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. We 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
Overweight, Obesity	Behavior: Failure to adhere to prescribed diet

Further Study Details: 

Primary Outcomes: Visceral adipose tissue
Secondary Outcomes: Body composition, blood pressure, insulin glucose metabolism, bone turnover, measures of satiety, arterial compliance
Expected Total Enrollment:  50

Your participation in this study requires 2 screening visits to the outpatient clinic, and if you qualify, 16 inpatient study weeks.

You will be admitted to the Rockefeller University Hospital for the 16 week in-patient phase of the study. The first 3 weeks consist of a weight stabilization period, during which you will be required to consume an average American diet. This is followed by the weight loss period where you 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 40% calorie deficit compared to the weight stabilization period. This will be followed by a 3 week weight maintenance period during which calories will be added to your diet to maintain you at your new weight. Appropriate adjustments will be made to keep your weight stable.

During the entire inpatient study, you will consume one multivitamin per day(Centrum, always complete, from A to Zinc). In addition, you will have unlimited access to zero calorie liquids (water/diet soda) and will be encouraged to maintain your usual activity level.

If you are female of reproductive age, you need to make sure that you do not become pregnant during the inpatient. Your urine will be tested for pregnancy once during the stabilization and weight maintenance phases of the study.

Ages Eligible for Study:  30 Years   -   50 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00123240

Jill Culiner, NP      212-327-7445    culinej@rockefeller.edu

New York
      Rockefeller University, New York,  New York,  10021,  United States; Recruiting

Study chairs or principal investigators

Jan L. Breslow, MD,  Principal Investigator,  Rockefeller University   

Study ID Numbers:  JBR 512
Record last reviewed:  July 2005
Last Updated:  July 25, 2005
Record first received:  July 21, 2005
ClinicalTrials.gov Identifier:  NCT00123240
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-07-26