Ghrelin Regulation and Structure: Effect of Diet Composition on Ghrelin
3 other identifiers
interventional
51
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable obesity
Started Feb 2008
Typical duration for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 6, 2008
CompletedFirst Posted
Study publicly available on registry
June 10, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedMay 15, 2012
May 1, 2012
3.1 years
June 6, 2008
May 14, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
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.
every 8 weeks
Secondary Outcomes (1)
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.
Every 8 weeks
Study Arms (3)
1
PLACEBO COMPARATORlow fat diet for two weeks.
2
ACTIVE COMPARATORHigh fat diet for two weeks followed by blood sampling.
3
ACTIVE COMPARATORMedium Chain Triglyceride diet
Interventions
Medium chain triglyceride diet
Eligibility Criteria
You may qualify if:
- Age 18 or older.
- Weight stable for at least 3 months.
- At lifetime maximal body weight.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oregon Health & Science University
Portland, Oregon, 97239, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathan Q. Purnell, M.D.
Oregon Health and Science University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 6, 2008
First Posted
June 10, 2008
Study Start
February 1, 2008
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
May 15, 2012
Record last verified: 2012-05