Ghrelin Regulation and Structure: Effect of Diet Composition on Ghrelin

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00694512

Enrollment

Registered

2008-06-10

Start date

2008-02-29

Completion date

2011-03-31

Last updated

2012-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

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.

Interventions

DIETARY_SUPPLEMENTLow fat diet

20% fat diet

DIETARY_SUPPLEMENTHigh fat diet

40% fat diet

DIETARY_SUPPLEMENTMCT diet

Medium chain triglyceride diet

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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. * 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

Design outcomes

Primary

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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026