High Carbohydrate vs. High Fat Diets in the Treatment of Obesity (JBR 0512)

January 10, 2012 updated by: Rockefeller University
The purpose of this study is to compare the ability of low calorie high carbohydrate and low calorie high fat/protein diets to decrease abdominal fat in overweight and obese subjects. The investigators will also test the effects of these diets on secondary outcomes including body composition, fluid and electrolyte balance, lipids and lipoproteins, blood pressure, arterial compliance, glucose and insulin metabolism, bone turnover, and measures of satiety.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 consume an average American diet. This is followed by the 6 week weight loss period where subjects will be randomized to either a low calorie high carbohydrate or a low calorie high fat/protein diet. On both diets there will be a 50% calorie deficit 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 will be encouraged to maintain one's 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 the stabilization and weight maintenance phases of the study.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Rockefeller University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Man or a woman with a body mass index (BMI) of 30 to 34.9
  • Man with a BMI of 25 to 29.9 with a waist circumference > 102cm (40in)
  • Woman with a BMI of 25 to 29.9 with a waist circumference > 88cm (35in)

Exclusion Criteria:

  • High Blood Pressure
  • High Cholesterol
  • Diabetes
  • HIV positive
  • Syphilis
  • Hepatitis B/C positive

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: High Fat/Protein Diet
Behavioral: Low calorie high fat/protein diet
High Fat/Protein Diet: 10% carbohydrate, 25% protein, 65% fat (26% SFA, 25% MFA, 9% PUFA), P/S 0.33, 458 mg cholesterol/1500 kcal
Active Comparator: High Carbohydrate Diet
Behavioral: Low calorie high carbohydrate diet
65% carbohydrate, 15% protein, 20% fat (7% SFA, 8% MFA, 4% PUFA), P/S 0.63, 152 mg cholesterol/1500 kcal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Visceral adipose tissue
Time Frame: days 12, 68
days 12, 68

Secondary Outcome Measures

Outcome Measure
Time Frame
Body composition
Time Frame: days 12, 68
days 12, 68
Blood pressure
Time Frame: days 11 and 67
days 11 and 67
Insulin glucose metabolism
Time Frame: days 13, 15 69, 71
days 13, 15 69, 71
Bone turnover
Time Frame: days 14, 70
days 14, 70
Measures of satiety
Time Frame: once a week
once a week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rockefeller University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

July 19, 2005

First Submitted That Met QC Criteria

July 21, 2005

First Posted (Estimate)

July 22, 2005

Study Record Updates

Last Update Posted (Estimate)

January 11, 2012

Last Update Submitted That Met QC Criteria

January 10, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JBR-0512

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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