Status:
COMPLETED
The Safety and Effectiveness of Low and High Carbohydrate Diets
Lead Sponsor:
Temple University
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Office of Dietary Supplements (ODS)
Conditions:
Obesity
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
This study will compare the safety and the effectiveness of a low carbohydrate diet (Atkins diet) with a high carbohydrate diet (conventional USDA diet).
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
307 Patients enrolled
Trial Details
Trial ID
NCT00079547
Start Date
April 1 2003
End Date
March 1 2008
Last Update
July 1 2013
Active Locations (3)
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1
University of Colorado
Denver, Colorado, United States, 80262
2
Washington University
St Louis, Missouri, United States, 63110
3
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104