Ghrelin Regulation and Structure: Effect of Diet Composition on Ghrelin
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 51
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
- •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
Arms & Interventions
1
low fat diet for two weeks.
Intervention: Low fat diet (Dietary Supplement)
2
High fat diet for two weeks followed by blood sampling.
Intervention: High fat diet (Dietary Supplement)
3
Medium Chain Triglyceride diet
Intervention: MCT diet (Dietary Supplement)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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)