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Sponsors and Collaborators: |
Temple University National Center for Complementary and Alternative Medicine (NCCAM) National Institutes of Health (NIH) |
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Information provided by: | Temple University |
ClinicalTrials.gov Identifier: | NCT00143936 |
This study will compare the safety and effectiveness of a low carbohydrate diet (Atkins Diet) with a high carbohydrate diet (conventional USDA diet).
Condition | Intervention | Phase |
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Obesity |
Behavioral: Atkins Diet Behavioral: Low Calorie Diet |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | The Safety and Efficacy of Low and High Carbohydrate Diets |
Enrollment: | 360 |
Study Start Date: | April 2003 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Low Cabohydrate Diet
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Behavioral: Atkins Diet
Low Carbohydrate Diet
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2: Active Comparator
Low Calorie Diet
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Behavioral: Low Calorie Diet
Maintain a low calorie diet
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Despite the considerable mass appeal of popular diet books, such diet approaches lack data to support their efficacy and safety. Despite its widespread use for more than 30 years, the Atkins diet has never been evaluated in a large, randomized, controlled trial. This study will assess the short-term and long-term clinical effects of a low-carbohydrate diet and a high-carbohydrate diet in overweight and obese men and women.
Participants in this study will be randomly assigned to the Atkins diet (low-carbohydrate, unlimited fat and protein) or a conventional USDA diet (high-carbohydrate, low fat). The study will evaluate the effects of each dietary approach on changes in: 1) weight and body composition, 2) metabolic and organ function, 3) exercise tolerance. Each participant will be enrolled in the study for 2 years.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Colorado | |
University of Colorado | |
Denver, Colorado, United States | |
United States, Missouri | |
Washington University | |
St. Louis, Missouri, United States | |
United States, Pennsylvania | |
Temple University | |
Philadelphia, Pennsylvania, United States, 19140 |
Principal Investigator: | Gary Foster, PhD | University of Pennsylvania |
Principal Investigator: | Holly Wyatt, MD | University of Colorado at Denver and Health Sciences Center |
Principal Investigator: | James Hill, PhD | University of Colorado at Denver and Health Sciences Center |
Principal Investigator: | Samuel Klein, MD | Washington University School of Medicine |
Responsible Party: | Temple University ( Gary D. Foster, PhD ) |
Study ID Numbers: | 707315, 1 R01 AT01103-01 |
Study First Received: | September 1, 2005 |
Last Updated: | January 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00143936 |
Health Authority: | United States: Institutional Review Board |
Weight Loss |
Body Weight Signs and Symptoms Obesity Weight Loss |
Benzocaine Nutrition Disorders Overweight Overnutrition |