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Home > "T" Clinical Trials Conditions > The Safety and Effectiveness of Low and High Carbohydrate Diets  The Safety and Effectiveness of Low and High Carbohydrate Diets
The Safety and Effectiveness of Low and High Carbohydrate Diets
For Condition: Obesity
Status: Not yet recruiting
Sponsor(s): National Center for Complementary and Alternative Medicine (NCCAM) ,
Synopsis: This study will compare the safety and the effectiveness of a low carbohydrate diet (Atkins diet) with a high carbohydrate diet (conventional USDA diet).
Details: 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; and 3) exercise tolerance. Each participant will be enrolled in the study for 2 years.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - Body mass index between 30 and 40 - Live and work within 1 hour of the study site - Stable psychological status Exclusion criteria - History of heart disease, heart attack, or stroke - Blood pressure >140/90 mmHg - Abnormal cholesterol levels - Significant psychiatric illness - Any medication that affects weight or metabolic rate - Presence or history of a chronic disease that is known to affect appetite, food intake, or metabolism (i.e., diabetes, thyroid disease, or cancer) - Currently using antidepressants, steroids, tobacco, or illegal drugs - Pregnant, breastfeeding, or planning pregnancy - 10 lb change in weight within 6 months of study entry - History of malignant arrhythmias or cerebrovascular, renal, or hepatic disease - History of protein wasting diseases or gout - Severe arthritis - Osteoporosis - Certain types of hormone replacement therapy - Currently following a vegetarian diet
Total Enrollment: 360
Location and Contact Information:
Overall Study Official:
HollyWyatt, Principal Investigator, University of Colorado
University of Colorado
Denver, Colorado,
United States
Carrie Brill
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Brooke Bailer
Washington University
St. Louis, Missouri,
United States
Daniela Hindman
Additional Information:
Study ID Numbers: 1 R01 AT01103-01;
Study Start Date: April 2003
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00079547
Other Obesity Studies:
1. Theory-based Interventions for Smoking and Obesity (Challenge) Trial
2. Effects of Leptin Treatment on Weight Loss
3. Safety and Efficacy of Xenical in Children and Adolescents with Obesity-Related Diseases
4. Influence of diet and endurance running on intramuscular lipids measured at 4.1 TESLA
5. National Growth and Health Study (NGHS)
Related Studies:
Other Obesity Clinical Trials
Other Colorado Clinical Trials
Other Denver Clinical Trials
The Safety and Effectiveness of Low and High Carbohydrate Diets
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