This study will compare the safety and the effectiveness of a low carbohydrate diet (Atkins diet) with a high carbohydrate diet (conventional USDA diet).

Condition	Treatment or Intervention	Phase
Obesity	Behavior: Atkins diet  Behavior: conventional USDA diet	Phase IV

Further Study Details: 

Expected Total Enrollment:  360

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.

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

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

Brooke Bailer, MS       bbailer@mail.med.upenn.edu

Colorado
      University of Colorado, Denver,  Colorado,  United States
Missouri
      Washington University, St. Louis,  Missouri,  United States
Pennsylvania
      University of Pennsylvania, Philadelphia,  Pennsylvania,  19104,  United States

Study chairs or principal investigators

Gary D Foster, PhD,  Principal Investigator,  University of Pennsylvania   
Holly Wyatt, MD,  Principal Investigator,  University of Colorado   
James Hill, PhD,  Principal Investigator,  University of Colorado   
Samuel Klein, MD,  Principal Investigator,  Washington University School of Medicine   

Study ID Numbers:  1 R01 AT01103-01
Record last reviewed:  January 2005
Last Updated:  January 19, 2005
Record first received:  March 9, 2004
ClinicalTrials.gov Identifier:  NCT00079547
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08