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(JBR-0512) High Carbohydrate vs. High Fat Diets in the Treatment of Obesity


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High Carbohydrate vs. High Fat Diets in the Treatment of Obesity (JBR-0512)

Principal Investigator:
Jan L. Breslow M.D.

Investigators:
Jan L. Breslow M.D.

Contact Information:
Clinical Research Support Office
Rockefeller University
1230 York Avenue
New York, NY 10021
Telephone: 1-800-RU-CARES
Email: rucares@rockefeller.edu
Enrollment Status:
Closed to Enrollment

Brief Summary of Protocol:
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.

If you join the research study, you will take part for 10 weeks as an inpatient.

We will try to accommodate your schedules if you work or attend school. If you have some flexibility and fit the medical criteria of the study, it can be compatible.



Detailed Description of Protocol:
Your participation in this study requires 2 screening visits to the outpatient clinic, and if you qualify, 10 inpatient study weeks.

You will be admitted to the Rockefeller University Hospital for the 10 week in-patient phase of the study. You begin with 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 50% calorie deficit compared to the weight stabilization period. This will be followed by a 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) and one iron supplement per day. 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 study. Your urine will be tested for pregnancy once during the stabilization and weight maintenance phases of the study.



What specifically makes a person eligible for the study?
You may be eligible to enter this study:

1. Are a man or a woman with a body mass index (BMI) of 30 to 34.9 Calculate_BMI

2. Or a man with a BMI of 25 to 29.9 (Calculate_BMI) with a waist circumference > 102cm (40in)

3. Or a woman with a BMI of 25 to 29.9 (Calculate_BMI) with a waist circumference > 88cm (35in)



Gender:
Both

Age(s):
30 to 50 years

Children permitted to participate:
No

Potential Benefits.....
The benefits you might expect from taking part in this research study are:

You will have a medical history taken, physical examination, and laboratory tests free of charge.

You will be informed about the results of the physical exam and non-experimental laboratory tests done during the study. With your consent, these results will also be available to your health care provider(s) with your consent.

All participants in this study will lose weight. Whether you get the high carbohydrate diet or the high fat/protein weight loss diet will be decided by chance.





Compensation:
There is no cost to you for being in this research study. Upon completion of the inpatient phase, we will give you $15/day to help pay for your costs or time spent being in this research study. If you are unable to complete the study, you will be paid on a prorated basis based on the reimbursement schedule outlined above.

For purposes of reporting to the Internal Revenue Service payments more than $600 per year that are made to me, my social security number is: ____________________

During the research study, you will not receive routine care for your preexisting/ unrelated medical conditions.

If a discovery resulting from this research is commercialized, there are no plans to pay you any money resulting from such activity. However, you do not give up any rights you may have by signing this form