The Safety and Effectiveness of Low and High Carbohydrate Diets

Phase 4

Completed

• Conditions: Obesity
• Interventions: Behavioral: Low-calorie diet; Behavioral: low-carbohydrate diet

• Registration Number: NCT00079547
• Lead Sponsor: Temple University

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 Timeline

• Study Start: 2003-04
• Study First Submitted: 2004-03-09
• Study First Submitted QC: 2004-03-09
• Study First Posted: 2004-03-10
• Status Verified: 2008-01
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Last Update Submitted: 2013-06-28
• Last Update Posted: 2013-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 307

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Low-calorie diet	Low-calorie diet
2	low-carbohydrate diet	Low-carbohydrate diet

Primary Outcome Measures

Name	Time	Method
weight change	2 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Washington University; 🇺🇸 St. Louis, Missouri, United States

University of Colorado; 🇺🇸 Denver, Colorado, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States