ObesityNCT00694512
Ghrelin Regulation and Structure: Effect of Diet Composition on Ghrelin
A study testing Low fat diet, High fat diet and MCT diet in people with Obesity, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The purpose of this study is to learn more about how diet affects the hormone ghrelin. Ghrelin is made in the stomach and causes appetite to increase. Learning about ghrelin will help the investigators understand more about obesity. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Low fat diet, High fat diet and MCT diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Mar 2011
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 or older.
- Weight stable for at least 3 months.
- At lifetime maximal body weight.
Who cannot join
- Actively losing weight by diet or exercise.
- Smokers.
- Alcohol consumption > 2 drinks per day.
- Exercise > 30 minutes 3 times a week.
- Prescription drug use (except birth control pills, vitamins, or minerals).
- Type 2 diabetes.
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- Heart disease, cancer, malabsorptive states, or chronic infections that would affect body weight.
- Weight > 300 lbs (exceeds the weight limit of the DEXA machine).
- Hemoglobin < 12.0 g/dL for women, < 13.5 g/dL for men
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
The purpose of this study is to learn more about how diet affects the hormone ghrelin. Ghrelin is made in the stomach and causes appetite to increase. Learning about ghrelin will help the investigators understand more about obesity.
Read the detailed description
Control subjects will be provided 3 different diets for 2 weeks each. At the end of each diet period participants will be admitted to OHSU Clinical Translation Research Center (CTRC) for blood sampling every 30 minutes for 13.5 hours, to measure levels of hormones. Participants will also have a DXA scan to measure body composition.
PWS subjects will have one admission after eating a standardized diet prepared by caregivers for 2 weeks.
- Conditions
- Obesity
- Being tested
- Low fat diet, High fat diet, MCT diet
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low fat dietDietary supplement
20% fat diet
High fat dietDietary supplement
40% fat diet
MCT dietDietary supplement
Also called Medium chain triglyceride diet
Medium chain triglyceride diet
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | low fat diet for two weeks. Receives: Dietary Supplement: Low fat diet |
| 2 | Active comparator | High fat diet for two weeks followed by blood sampling. Receives: Dietary Supplement: High fat diet |
| 3 | Active comparator | Medium Chain Triglyceride diet Receives: Dietary Supplement: MCT diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcomes for aim 1 are the suppression of total and acylated ghrelin from peak fasting (highest value) level to nadir (lowest level) during the 4 hours after each meal, comparing the obese to the lean subjects.
Measured: every 8 weeks
Secondary outcomes (1)
Area-under-the-curve measurements during the 12 ½ hours of testing for ghrelin and other nutrient and gut-peptides, including glucose, insulin, PYY3-36, and active GLP-1.
Measured: Every 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2008 (estimated)
- Study startFeb 2008
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Investigators
- Jonathan Q. Purnell, M.D., Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00694512
- Sponsor's protocol ID
- eIRB 3224
- Other IDs
- OCTRI 1048, eIRB #3224
- Status last verified
- May 2012
- First submitted
- 6 Jun 2008
- Last updated
- 15 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ghrelin Regulation and Structure: Effect of Diet Composition on Ghrelin
- ClinicalTrials.gov ID
- NCT00694512
- Acronym / sponsor ID
- eIRB 3224
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 10 Jun 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 purpose of this study is to learn more about how diet affects the hormone ghrelin. Ghrelin is made in the stomach and causes appetite to increase. Learning about ghrelin will help the investigators understand more about obesity.
Detailed description
Control subjects will be provided 3 different diets for 2 weeks each. At the end of each diet period participants will be admitted to OHSU Clinical Translation Research Center (CTRC) for blood sampling every 30 minutes for 13.5 hours, to measure levels of hormones. Participants will also have a DXA scan to measure body composition.
PWS subjects will have one admission after eating a standardized diet prepared by caregivers for 2 weeks.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Dietary Supplement: Low fat dietlow fat diet for two weeks. |
| 2 | Active comparator | Dietary Supplement: High fat dietHigh fat diet for two weeks followed by blood sampling. |
| 3 | Active comparator | Dietary Supplement: MCT dietMedium Chain Triglyceride diet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 or older.
- Weight stable for at least 3 months.
- At lifetime maximal body weight.
Key exclusion criteria (9 listed)
- Actively losing weight by diet or exercise.
- Smokers.
- Alcohol consumption > 2 drinks per day.
- Exercise > 30 minutes 3 times a week.
- Prescription drug use (except birth control pills, vitamins, or minerals).
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 |
|---|---|---|
| Low fat diet20% fat diet | Dietary supplement | 1 |
| High fat diet40% fat diet | Dietary supplement | 2 |
| MCT dietAlso: Medium chain triglyceride dietMedium chain triglyceride diet | Dietary supplement | 3 |
Primary outcome
The primary outcomes for aim 1 are the suppression of total and acylated ghrelin from peak fasting (highest value) level to nadir (lowest level) during the 4 hours after each meal, comparing the obese to the lean subjects.
Time frame: every 8 weeks
1 secondary outcome
Area-under-the-curve measurements during the 12 ½ hours of testing for ghrelin and other nutrient and gut-peptides, including glucose, insulin, PYY3-36, and active GLP-1.
Time frame: Every 8 weeks
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 May 2012.
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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.
Jonathan Q. Purnell, M.D. principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low fat diet, High fat diet and MCT diet in people with Obesity, run by Oregon Health and Science University 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 3 inclusion and 9 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 May 2012. 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. Some participants in this study may receive a placebo. 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?
The primary outcomes for aim 1 are the suppression of total and acylated ghrelin from peak fasting (highest value) level to nadir (lowest level) during the 4 hours after each meal, comparing the obese to the lean subjects. (time frame: every 8 weeks). 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 15 May 2012.