Ghrelin Regulation and Structure: Effect of Diet Composition on Ghrelin

Oregon Health & Science University (OHSU)

Status: Completed

Conditions: Obesity

Treatments: Dietary Supplement: Low fat diet; Dietary Supplement: High fat diet; Dietary Supplement: MCT diet

Study type: Interventional

Funder types: Other

Identifiers

NCT00694512

eIRB #3224 (Other Identifier)

eIRB 3224

OCTRI 1048 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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51 participants in 3 patient groups, including a placebo group

1

Placebo Comparator group

Description:

low fat diet for two weeks.

Treatment:

Dietary Supplement: Low fat diet

2

Active Comparator group

Description:

High fat diet for two weeks followed by blood sampling.

Treatment:

Dietary Supplement: High fat diet

3

Active Comparator group

Description:

Medium Chain Triglyceride diet

Treatment:

Dietary Supplement: MCT diet