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
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Dietary Supplement: Low fat diet Dietary Supplement: High fat diet Dietary Supplement: MCT diet||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||51 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Ghrelin Regulation and Structure: Effect of Diet Composition on Ghrelin|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||March 2011|
Placebo Comparator: 1
low fat diet for two weeks.
Dietary Supplement: Low fat diet
20% fat diet
Active Comparator: 2
High fat diet for two weeks followed by blood sampling.
Dietary Supplement: High fat diet
40% fat diet
Active Comparator: 3
Medium Chain Triglyceride diet
Dietary Supplement: MCT diet
Medium chain triglyceride diet
Other Name: Medium chain triglyceride diet
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00694512
|United States, Oregon|
|Oregon Health & Science University|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||Jonathan Q. Purnell, M.D.||Oregon Health and Science University|