Mechanisms of the Effect of Physical Activity on the Adaptation to a High-Fat Diet
2 other identifiers
interventional
17
1 country
1
Brief Summary
The study is designed to determine the effect of high physical activity level vs. low physical activity level on the adaptation to a high fat diet.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy
Started May 2007
Longer than P75 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 28, 2008
CompletedFirst Posted
Study publicly available on registry
February 8, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedSeptember 21, 2022
January 1, 2016
1.8 years
January 28, 2008
September 16, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
One Year
Study Arms (2)
1
EXPERIMENTALHigh intensity exercise and high fat diet
2
EXPERIMENTALLow intensity exercise and high fat diet
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pennington Biomedical Research Centerlead
- University of Washingtoncollaborator
Study Sites (1)
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Steven Smith
Pennington Biomedical Research Center
- PRINCIPAL INVESTIGATOR
George Bray
Pennington Biomedical Research Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2008
First Posted
February 8, 2008
Study Start
May 1, 2007
Primary Completion
March 1, 2009
Study Completion
June 1, 2020
Last Updated
September 21, 2022
Record last verified: 2016-01