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(JBR-0583) High Fat/High Protein Diet in the Treatment of Obesity


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Exploratory Feasibility Study: High Fat/Protein Diet in the Treatment of Obesity (JBR-0583)

Principal Investigator:
Jan L. Breslow M.D.

Investigators:

Contact Information:
Clinical Research Support Office
Rockefeller University
1230 York Avenue
New York, NY 10021
Telephone: 1800-RU-CARES
Alt. Telephone: 1800-782-2737
Email: rucares@rockefeller.edu
Enrollment Status:
Closed to Enrollment

Brief Summary of Protocol:
The purpose of this study is to examine the effects of a low calorie, low carbohydrate-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.



Detailed Description of Protocol:
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, low-carbohydrate-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.





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

Body mass index (BMI) of 30 to 34.9 (calculate BMI) or

BMI of 25 to 29.9 (calculate BMI) and a waist circumference > 88cm (35in)

Pre-menopausal

Calculate_BMI

Gender:
Female

Age(s):
25-50

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, although individual weight loss may vary.





Compensation:
There is no cost to you for being in this research study. Upon completion of the inpatient phase, we will give you $25/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.

Payments of more than $600 per year are reported to the Internal Revenue Service.

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