The Safety and Effectiveness of Low and High Carbohydrate Diets

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2008 by Temple University. Recruitment status was Active, not recruiting

First Received on March 9, 2004. Last Updated on September 27, 2010 History of Changes

Sponsor:	Temple University
Collaborators:	National Center for Complementary and Alternative Medicine (NCCAM) Office of Dietary Supplements (ODS) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	Temple University
ClinicalTrials.gov Identifier:	NCT00079547

Purpose

This study will compare the safety and the effectiveness of a low carbohydrate diet (Atkins diet) with a high carbohydrate diet (conventional USDA diet).

Condition	Intervention	Phase
Obesity	Behavioral: Low-calorie diet Behavioral: low-carbohydrate diet	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	The Safety and Efficacy of Low and High Carbohydrate Diets

Resource links provided by NLM:

MedlinePlus related topics: Obesity

U.S. FDA Resources

Further study details as provided by Temple University:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Enrollment:	307
Study Start Date:	April 2003
Estimated Study Completion Date:	March 2008
Estimated Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Low-calorie diet	Behavioral: Low-calorie diet low-calorie diet
Experimental: 2 Low-carbohydrate diet	Behavioral: low-carbohydrate diet low-carbohydrate 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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00079547

Locations

United States, Colorado
University of Colorado
Denver, Colorado, United States, 80262
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

Temple University

National Center for Complementary and Alternative Medicine (NCCAM)

Office of Dietary Supplements (ODS)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

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

More Information

No publications provided by Temple University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

de las Fuentes L, Waggoner AD, Mohammed BS, Stein RI, Miller BV 3rd, Foster GD, Wyatt HR, Klein S, Davila-Roman VG. Effect of moderate diet-induced weight loss and weight regain on cardiovascular structure and function. J Am Coll Cardiol. 2009 Dec 15;54(25):2376-81.

Responsible Party:	Gary D. Foster, Ph.D., Temple University
ClinicalTrials.gov Identifier:	NCT00079547 History of Changes
Other Study ID Numbers:	R01 AT001103-01, R01AT001103-01, R01 AT001103-01
Study First Received:	March 9, 2004
Last Updated:	September 27, 2010
Health Authority:	United States: Federal Government

Keywords provided by Temple University:

Weight Loss

Additional relevant MeSH terms:

Obesity
Overnutrition
Nutrition Disorders

Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on February 09, 2012