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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rockefeller University
ClinicalTrials.gov Identifier:
NCT00123240
First received: July 19, 2005
Last updated: January 10, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention
Obesity
 Behavioral: Low calorie high carbohydrate diet
Behavioral: Low calorie high fat/protein diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: High Carbohydrate vs. High Fat Diets in the Treatment of Obesity (JBR 0512)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rockefeller University:

Primary Outcome Measures:
  • Visceral adipose tissue [ Time Frame: days 12, 68 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Body composition [ Time Frame: days 12, 68 ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: days 11 and 67 ] [ Designated as safety issue: No ]
  • Insulin glucose metabolism [ Time Frame: days 13, 15 69, 71 ] [ Designated as safety issue: No ]
  • Bone turnover [ Time Frame: days 14, 70 ] [ Designated as safety issue: No ]
  • Measures of satiety [ Time Frame: once a week ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: July 2004
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   30 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00123240

Locations
United States, New York
Rockefeller University
New York, New York, United States, 10021
Sponsors and Collaborators
Rockefeller University
Investigators
Principal Investigator: Jan L. Breslow, MD Rockefeller University
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Rockefeller University
ClinicalTrials.gov Identifier: NCT00123240     History of Changes
Other Study ID Numbers: JBR-0512
Study First Received: July 19, 2005
Last Updated: January 10, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Rockefeller University:
overweight
obese
diet

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

ClinicalTrials.gov processed this record on May 22, 2013