High Carbohydrate vs. High Fat Diets in the Treatment of Obesity (JBR 0512)
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|ClinicalTrials.gov Identifier: NCT00123240|
Recruitment Status : Completed
First Posted : July 22, 2005
Last Update Posted : January 11, 2012
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Behavioral: Low calorie high carbohydrate diet Behavioral: Low calorie high fat/protein diet||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||High Carbohydrate vs. High Fat Diets in the Treatment of Obesity (JBR 0512)|
|Study Start Date :||July 2004|
|Actual Primary Completion Date :||April 2010|
|Actual Study Completion Date :||April 2010|
|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
- Visceral adipose tissue [ Time Frame: days 12, 68 ]
- 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 ]
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
|United States, New York|
|New York, New York, United States, 10021|
|Principal Investigator:||Jan L. Breslow, MD||Rockefeller University|