NCT00079547

The Safety and Effectiveness of Low and High Carbohydrate Diets

The Safety and Efficacy of Low and High Carbohydrate Diets

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 307 (actual)
• Sponsor: Temple University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Obesity

Interventions

Type	Name	Description
BEHAVIORAL	Low-calorie diet	low-calorie diet
BEHAVIORAL	low-carbohydrate diet	low-carbohydrate diet

Timeline

• Start date: 2003-04-01
• Primary completion: 2008-03-01
• Completion: 2008-03-01
• First posted: 2004-03-10
• Last updated: 2013-07-01

Locations

3 sites across 1 country: United States