"ADAPT" The Adaptation to High Fat Diets Extention

NCT ID: NCT00493701

Last Updated: 2022-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2020-03-04

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

Lifestyle

Measurement of body weight in a fown with light undercloting (30 minutes) and height.

Group Type: OTHER

High Fat Diet

Intervention Type: BEHAVIORAL

Daily eating

DEXA Scanner

Low-dose X0rays to determine the amount of fat, bone and muscle in your body.

Group Type: OTHER

Low Fat Diet

Intervention Type: BEHAVIORAL

Life style eating habits

Interventions

High Fat Diet

Daily eating

Intervention Type: BEHAVIORAL

Low Fat Diet

Life style eating habits

Intervention Type: BEHAVIORAL

Other Intervention Names

Measurements will be collected to help with gathering data.; Questionnairs of food frequency

Eligibility Criteria

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

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pennington Biomedical Research Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven R Smith, M.D.

Role: PRINCIPAL_INVESTIGATOR

Pennington Biomedical Research Center

Locations

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Countries

United States

References

Lam YY, Redman LM, Smith SR, Bray GA, Greenway FL, Johannsen D, Ravussin E. Determinants of sedentary 24-h energy expenditure: equations for energy prescription and adjustment in a respiratory chamber. Am J Clin Nutr. 2014 Apr;99(4):834-42. doi: 10.3945/ajcn.113.079566. Epub 2014 Feb 5.

Reference Type: DERIVED

PMID: 24500151 (View on PubMed)

Pasarica M, Xie H, Hymel D, Bray G, Greenway F, Ravussin E, Smith SR. Lower total adipocyte number but no evidence for small adipocyte depletion in patients with type 2 diabetes. Diabetes Care. 2009 May;32(5):900-2. doi: 10.2337/dc08-2240. Epub 2009 Feb 19.

Reference Type: DERIVED

PMID: 19228873 (View on PubMed)

Other Identifiers

PBRC 21041

Identifier Type: -

Identifier Source: org_study_id