Ghrelin Regulation and Structure: Effect of Diet Composition on Ghrelin
|Obesity||Dietary Supplement: Low fat diet Dietary Supplement: High fat diet Dietary Supplement: MCT diet|
|Study Design:||Allocation: Randomized
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|
- 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 ]
|Study Start Date:||February 2008|
|Study Completion Date:||March 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|