"ADAPT" The Adaptation to High Fat Diets Extention

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Behavioral: Low Fat Diet; Behavioral: High Fat Diet

• Registration Number: NCT00493701
• Lead Sponsor: Pennington Biomedical Research Center

Brief Summary

This study is designed to predict weight gain overtime after a high fat diet.

Detailed Description

In the past 3 years we have identified a "thrifty-phenotype" characterized in lean men by an inability to adapt rapidly to a high fat diet and associated with a low maximal VO2 and high fasting insulin. We hypothesize that the individuals with the "thrifty phenotype" are at higher risk for becoming obese, and that exercise may be effective in overcoming this problem.

Several questions remain to be answered regarding the "thrifty" phenotype. First, given the large interindividual differences, how can we identify those at the highest risk? What are the distinguishing biochemical, endocrine and environmental characteristics of individuals that store fat when exposed to high fat diets? This is important because if these individuals can be easily identified, then dietary interventions can be targeted to this "at-risk" population.

Second, what is different about the individual with the "thrifty phenotype"? Are there cellular pathways that are dysregulated in the skeletal muscle of these individuals when compared to controls? Is the defect intrinsic, i.e. a diminished ability to conserve glucose and oxidize fat in skeletal muscle or alternately, is the phenotype due to environmental, and dietary factors such as inactivity and energy excess?

To answer these questions, we have planned a three-year project that aims to:

* Characterize the biochemical, endocrine, anthropometric and environmental characteristics of individuals with the "thrifty" phenotype.

* Identify the signaling pathways in skeletal muscle that are dysregulated in individuals with the "thrifty" phenotype through mRNA expression profiling in skeletal tissue.

* Determine the role of environmental factors such as inactivity and caloric intake vs. intrinsic (genetic) factors in the "thrifty" phenotype.

Study Timeline

• Study First Submitted: 2007-06-26
• Study First Submitted QC: 2007-06-26
• Study First Posted: 2007-06-28
• Study Start: 2016-07
• Primary Completion: 2020-03-04
• Study Completion: 2020-03-04
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-13
• Last Update Posted: 2022-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Both genders and all races will be invited to participate
• Women will be asked to participate in the follicular phase of the menstrual cycle as determined by menstrual history and a negative pregnancy test will be recorded prior to participation
• BMI > 19 and < 35
• Age 18-30 Exclusion Criteria
• Smokers
• Unwilling or unable to abstain from alcohol consumption and caffeine consumption prior to testing and laboratory
• Significant renal, hepatic, endocrine, pulmonary, cardiac or hematological disease
• Pregnancy
• Corticosteroid use in previous two months
• Chronic use of anti-diabetic, anti-hypertensive, or other medications known to affect fat metabolism
• Use of Depo-Provera, hormone implants or estrogen replacement therapy
• Irregular menstrual cycles
• Post-menopausal women
• Weight gain or loss of > 3kg in the last 6 months

For the MRI, the following exclusion criteria apply:

• Individuals who have a heart pacemaker, defibrillator, or non-removable hearing aid
• Individuals with any clips or metal plates in their head
• Individuals who have any artificial limbs or prosthetic devices
• Individuals who were ever injured by a metallic foreign body which was not removed
• Individuals, who wear braces on their teeth, have non-removable false teeth, or removable bridgework

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DEXA Scanner	Low Fat Diet	Low-dose X0rays to determine the amount of fat, bone and muscle in your body.
Lifestyle	High Fat Diet	Measurement of body weight in a fown with light undercloting (30 minutes) and height.

Primary Outcome Measures

Name	Time	Method
Characteristics of Individuals	4 days of high fat diet	Characterize the biochemical, endocrine, anthropometric and environmental characteristics of individuals with the "thrifty" phenotype.

Secondary Outcome Measures

Name	Time	Method
Identify the Signaling Pathways	4 days after high fat diet	Identify the signaling pathways in skeletal muscle that are dysregulated in individuals with the "thrifty" phenotype through mRNA expression profiling in skeletal tissue.

Trial Locations

Locations (1)

Pennington Biomedical Research Center; 🇺🇸 Baton Rouge, Louisiana, United States