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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Dietary supplement: Low fat diet; Dietary supplement: High fat diet; Dietary supplement: MCT diet

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: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: 1; low fat diet for two weeks.	Dietary supplement: Low fat diet; 20% fat diet
ACTIVE_COMPARATOR: 2; High fat diet for two weeks followed by blood sampling.	Dietary supplement: High fat diet; 40% fat diet
ACTIVE_COMPARATOR: 3; Medium Chain Triglyceride diet	Dietary supplement: MCT diet; Medium chain triglyceride diet; Other Names: Medium chain triglyceride diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (ACTUAL): March 1, 2011
• Study Completion (ACTUAL): March 1, 2011

Study Registration Dates

• First Submitted: June 6, 2008
• First Submitted That Met QC Criteria: June 6, 2008
• First Posted (ESTIMATE): June 10, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): May 15, 2012
• Last Update Submitted That Met QC Criteria: May 14, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: eIRB 3224; OCTRI 1048 (OTHER: Oregon Clinical and Translational Research Institute); eIRB #3224 (OTHER: OHSU Institutional Review Board)