High Fat - High Protein Diet in the Treatment of Obesity

This study has been terminated.
(PI left institution)
St. Luke's-Roosevelt Hospital Center
Information provided by (Responsible Party):
Rockefeller University
ClinicalTrials.gov Identifier:
First received: March 2, 2006
Last updated: June 4, 2015
Last verified: June 2015
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
Behavioral: Low calorie high fat/protein diet

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Exploratory Feasibility Study: High Fat/Protein Diet in the Treatment of Obesity

Further study details as provided by Rockefeller University:

Primary Outcome Measures:
  • Visceral adipose tissue [ Time Frame: after 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Body composition, fluid and electrolyte balance, lipids/lipoprotein metabolism, markers of inflammation, glucose and insulin metabolism, fat hormones, blood pressure and measures of satiety. [ Time Frame: after 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: March 2006
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low calorie high fat/protein diet
Low calorie high fat/protein diet
Behavioral: Low calorie high fat/protein diet
6 weeks of caloric restriction (50%) on a high fat/protein diet

Detailed Description:

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:   25 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00299273

United States, New York
The Rockefeller University Hospital
New York, New York, United States, 10021
Sponsors and Collaborators
Rockefeller University
St. Luke's-Roosevelt Hospital Center
Principal Investigator: Jan L. Breslow, MD The Rockefeller University Hospital
  More Information

No publications provided

Responsible Party: Rockefeller University
ClinicalTrials.gov Identifier: NCT00299273     History of Changes
Obsolete Identifiers: NCT00503373
Other Study ID Numbers: JBR-0583
Study First Received: March 2, 2006
Last Updated: June 4, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Rockefeller University:
Low calorie high fat/protein diet;
Low-carbohydrate diet
Weight Loss

Additional relevant MeSH terms:
Body Weight
Nutrition Disorders
Signs and Symptoms

ClinicalTrials.gov processed this record on November 27, 2015