- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00123240
High Carbohydrate vs. High Fat Diets in the Treatment of Obesity (JBR 0512)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Participation in this study requires 2 screening visits to the outpatient clinic, and if participants qualify, 10 inpatient study weeks.
Subjects will be admitted to the Rockefeller University Hospital for the 10 week in-patient phase of the study. The first 2 weeks consist of a weight stabilization period, during which subjects will be required to consume an average American diet. This is followed by the 6 week weight loss period where subjects will be randomized to either a low calorie high carbohydrate or a low calorie high fat/protein diet. On both diets there will be a 50% calorie deficit compared to the weight stabilization period. This will be followed by a 2 week weight maintenance period during which calories will be added to the diet to maintain the new weight. Appropriate adjustments will be made to keep the subject's weight stable.
During the entire inpatient study, subjects will consume one multivitamin per day (Centrum, always complete, from A to Zinc) and one iron supplement per day. In addition, unlimited access to zero calorie liquids (water/diet soda) will be available and will be encouraged to maintain one's usual activity level.
Females of reproductive age, need to make sure that they do not become pregnant during the inpatient study. Urine will be tested for pregnancy once during the stabilization and weight maintenance phases of the study.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10021
- Rockefeller University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Man or a woman with a body mass index (BMI) of 30 to 34.9
- Man with a BMI of 25 to 29.9 with a waist circumference > 102cm (40in)
- Woman with a BMI of 25 to 29.9 with a waist circumference > 88cm (35in)
Exclusion Criteria:
- High Blood Pressure
- High Cholesterol
- Diabetes
- HIV positive
- Syphilis
- Hepatitis B/C positive
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: High Fat/Protein Diet
|
High Fat/Protein Diet: 10% carbohydrate, 25% protein, 65% fat (26% SFA, 25% MFA, 9% PUFA), P/S 0.33, 458 mg cholesterol/1500 kcal
|
Active Comparator: High Carbohydrate Diet
|
65% carbohydrate, 15% protein, 20% fat (7% SFA, 8% MFA, 4% PUFA), P/S 0.63, 152 mg cholesterol/1500 kcal
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Visceral adipose tissue
Time Frame: days 12, 68
|
days 12, 68
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Body composition
Time Frame: days 12, 68
|
days 12, 68
|
Blood pressure
Time Frame: days 11 and 67
|
days 11 and 67
|
Insulin glucose metabolism
Time Frame: days 13, 15 69, 71
|
days 13, 15 69, 71
|
Bone turnover
Time Frame: days 14, 70
|
days 14, 70
|
Measures of satiety
Time Frame: once a week
|
once a week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jan L. Breslow, MD, Rockefeller University
Publications and helpful links
Helpful Links
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- JBR-0512
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.
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