"ADAPT" The Adaptation to High Fat Diets
Tracking Information | |||||
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First Received Date ICMJE | June 26, 2007 | ||||
Last Updated Date | July 19, 2011 | ||||
Start Date ICMJE | November 2010 | ||||
Estimated Primary Completion Date | January 2018 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Characterize the biochemical, endocrine, anthropometric and environmental characteristics of individuals with the "thrifty" phenotype. [ Time Frame: 4 days of high fat diet ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE |
Characterize the biochemical, endocrine, anthropometric and environmental characteristics of individuals with the “thrifty” phenotype. [ Time Frame: 4 days of high fat diet ] | ||||
Change History | Complete list of historical versions of study NCT00493701 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
Identify the signaling pathways in skeletal muscle that are dysregulated in individuals with the "thrifty" phenotype through mRNA expression profiling in skeletal tissue. [ Time Frame: 4 days after high fat diet ] [ Designated as safety issue: No ] | ||||
Original Secondary Outcome Measures ICMJE |
Identify the signaling pathways in skeletal muscle that are dysregulated in individuals with the “thrifty” phenotype through mRNA expression profiling in skeletal tissue. [ Time Frame: 4 days after high fat diet ] | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | "ADAPT" The Adaptation to High Fat Diets | ||||
Official Title ICMJE | ADAPT-The Adaptation to High Fat Diets | ||||
Brief Summary | This study is designed to predict weight gain overtime after a high fat diet. |
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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:
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Study Type ICMJE | Interventional | ||||
Study Phase | |||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Diagnostic |
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Condition ICMJE | Healthy | ||||
Intervention ICMJE |
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Study Arm (s) |
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Publications * | 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. Epub 2009 Feb 19. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE | 65 | ||||
Estimated Completion Date | November 2018 | ||||
Estimated Primary Completion Date | January 2018 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
For the MRI, the following exclusion criteria apply:
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Gender | Both | ||||
Ages | 18 Years to 30 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00493701 | ||||
Other Study ID Numbers ICMJE | PBRC21041 | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | George Bray, MD, Pennington Biomedical Research Center | ||||
Study Sponsor ICMJE | Pennington Biomedical Research Center | ||||
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Investigators ICMJE |
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Information Provided By | Pennington Biomedical Research Center | ||||
Verification Date | July 2011 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |