Ghrelin Regulation and Structure: Effect of Diet Composition on Ghrelin

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Dietary Supplement: Low fat diet; Dietary Supplement: High fat diet; Dietary Supplement: MCT diet

• Registration Number: NCT00694512
• Lead Sponsor: Oregon Health and Science University

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 Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-06-06
• Study First Submitted QC: 2008-06-06
• Study First Posted: 2008-06-10
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-14
• Last Update Posted: 2012-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Low fat diet	low fat diet for two weeks.
2	High fat diet	High fat diet for two weeks followed by blood sampling.
3	MCT diet	Medium Chain Triglyceride diet

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States