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| Sponsors and Collaborators: |
Rockefeller University St. Luke's-Roosevelt Hospital Center |
|---|---|
| Information provided by: | Rockefeller University |
| ClinicalTrials.gov Identifier: | NCT00299273 |
Purpose
The purpose of this study is to examine the effects of a low calorie high fat/protein diet on body fat and body composition in overweight and obese subjects. The investigators will also test the effects of this diet on secondary outcomes such as: fluid and electrolyte balance, cholesterol, inflammation, sugar and insulin metabolism, fat hormones, blood pressure and feelings of fullness.
| Condition | Intervention |
|---|---|
|
Obesity |
Behavioral: Low calorie high fat/protein diet |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study |
| Official Title: | Exploratory Feasibility Study: High Fat/Protein Diet in the Treatment of Obesity |
| Estimated Enrollment: | 7 |
| Study Start Date: | March 2006 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| high fat/protein diet: Experimental |
Behavioral: Low calorie high fat/protein diet
6 weeks of caloric restriction (50%) on a high fat/protein diet
|
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 eat an average American diet. This is followed by the 6 week weight loss period where subjects will be put on a low calorie high fat/protein diet. During the weight loss period, calories will be cut by 50% 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 subjects will be encouraged to maintain their 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 each phase of the study.
Eligibility| Ages Eligible for Study: | 25 Years to 50 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Caryne Roey | 800-RU-CARES | croey@rockefeller.edu |
| United States, New York | |
| The Rockefeller University Hospital | |
| New York, New York, United States, 10021 | |
| Principal Investigator: | Jan L. Breslow, MD | The Rockefeller University Hospital |
More Information
| Responsible Party: | Rockefeller University ( Jan Breslow ) |
| Study ID Numbers: | RUH IRB # JBR-0583 |
| Study First Received: | March 2, 2006 |
| Last Updated: | March 23, 2009 |
| ClinicalTrials.gov Identifier: | NCT00299273 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Obesity; Low calorie high fat/protein diet; Low-carbohydrate diet Weight Loss |
|
Body Weight Signs and Symptoms Obesity Weight Loss |
Nutrition Disorders Overweight Overnutrition |
|
Body Weight Signs and Symptoms Obesity |
Nutrition Disorders Overweight Overnutrition |
