"ADAPT" The Adaptation to High Fat Diets Extention

September 13, 2022 updated by: Pennington Biomedical Research Center

ADAPT-The Adaptation to High Fat Diets

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

Study Overview

Status

Completed

Conditions

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

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Pennington Biomedical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Other: Lifestyle
Measurement of body weight in a fown with light undercloting (30 minutes) and height.
Daily eating
Other Names:
  • Measurements will be collected to help with gathering data.
Other: DEXA Scanner
Low-dose X0rays to determine the amount of fat, bone and muscle in your body.
Life style eating habits
Other Names:
  • Questionnairs of food frequency

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.
4 days of high fat diet

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

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

March 4, 2020

Study Completion (Actual)

March 4, 2020

Study Registration Dates

First Submitted

June 26, 2007

First Submitted That Met QC Criteria

June 26, 2007

First Posted (Estimate)

June 28, 2007

Study Record Updates

Last Update Posted (Actual)

September 15, 2022

Last Update Submitted That Met QC Criteria

September 13, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • PBRC 21041

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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