The Safety and Effectiveness of Low and High Carbohydrate Diets - Tabular View

Tracking Information

First Received Date ^ICMJE

March 9, 2004

Last Updated Date

January 2, 2008

Start Date ^ICMJE

April 2003

Estimated Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

weight change [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00079547 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

change in lipids [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
blood pressure change [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Ketones [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Endothelial Function [ Time Frame: 2 ] [ Designated as safety issue: No ]
change in exercise endurance [ Time Frame: 2 years ] [ Designated as safety issue: No ]
change in renal function [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
change in bone density [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
change in body composition [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

The Safety and Effectiveness of Low and High Carbohydrate Diets

Official Title ^ICMJE

The Safety and Efficacy of Low and High Carbohydrate Diets

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 Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Obesity

Intervention ^ICMJE

Behavioral: Low-calorie diet
Behavioral: low-carbohydrate diet

Study Arms / Comparison Groups

Active Comparator: Low-calorie diet
Experimental: Low-carbohydrate diet

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

307

Estimated Completion Date

March 2008

Estimated Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 appetite, 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
Osteoporosis
Certain types of hormone replacement therapy
Currently following a vegetarian diet

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00079547

Responsible Party

Gary D. Foster, Ph.D., Temple University

Study ID Numbers ^ICMJE

R01 AT001103-01, R01 AT001103-01

Study Sponsor ^ICMJE

National Center for Complementary and Alternative Medicine (NCCAM)

Collaborators ^ICMJE

Office of Dietary Supplements (ODS)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Heart, Lung, and Blood Institute (NHLBI)

Investigators ^ICMJE

Principal Investigator:	Gary D Foster, PhD	University of Pennsylvania
Principal Investigator:	Holly Wyatt, MD	University of Colorado at Denver and Health Sciences Center
Principal Investigator:	James Hill, PhD	University of Colorado at Denver and Health Sciences Center
Principal Investigator:	Samuel Klein, MD	Washington University School of Medicine

Information Provided By

National Center for Complementary and Alternative Medicine (NCCAM)

Verification Date

January 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP