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High Fat - High Protein Diet in the Treatment of Obesity

This study has been terminated.
(PI left institution)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00299273
First Posted: March 6, 2006
Last Update Posted: June 8, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
St. Luke's-Roosevelt Hospital Center
Information provided by (Responsible Party):
Rockefeller University
  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 Behavioral: Low calorie high fat/protein diet

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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 ]

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 ]

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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   25 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00299273


Locations
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
Investigators
Principal Investigator: Jan L. Breslow, MD The Rockefeller University Hospital
  More Information

Responsible Party: Rockefeller University
ClinicalTrials.gov Identifier: NCT00299273     History of Changes
Obsolete Identifiers: NCT00503373
Other Study ID Numbers: JBR-0583
First Submitted: March 2, 2006
First Posted: March 6, 2006
Last Update Posted: June 8, 2015
Last Verified: June 2015

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

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