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Ghrelin Regulation and Structure: Effect of Diet Composition on Ghrelin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00694512
Recruitment Status : Completed
First Posted : June 10, 2008
Last Update Posted : May 15, 2012
Sponsor:
Information provided by:
Oregon Health and Science University

Tracking Information
First Submitted Date  ICMJE June 6, 2008
First Posted Date  ICMJE June 10, 2008
Last Update Posted Date May 15, 2012
Study Start Date  ICMJE February 2008
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ghrelin Regulation and Structure: Effect of Diet Composition on Ghrelin
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Obesity
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 6, 2008)
51
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00694512
Other Study ID Numbers  ICMJE 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  ICMJE Not Provided
Responsible Party Jonathan Q. Purnell, OHSU - Center for the Study of Weight Regulation
Study Sponsor  ICMJE Oregon Health and Science University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jonathan Q. Purnell, M.D. Oregon Health and Science University
PRS Account Oregon Health and Science University
Verification Date May 2012

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