- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00493701
"ADAPT" The Adaptation to High Fat Diets Extention
ADAPT-The Adaptation to High Fat Diets
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Louisiana
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Baton Rouge, Louisiana, United States, 70808
- Pennington Biomedical Research Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Other: Lifestyle
Measurement of body weight in a fown with light undercloting (30 minutes) and height.
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Daily eating
Other Names:
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Other: DEXA Scanner
Low-dose X0rays to determine the amount of fat, bone and muscle in your body.
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Life style eating habits
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Characteristics of Individuals
Time Frame: 4 days of high fat diet
|
Characterize the biochemical, endocrine, anthropometric and environmental characteristics of individuals with the "thrifty" phenotype.
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4 days of high fat diet
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Identify the Signaling Pathways
Time Frame: 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.
|
4 days after high fat diet
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PBRC 21041
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