The Safety and Efficacy of Low and High Carbohydrate Diets

Phase 4

Completed

• Conditions: Obesity
• Interventions: Behavioral: Low- Carbohydrate -Atkins Diet; Behavioral: Low Calorie Diet

• Registration Number: NCT00143936
• Lead Sponsor: Temple University

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 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, 3) exercise tolerance. Each participant will be enrolled in the study for 2 years.

Study Timeline

• Study Start: 2003-04
• Study First Submitted: 2005-09-01
• Study First Submitted QC: 2005-09-01
• Study First Posted: 2005-09-02
• Status Verified: 2008-01
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Last Update Submitted: 2010-01-14
• Last Update Posted: 2010-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

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 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Carb	Low- Carbohydrate -Atkins Diet	Low Cabohydrate Diet: 20 week of weekly group behavior modification, 20 weekly bi-weekly, bi-monthly to finish
Low Calorie	Low Calorie Diet	Low Calorie Diet: 20 weeks of weekly behavior modification, 20 weekly of bi-weekly, bimonthly to finish 2 years

Primary Outcome Measures

Name	Time	Method
Weight loss	2 years

Trial Locations

Locations (3)

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

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

Temple University; 🇺🇸 Philadelphia, Pennsylvania, United States