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| Sponsors and Collaborators: |
Rockefeller University St. Luke's-Roosevelt Hospital Center |
|---|---|
| Information provided by: | Rockefeller University |
| ClinicalTrials.gov Identifier: | NCT00123240 |
Purpose
The purpose of this study is to compare the ability of low calorie high carbohydrate and low calorie high fat/protein diets to decrease abdominal fat in overweight and obese subjects. The investigators will also test the effects of these diets on secondary outcomes including body composition, fluid and electrolyte balance, lipids and lipoproteins, blood pressure, arterial compliance, glucose and insulin metabolism, bone turnover, and measures of satiety.
| Condition | Intervention |
|---|---|
|
Obesity |
Behavioral: Low calorie high carbohydrate diet Behavioral: Low calorie high fat/protein diet |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Uncontrolled, Parallel Assignment, Efficacy Study |
| Official Title: | High Carbohydrate vs. High Fat Diets in the Treatment of Obesity (JBR 0512) |
| Estimated Enrollment: | 50 |
| Study Start Date: | July 2004 |
| Estimated Study Completion Date: | August 2007 |
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.
Eligibility| Ages Eligible for Study: | 30 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, New York | |
| Rockefeller University | |
| New York, New York, United States, 10021 | |
| Principal Investigator: | Jan L. Breslow, MD | Rockefeller University |
More Information
| Study ID Numbers: | JBR 512 |
| Study First Received: | July 19, 2005 |
| Last Updated: | July 17, 2007 |
| ClinicalTrials.gov Identifier: | NCT00123240 |
| Health Authority: | United States: Institutional Review Board |
|
overweight obese diet |
|
Body Weight Signs and Symptoms Obesity |
Nutrition Disorders Overnutrition Overweight |
