Low Carbohydrate/High Fat Diet in the Treatment of Obesity Clinical Trial

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

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

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.

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

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

Study chairs or principal investigators

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

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

 

 

Weight Control (National Library of Medicine)

Low-Carbohydrate Diets Appear Effective, but May Raise Cholesterol Levels  (American Medical Association)

Low Carb Diets and Your Lab Tests  (American Association for Clinical Chemistry)

Weight-Loss and Nutrition Myths: How Much Do You Really Know?  (National Institute of Diabetes and Digestive and Kidney Diseases)

ClinicalTrials.gov: Diet, Reducing  (National Institutes of Health)

Energy Density and Weight Loss: Feel Full on Fewer Calories  (Mayo Foundation for Medical Education and Research)

Fad Diets: What You Need to Know  (American Academy of Family Physicians)

Healthy Weight  (Harvard School of Public Health)

Fit and Fabulous As You Mature  (National Institute of Diabetes and Digestive and Kidney Diseases)

ClinicalTrials.gov: Weight Loss  (National Institutes of Health)

Weight-Loss Help: How to Stop Emotional Eating  (Mayo Foundation for Medical Education and Research)

Eating Healthy Starts with Healthy Food Shopping  (National Heart, Lung, and Blood Institute)