HealthyNCT00493701
"ADAPT" The Adaptation to High Fat Diets Extention
A study testing High Fat Diet and Low Fat Diet in people with Healthy, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
This study is designed to predict weight gain overtime after a high fat diet. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- High Fat Diet and Low Fat Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to 4 Mar 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 20Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: ADAPT-The Adaptation to High Fat Diets
This study is designed to predict weight gain overtime after a high fat diet.
Read the 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.
- Conditions
- Healthy
- Being tested
- High Fat Diet, Low Fat Diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Fat DietBehavioural
Also called Measurements will be collected to help with gathering data.
Daily eating
Low Fat DietBehavioural
Also called Questionnairs of food frequency
Life style eating habits
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle | Other | Measurement of body weight in a fown with light undercloting (30 minutes) and height. Receives: Behavioral: High Fat Diet |
| DEXA Scanner | Other | Low-dose X0rays to determine the amount of fat, bone and muscle in your body. Receives: Behavioral: Low Fat Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characteristics of Individuals
Characterize the biochemical, endocrine, anthropometric and environmental characteristics of individuals with the "thrifty" phenotype.
Measured: 4 days of high fat diet
Secondary outcomes (1)
Identify the Signaling Pathways
Identify the signaling pathways in skeletal muscle that are dysregulated in individuals with the "thrifty" phenotype through mRNA expression profiling in skeletal tissue.
Measured: 4 days after high fat diet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2007 (estimated)
- Study startJul 2016
- Primary completion4 Mar 2020
- Study completion4 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven R Smith, M.D., Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00493701
- Sponsor's protocol ID
- PBRC 21041
- Status last verified
- Sep 2022
- First submitted
- 26 Jun 2007
- Last updated
- 15 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lam YY, Redman LM, Smith SR, Bray GA, Greenway FL, Johannsen D, Ravussin E. Determinants of sedentary 24-h energy expenditure: equations for energy prescription and adjustment in a respiratory chamber. Am J Clin Nutr. 2014 Apr;99(4):834-42. doi: 10.3945/ajcn.113.079566. Epub 2014 Feb 5.
PubMed 24500151Pasarica M, Xie H, Hymel D, Bray G, Greenway F, Ravussin E, Smith SR. Lower total adipocyte number but no evidence for small adipocyte depletion in patients with type 2 diabetes. Diabetes Care. 2009 May;32(5):900-2. doi: 10.2337/dc08-2240. Epub 2009 Feb 19.
PubMed 19228873
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ADAPT-The Adaptation to High Fat Diets
- ClinicalTrials.gov ID
- NCT00493701
- Acronym / sponsor ID
- PBRC 21041
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- 4 Mar 2020 (actual)
- Study completion
- 4 Mar 2020 (actual)
- First posted
- 28 Jun 2007 (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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle | Other | Behavioral: High Fat DietMeasurement of body weight in a fown with light undercloting (30 minutes) and height. |
| DEXA Scanner | Other | Behavioral: Low Fat DietLow-dose X0rays to determine the amount of fat, bone and muscle in your body. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (20 listed)
- 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
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| High Fat DietAlso: Measurements will be collected to help with gathering data.Daily eating | Behavioural | Lifestyle |
| Low Fat DietAlso: Questionnairs of food frequencyLife style eating habits | Behavioural | DEXA Scanner |
Primary outcome
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.
1 secondary outcome
Identify the Signaling Pathways
Time frame: 4 days after high fat diet
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 15 Sep 2022.
- Derived from this study: PubMed 24500151Lam YY, Redman LM, Smith SR, Bray GA, Greenway FL, Johannsen D, Ravussin E. Determinants of sedentary 24-h energy expenditure: equations for energy prescription and adjustment in a respiratory chamber. Am J Clin Nutr. 2014 Apr;99(4):834-42. doi: 10.3945/ajcn.113.079566. Epub 2014 Feb 5.
- Derived from this study: PubMed 19228873Pasarica M, Xie H, Hymel D, Bray G, Greenway F, Ravussin E, Smith SR. Lower total adipocyte number but no evidence for small adipocyte depletion in patients with type 2 diabetes. Diabetes Care. 2009 May;32(5):900-2. doi: 10.2337/dc08-2240. Epub 2009 Feb 19.
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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 R Smith, M.D. 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 High Fat Diet and Low Fat Diet 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 20 inclusion and 0 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 15 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?
Characteristics of Individuals (time frame: 4 days of high fat diet). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00493701, which also lists 2 linked publications.
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 15 Sep 2022.