High Fat - High Protein Diet in the Treatment of Obesity
Primary Purpose
Obesity
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low calorie high fat/protein diet
Sponsored by

About this trial
This is an interventional treatment trial for Obesity focused on measuring Obesity;, Low calorie high fat/protein diet;, Low-carbohydrate diet, Weight Loss
Eligibility 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
Sites / Locations
- The Rockefeller University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Low calorie high fat/protein diet
Arm Description
Low calorie high fat/protein diet
Outcomes
Primary Outcome Measures
Visceral adipose tissue
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.
Full Information
NCT ID
NCT00299273
First Posted
March 2, 2006
Last Updated
June 4, 2015
Sponsor
Rockefeller University
Collaborators
St. Luke's-Roosevelt Hospital Center
1. Study Identification
Unique Protocol Identification Number
NCT00299273
Brief Title
High Fat - High Protein Diet in the Treatment of Obesity
Official Title
Exploratory Feasibility Study: High Fat/Protein Diet in the Treatment of Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Terminated
Why Stopped
PI left institution
Study Start Date
March 2006 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rockefeller University
Collaborators
St. Luke's-Roosevelt Hospital Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity;, Low calorie high fat/protein diet;, Low-carbohydrate diet, Weight Loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low calorie high fat/protein diet
Arm Type
Experimental
Arm Description
Low calorie high fat/protein diet
Intervention Type
Behavioral
Intervention Name(s)
Low calorie high fat/protein diet
Intervention Description
6 weeks of caloric restriction (50%) on a high fat/protein diet
Primary Outcome Measure Information:
Title
Visceral adipose tissue
Time Frame
after 6 weeks
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan L. Breslow, MD
Organizational Affiliation
The Rockefeller University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Rockefeller University Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
12. IPD Sharing Statement
Learn more about this trial
High Fat - High Protein Diet in the Treatment of Obesity
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