- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00694512
Ghrelin Regulation and Structure: Effect of Diet Composition on Ghrelin
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Oregon
-
Portland, Oregon, United States, 97239
- Oregon Health & Science University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: 1
low fat diet for two weeks.
|
20% fat diet
|
ACTIVE_COMPARATOR: 2
High fat diet for two weeks followed by blood sampling.
|
40% fat diet
|
ACTIVE_COMPARATOR: 3
Medium Chain Triglyceride diet
|
Medium chain triglyceride diet
Other Names:
|
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.
Time Frame: every 8 weeks
|
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.
Time Frame: Every 8 weeks
|
Every 8 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
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)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
Fundació Sant Joan de DéuNot yet recruitingObesity, Childhood | Obesity, AdolescentSpain
-
Consorcio Centro de Investigación Biomédica en...Maimónides Biomedical Research Institute of Córdoba; Instituto de Salud Carlos... and other collaboratorsActive, not recruiting
-
University of HoustonBaylor College of MedicineCompleted
Clinical Trials on Low fat diet
-
Rutgers, The State University of New JerseyCompleted
-
Maastricht University Medical CenterCompleted
-
Zhejiang UniversityNational Natural Science Foundation of China; Chinese PLA General Hospital; National...Completed
-
Laval UniversityRecruiting
-
Tufts UniversityCompletedDyslipidemia | Impaired Glucose Tolerance
-
Oregon Health and Science UniversityNational Institutes of Health (NIH)Recruiting
-
Hvidovre University HospitalUniversity of Copenhagen; Danish Research Centre for Magnetic ResonanceCompletedDiabetes | Metabolic Syndrome | NAFLD | Overweight and ObesityDenmark
-
UCSF Benioff Children's Hospital OaklandNational Cattlemen's Beef AssociationCompletedHealthy | Cardiovascular Disease | Atherogenic DyslipidemiaUnited States
-
University of Texas Southwestern Medical CenterTakeda; National Institutes of Health (NIH); Amylin Pharmaceuticals, LLC.CompletedDiabetes | Insulin Resistance | Hypertriglyceridemia | Hepatic SteatosisUnited States
-
University of NottinghamMars, Inc.Completed