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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00123240
First Posted: July 22, 2005
Last Update Posted: January 11, 2012
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.
Information provided by (Responsible Party):
Rockefeller University
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High Carbohydrate vs. High Fat Diets in the Treatment of Obesity (JBR 0512)

Further study details as provided by Rockefeller University:

Primary Outcome Measures:
  • Visceral adipose tissue [ Time Frame: days 12, 68 ]

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

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

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:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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
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): 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:
Responsible Party: Rockefeller University
ClinicalTrials.gov Identifier: NCT00123240     History of Changes
Other Study ID Numbers: JBR-0512
First Submitted: July 19, 2005
First Posted: July 22, 2005
Last Update Posted: January 11, 2012
Last Verified: January 2012

Keywords provided by Rockefeller University:
overweight
obese
diet

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