Status:
COMPLETED
The Safety and Efficacy of Low and High Carbohydrate Diets
Lead Sponsor:
Temple University
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
National Institutes of Health (NIH)
Conditions:
Obesity
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
This study will compare the safety and 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
- Body mass index between 30 and 40
- Live and work within 1 hour of the study site
- Stable psychological status
Exclusion
- 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 appettite, 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
- Osteoperosis
- Certain types of hormone replacement therapy
- Currently following a vegetarian diet
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT00143936
Start Date
April 1 2003
End Date
February 1 2009
Last Update
January 15 2010
Active Locations (3)
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1
University of Colorado
Denver, Colorado, United States
2
Washington University
St Louis, Missouri, United States
3
Temple University
Philadelphia, Pennsylvania, United States, 19140