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ADAPT The Adaptation to High Fat Diets Extention

ADAPT-The Adaptation to High Fat Diets

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00493701
Enrollment
72
Registered
2007-06-28
Start date
2016-07-31
Completion date
2020-03-04
Last updated
2022-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

BEHAVIORALHigh Fat Diet

Daily eating

BEHAVIORALLow Fat Diet

Life style eating habits

Sponsors

Pennington Biomedical Research Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Characteristics of Individuals4 days of high fat dietCharacterize the biochemical, endocrine, anthropometric and environmental characteristics of individuals with the thrifty phenotype.

Secondary

MeasureTime frameDescription
Identify the Signaling Pathways4 days after high fat dietIdentify the signaling pathways in skeletal muscle that are dysregulated in individuals with the thrifty phenotype through mRNA expression profiling in skeletal tissue.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026