diet intervention adiposity traits, initial changes induced by diet intervention
      with various outcomes measured in POUNDS Lost, including body weight, waist circumference,
      body composition, ectopic fat, and bone health.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Test the interactions between the genes and diet interventions varying in macronutrient intake on body weight changes(weight in kilograms) .
time frame: measured at Year 2
measure: Test the interactions between the genes and diet interventions varying in macronutrient intake on glycemic changes (mg/dL for fasting glucose,uU/mL for fasting insulin).
time frame: measured at Year 2
measure: Test the interactions between the genes and diet interventions varying in macronutrient intake on waist circumference changes (cm).
time frame: measured at Year 2
measure: Test the interactions between the genes and diet interventions varying in macronutrient intake on visceral fat changes (%).
time frame: measured at Year 2
measure: Test the interactions between the genes and diet interventions varying in macronutrient intake on lipids changes (mg/dL for Total cholesterol, HDL cholesterol, LDL cholesterol and Triglycerides).
time frame: measured at Year 2
measure: Test the interactions between the genes and diet interventions varying in macronutrient intake on bone health (Bone mineral density at different skeletal sites).
time frame: measured at Year 2
description: Bone mineral density was measured by dual-energy X-ray (DEXA)
measure: Ectopic fat
time frame: 2 year (measured at baseline, 6 months, and 2 years)
description: Computed tomography (CT) measured hepatic fat, abdominal fat distribution (includes visercal adipose tissue, subcutaneous adipose tissue, and total adipose tissue)
arm group label: diet 1
arm group type: Experimental
description: diet with moderate in fat (40% energy) and protein(15%)
arm group label: diet 2
arm group type: Experimental
description: diet with moderate in fat (40% energy) and protein(25%)
arm group label: diet 3
arm group type: Experimental
description: diet with low in fat (20% energy) and protein(15%)
arm group label: diet 4
arm group type: Experimental
description: diet with low in fat (20% energy) and protein(25%)
intervention type: Other
intervention name: Preventing Overweight Using Novel Dietary Strategies
description: The study tests the effectiveness for weight loss and weight maintenance of four diets differing in macronutrient composition: moderate in fat (40% energy) with two different protein levels (15% and 25%), and low in fat (20% energy), also with 15% and 25% protein levels.
arm group label: diet 1
arm group label: diet 2
arm group label: diet 3
arm group label: diet 4
criteria: 
gender: All
minimum age: 30 Years
maximum age: 70 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Tulane University
investigator full name: Lu Qi
investigator title: Director of Tulane University Obesity Research Center
mesh term: Obesity
mesh term: Overweight
sharing ipd: No
provided document: 