- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00611117
Mechanisms of the Effect of Physical Activity on the Adaptation to a High-Fat Diet
Study Overview
Detailed Description
A high fat diet is linked to weight gain and obesity. An adjustment to the acute exposure to high fat diet is not abrupt and takes time. In a previous study from our laboratory, it has been shown that high level of physical activity can accelerate the adaptation to a high fat diet by increasing fat oxidation. In this study we will determine the mechanism involved in this adjustment. Our hypotheses are:
- High fat diets decrease skeletal muscle glucose metabolism and decrease mitochondrial biogenesis through the upregulation of PDK4 and downregulation of PGC1α; increased physical activity will prevent these deleterious effects.
- A high fat diet will increase hepatic and skeletal muscle lipid; increased physical activity will prevent these deleterious effects.
- These effects are more pronounced in individuals with a low mitochondrial content
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Louisiana
-
Baton Rouge, Louisiana, United States, 70808
- Pennington Biomedical Research Center
-
-
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
- BMI > 19 and < 35 kg/m2
- Age 18-35
- 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
- Willing and able to walk on a treadmill at a pace of 3 mph at 3%grade for 3-4 hours/day for 3 consecutive days
- Willing to eat only and all foods provided by Pennington for 9 days on 2 occasions (18 days)
- Willing to stop alcohol consumption for the duration of the study
- Able come to Pennington for meals and tests for 20 days 12 of these inpatient.
Exclusion Criteria:
- Significant renal, hepatic, endocrine, pulmonary, cardiac or hematological disease (for the consent form you will have to use kidney, liver, etc )
- You abuse alcohol or illegal drugs or are unable to avoid alcohol or caffeine prior to testing
- Smokers
- Unable or unlikely to eat all and only food provided by the PBRC metabolic kitchen.
- Pregnant or planning to become pregnant
- 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
- Unable or unwilling to perform treadmill walking at the required speed and incline to achieve 1.8*RMR
- History or family history of blood clots deep vein thrombosis or pulmonary embolism)
- Poor circulation, bypass operation on legs, blood coagulation disorders, diagnosed peripheral arterial or vascular disease, cramping pain in your muscle during exercise or nerve damage in your legs.
- You had major surgery on the abdomen, pelvis or legs within previous 3 months.
- You have cancer
- You have rheumatoid disease/ walking or joint problems
- You are claustrophobic
- You are depressed or have an eating disorder
- You demonstrate a style of interpersonal relationships that would inhibit successful completion of the study
For the MRS / 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 with bridgework held in place by magnets
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
High intensity exercise and high fat diet
|
High vs. low physical activity during a high fat diet consumption.
|
|
Experimental: 2
Low intensity exercise and high fat diet
|
High vs. low physical activity during a high fat diet consumption.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To determine the effects of a high fat diet [at both low and high physical activity] on • Sk muscle PGC1α and PDK4 mRNA and protein • Glucose oxidation • Fatty acid oxidation • Hepatic and skeletal muscle lipid • VO2 max • Mitochondr
Time Frame: One Year
|
One Year
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Steven Smith, Pennington Biomedical Research Center
- Principal Investigator: George Bray, Pennington Biomedical Research Center
Study record dates
Study Major Dates
Study Start
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
Keywords
Other Study ID Numbers
- PBRC 27017
- 58-6535-5-071
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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