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Completed

NCT Number: NCT00694512

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Health & Science University

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low fat diet

Dietary Supplement

20% fat diet

High Fat Diet

Dietary Supplement

40% fat diet

MCT Diet

Dietary Supplement

Medium chain triglyceride diet

Other names: Medium chain triglyceride diet

Primary outcomes

  1. 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.

    Time frame: every 8 weeks

Secondary outcomes

  1. 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.

    Time frame: Every 8 weeks

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jun 10, 2008
Registry last updated
May 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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