The Safety and Efficacy of Low and High Carbohydrate Diets
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Temple University
- Enrollment
- 307
- Locations
- 6
- Primary Endpoint
- weight change
Study Overview
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
weight change
Time Frame: 2 years
Secondary Outcomes
- change in lipids(2 years)
- blood pressure change(2 years)
- Ketones(2 years)
- Endothelial Function(2)
- change in exercise endurance(2 years)
- change in renal function(2 years)
- change in bone density(2 years)
- change in body composition(2 years)