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

About this trial
This is an interventional prevention trial for Overweight and Obesity
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
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
NCT ID
NCT03258203
First Posted
August 11, 2017
Last Updated
August 26, 2019
Sponsor
Tulane University
Collaborators
Brigham and Women's Hospital
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
Learn more about this trial
Gene-Environment Interaction and Precision Nutrition on Adiposity, Glycemic, Lipids Changes, and Bone Health
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