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

June 6, 2008
May 14, 2012
February 2008
March 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00694512 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Ghrelin Regulation and Structure: Effect of Diet Composition on Ghrelin
Ghrelin Regulation and Structure: Effect of Diet Composition on Ghrelin

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Obesity
  • Dietary Supplement: Low fat diet
    20% fat diet
    Other Name: low fat diet
  • Dietary Supplement: High fat diet
    40% fat diet
    Other Name: High fat diet
  • Dietary Supplement: MCT diet
    Medium chain triglyceride diet
    Other Name: Medium chain triglyceride diet
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
51
March 2011
March 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00694512
eIRB 3224, OCTRI 1048, eIRB #3224
No
Jonathan Q. Purnell, OHSU - Center for the Study of Weight Regulation
Oregon Health and Science University
Not Provided
Principal Investigator: Jonathan Q. Purnell, M.D. Oregon Health and Science University
Oregon Health and Science University
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP