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Gene-Environment Interaction and Precision Nutrition on Adiposity, Glycemic, Lipids Changes, and Bone Health

Primary Purpose

Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Preventing Overweight Using Novel Dietary Strategies
Sponsored by
Tulane University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight and Obesity

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Only accepting participants in the Boston, Massachusetts or Baton Rouge, Louisiana area
  • Between the ages of 30 - 70
  • Willing to modify eating pattern according to instructions
  • Overweight or obese and in good health with a BMI of 25-40
  • Committed to a long-term weight loss and maintenance program
  • Willing to attend multiple weight loss group sessions
  • Willing to increase activity level

Exclusion Criteria:

  • Pregnant, planning to become pregnant, or are breastfeeding
  • Unwilling to participate in the schedule of group sessions and individual visits
  • Unstable or recent onset of heart disease or any other serious illness
  • Cannot change diet due to medical or other reasons
  • Planning to leave the area prior to the anticipated end of participation
  • Current participation in another clinical trial with an intervention that affects weight change
  • Have diabetes that is treated with insulin or hypoglycemic oral medicines
  • Diagnosis of psychiatric or emotional problems within 6 months of study
  • Currently have an eating disorder
  • Have hypothyroidism
  • Have an unstable weight

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    diet 1

    diet 2

    diet 3

    diet 4

    Arm Description

    diet with moderate in fat (40% energy) and protein(15%)

    diet with moderate in fat (40% energy) and protein(25%)

    diet with low in fat (20% energy) and protein(15%)

    diet with low in fat (20% energy) and protein(25%)

    Outcomes

    Primary Outcome Measures

    Test the interactions between the genes and diet interventions varying in macronutrient intake on body weight changes(weight in kilograms) .

    Secondary Outcome Measures

    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).
    Test the interactions between the genes and diet interventions varying in macronutrient intake on waist circumference changes (cm).
    Test the interactions between the genes and diet interventions varying in macronutrient intake on visceral fat changes (%).
    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).
    Test the interactions between the genes and diet interventions varying in macronutrient intake on bone health (Bone mineral density at different skeletal sites).
    Bone mineral density was measured by dual-energy X-ray (DEXA)

    Full Information

    First Posted
    August 11, 2017
    Last Updated
    August 26, 2019
    Sponsor
    Tulane University
    Collaborators
    Brigham and Women's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03258203
    Brief Title
    Gene-Environment Interaction and Precision Nutrition on Adiposity, Glycemic, Lipids Changes, and Bone Health
    Official Title
    Obesity Genes, Energy Regulation in Response to Weight-Loss
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2003 (Actual)
    Primary Completion Date
    December 2010 (Actual)
    Study Completion Date
    December 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Tulane University
    Collaborators
    Brigham and Women's Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Overweight and Obesity

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    811 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    diet 1
    Arm Type
    Experimental
    Arm Description
    diet with moderate in fat (40% energy) and protein(15%)
    Arm Title
    diet 2
    Arm Type
    Experimental
    Arm Description
    diet with moderate in fat (40% energy) and protein(25%)
    Arm Title
    diet 3
    Arm Type
    Experimental
    Arm Description
    diet with low in fat (20% energy) and protein(15%)
    Arm Title
    diet 4
    Arm Type
    Experimental
    Arm Description
    diet with low in fat (20% energy) and protein(25%)
    Intervention Type
    Other
    Intervention Name(s)
    Preventing Overweight Using Novel Dietary Strategies
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    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
    Secondary Outcome Measure Information:
    Title
    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
    Title
    Test the interactions between the genes and diet interventions varying in macronutrient intake on waist circumference changes (cm).
    Time Frame
    measured at Year 2
    Title
    Test the interactions between the genes and diet interventions varying in macronutrient intake on visceral fat changes (%).
    Time Frame
    measured at Year 2
    Title
    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
    Title
    Test the interactions between the genes and diet interventions varying in macronutrient intake on bone health (Bone mineral density at different skeletal sites).
    Description
    Bone mineral density was measured by dual-energy X-ray (DEXA)
    Time Frame
    measured at Year 2
    Other Pre-specified Outcome Measures:
    Title
    Ectopic fat
    Description
    Computed tomography (CT) measured hepatic fat, abdominal fat distribution (includes visercal adipose tissue, subcutaneous adipose tissue, and total adipose tissue)
    Time Frame
    2 year (measured at baseline, 6 months, and 2 years)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Only accepting participants in the Boston, Massachusetts or Baton Rouge, Louisiana area Between the ages of 30 - 70 Willing to modify eating pattern according to instructions Overweight or obese and in good health with a BMI of 25-40 Committed to a long-term weight loss and maintenance program Willing to attend multiple weight loss group sessions Willing to increase activity level Exclusion Criteria: Pregnant, planning to become pregnant, or are breastfeeding Unwilling to participate in the schedule of group sessions and individual visits Unstable or recent onset of heart disease or any other serious illness Cannot change diet due to medical or other reasons Planning to leave the area prior to the anticipated end of participation Current participation in another clinical trial with an intervention that affects weight change Have diabetes that is treated with insulin or hypoglycemic oral medicines Diagnosis of psychiatric or emotional problems within 6 months of study Currently have an eating disorder Have hypothyroidism Have an unstable weight

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    30475961
    Citation
    Zhou T, Sun D, Heianza Y, Li X, Champagne CM, LeBoff MS, Shang X, Pei X, Bray GA, Sacks FM, Qi L. Genetically determined vitamin D levels and change in bone density during a weight-loss diet intervention: the Preventing Overweight Using Novel Dietary Strategies (POUNDS Lost) Trial. Am J Clin Nutr. 2018 Nov 1;108(5):1129-1134. doi: 10.1093/ajcn/nqy197.
    Results Reference
    derived
    PubMed Identifier
    28931532
    Citation
    Han L, Ma W, Sun D, Heianza Y, Wang T, Zheng Y, Huang T, Duan D, Bray JGA, Champagne CM, Sacks FM, Qi L. Genetic variation of habitual coffee consumption and glycemic changes in response to weight-loss diet intervention: the Preventing Overweight Using Novel Dietary Strategies (POUNDS LOST) trial. Am J Clin Nutr. 2017 Nov;106(5):1321-1326. doi: 10.3945/ajcn.117.156232. Epub 2017 Sep 20.
    Results Reference
    derived

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    Gene-Environment Interaction and Precision Nutrition on Adiposity, Glycemic, Lipids Changes, and Bone Health

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