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Ghrelin Regulation and Structure: Effect of Diet Composition on Ghrelin

This study has been completed.
Sponsor:
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00694512
First received: June 6, 2008
Last updated: May 14, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Obesity
Dietary Supplement: Low fat diet
Dietary Supplement: High fat diet
Dietary Supplement: MCT diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Ghrelin Regulation and Structure: Effect of Diet Composition on Ghrelin

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 51
Study Start Date: February 2008
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
low fat diet for two weeks.
Dietary Supplement: Low fat diet
20% fat diet
Other Name: low fat diet
Active Comparator: 2
High fat diet for two weeks followed by blood sampling.
Dietary Supplement: High fat diet
40% fat diet
Other Name: High fat diet
Active Comparator: 3
Medium Chain Triglyceride diet
Dietary Supplement: MCT diet
Medium chain triglyceride diet
Other Name: Medium chain triglyceride diet

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00694512

Locations
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Jonathan Q. Purnell, M.D. Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Jonathan Q. Purnell, OHSU - Center for the Study of Weight Regulation
ClinicalTrials.gov Identifier: NCT00694512     History of Changes
Other Study ID Numbers: eIRB 3224, OCTRI 1048, eIRB #3224
Study First Received: June 6, 2008
Last Updated: May 14, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on November 20, 2014