HealthyNCT00611117
Mechanisms of the Effect of Physical Activity on the Adaptation to a High-Fat Diet
A study testing Physical Activity Level in people with Healthy, run by Pennington Biomedical Research Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Physical Activity Level
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 26Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
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.
Read the 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
- Conditions
- Healthy
- Being tested
- Physical Activity Level
- Keywords
- adaptation to high fat diet, activity, exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Activity LevelOther
High vs. low physical activity during a high fat diet consumption.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | High intensity exercise and high fat diet Receives: Other: Physical Activity Level |
| 2 | Experimental | Low intensity exercise and high fat diet Receives: Other: Physical Activity Level |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2008 (estimated)
- Study startMay 2007
- Primary completionMar 2009
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington
- Responsible party
- Sponsor
- Investigators
- Steven Smith, Principal investigator, Pennington Biomedical Research CenterGeorge Bray, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00611117
- Sponsor's protocol ID
- PBRC 27017
- Other IDs
- 58-6535-5-071
- Status last verified
- Jan 2016
- First submitted
- 28 Jan 2008
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of the Effect of Physical Activity on the Adaptation to a High-Fat Diet
- ClinicalTrials.gov ID
- NCT00611117
- Acronym / sponsor ID
- PBRC 27017
- Conditions
- Healthy
- Keywords
- adaptation to high fat diet, activity, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- University of Washington
- Study start
- May 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 8 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Physical Activity LevelHigh intensity exercise and high fat diet |
| 2 | Experimental | Other: Physical Activity LevelLow intensity exercise and high fat diet |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical Activity LevelHigh vs. low physical activity during a high fat diet consumption. | Other | 1, 2 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Smith principal investigator
Pennington Biomedical Research Center
George Bray principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity Level in people with Healthy, run by Pennington Biomedical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2022.