Ghrelin Regulation and Structure: Effect of Diet Composition on Ghrelin

NCT ID: NCT00694512

Last Updated: 2012-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2011-03-31

Brief Summary

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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

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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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

low fat diet for two weeks.

Group Type PLACEBO_COMPARATOR

Low fat diet

Intervention Type DIETARY_SUPPLEMENT

20% fat diet

2

High fat diet for two weeks followed by blood sampling.

Group Type ACTIVE_COMPARATOR

High fat diet

Intervention Type DIETARY_SUPPLEMENT

40% fat diet

3

Medium Chain Triglyceride diet

Group Type ACTIVE_COMPARATOR

MCT diet

Intervention Type DIETARY_SUPPLEMENT

Medium chain triglyceride diet

Interventions

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Low fat diet

20% fat diet

Intervention Type DIETARY_SUPPLEMENT

High fat diet

40% fat diet

Intervention Type DIETARY_SUPPLEMENT

MCT diet

Medium chain triglyceride diet

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Medium chain triglyceride diet

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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OHSU - Center for the Study of Weight Regulation

Principal Investigators

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Jonathan Q. Purnell, M.D.

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

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Oregon Health & Science University

Portland, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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OCTRI 1048

Identifier Type: OTHER

Identifier Source: secondary_id

eIRB #3224

Identifier Type: OTHER

Identifier Source: secondary_id

eIRB 3224

Identifier Type: -

Identifier Source: org_study_id

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