Ghrelin Regulation and Structure: Effect of Diet Composition on Ghrelin
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ClinicalTrials.gov Identifier: NCT00694512 |
Recruitment Status :
Completed
First Posted : June 10, 2008
Last Update Posted : May 15, 2012
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Sponsor:
Oregon Health and Science University
Information provided by:
Oregon Health and Science University
Tracking Information | ||||
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First Submitted Date ICMJE | June 6, 2008 | |||
First Posted Date ICMJE | June 10, 2008 | |||
Last Update Posted Date | May 15, 2012 | |||
Study Start Date ICMJE | February 2008 | |||
Actual Primary Completion Date | March 2011 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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 ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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 ] | |||
Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Ghrelin Regulation and Structure: Effect of Diet Composition on Ghrelin | |||
Official Title ICMJE | Ghrelin Regulation and Structure: Effect of Diet Composition on Ghrelin | |||
Brief 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. | |||
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. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
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Condition ICMJE | Obesity | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
51 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | March 2011 | |||
Actual Primary Completion Date | March 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00694512 | |||
Other Study ID Numbers ICMJE | eIRB 3224 OCTRI 1048 ( Other Identifier: Oregon Clinical and Translational Research Institute ) eIRB #3224 ( Other Identifier: OHSU Institutional Review Board ) |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Jonathan Q. Purnell, OHSU - Center for the Study of Weight Regulation | |||
Study Sponsor ICMJE | Oregon Health and Science University | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Oregon Health and Science University | |||
Verification Date | May 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |