Low Carbohydrate/High Fat Diet in the Treatment of Obesity
This study is currently recruiting patients.
Verified by Rockefeller University March 2006
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
Behavior: Low calorie high fat/protein diet
MedlinePlus related topics: Obesity
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: Exploratory Feasibility Study: High Fat/Protein Diet in the Treatment of Obesity
Further study details as provided by Rockefeller University:
Primary Outcomes: Visceral adipose tissue
Secondary Outcomes: Body composition, fluid and electrolyte balance, lipids/lipoprotein metabolism, markers of inflammation, glucose and insulin metabolism, fat hormones, blood pressure and measures of satiety.
Expected Total Enrollment: 50
Study start: March 2006
Last follow-up: March 2006
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: 30 Years - 50 Years, Genders Eligible for Study: Female
Accepts Healthy Volunteers
Criteria
Inclusion Criteria:
•Body mass index (BMI) of 30 to 34.9 or •BMI of 25 to 29.9 and a waist circumference > 88cm (35in) •Pre-menopausal-
Exclusion Criteria:
•High Blood Pressure •High Cholesterol •Diabetes •Anemia •Liver disease •Kidney disease •HIV positive •Syphilis •Hepatitis B/C positive
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00299273
Lauren Golden, MD 212-327-7445
lgolden@rockefeller.edu
New York
Rockefeller University Hospital, New York, New York, 10021, United States; Recruiting
Lauren Golden, MD 212-327-7445
lgolden@rockefeller.edu
Jan L. Breslow, MD, Principal Investigator
Study chairs or principal investigators
Jan L. Breslow, MD, Principal Investigator, Rockefeller University
More Information
http://www.rucares.org:8001/rucares/admin/form.php?id
Study ID Numbers: RUH IRB # JBR-0583
Last Updated: March 3, 2006
Record first received: March 2, 2006
ClinicalTrials.gov Identifier: NCT00299273
Health Authority: United States: Food and Drug Administration
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