Ghrelin Regulation and Structure: Effect of Diet Composition on Ghrelin

• ClinicalTrials.gov Identifier: NCT00694512
• Recruitment Status: Completed
• First Posted: June 10, 2008
• Last Update Posted: May 15, 2012
• Sponsor: Oregon Health and Science University
• Information provided by: Oregon Health and Science University

Tracking Information

• First Submitted Date: June 6, 2008
• First Posted Date: June 10, 2008
• Last Update Posted Date: May 15, 2012
• Study Start Date: February 2008
• Actual Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 6, 2008): 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: Same as current
• Current Secondary Outcome Measures (submitted: June 6, 2008): 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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Ghrelin Regulation and Structure: Effect of Diet Composition on Ghrelin
• Official Title: 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Basic Science
• Condition: Obesity

Intervention

• Dietary Supplement: Low fat diet
  20% fat diet
• Dietary Supplement: High fat diet
  40% fat diet
• Dietary Supplement: MCT diet
  Medium chain triglyceride diet
  Other Name: Medium chain triglyceride diet

Study Arms

• Placebo Comparator: 1
  low fat diet for two weeks.
  Intervention: Dietary Supplement: Low fat diet
• Active Comparator: 2
  High fat diet for two weeks followed by blood sampling.
  Intervention: Dietary Supplement: High fat diet
• Active Comparator: 3
  Medium Chain Triglyceride diet
  Intervention: Dietary Supplement: MCT diet

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 6, 2008): 51
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: March 2011
• Actual Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Age 18 or older.
• Weight stable for at least 3 months.
• At lifetime maximal body weight.

Exclusion Criteria:

• 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.
• 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00694512
• Other Study ID Numbers: eIRB 3224; OCTRI 1048 ( Other Identifier: Oregon Clinical and Translational Research Institute ); eIRB #3224 ( Other Identifier: OHSU Institutional Review Board )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Jonathan Q. Purnell, OHSU - Center for the Study of Weight Regulation
• Study Sponsor: Oregon Health and Science University
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jonathan Q. Purnell, M.D.; Oregon Health and Science University

• PRS Account: Oregon Health and Science University
• Verification Date: May 2012