The Safety and Efficacy of Low and High Carbohydrate Diets - Full Text View

Sponsor:	Temple University
Collaborators:	National Center for Complementary and Alternative Medicine (NCCAM) National Institutes of Health (NIH)
Information provided by:	Temple University
ClinicalTrials.gov Identifier:	NCT00143936

Purpose

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

Condition	Intervention	Phase
Obesity	Behavioral: Low- Carbohydrate -Atkins Diet Behavioral: Low Calorie 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 Weight Control

U.S. FDA Resources

Further study details as provided by Temple University:

Primary Outcome Measures:

Weight loss [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment:	360
Study Start Date:	April 2003
Study Completion Date:	February 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Low Carb Low Cabohydrate Diet: 20 week of weekly group behavior modification, 20 weekly bi-weekly, bi-monthly to finish	Behavioral: Low- Carbohydrate -Atkins Diet Low Carbohydrate Diet Other Name: low carb
Active Comparator: Low Calorie Low Calorie Diet: 20 weeks of weekly behavior modification, 20 weekly of bi-weekly, bimonthly to finish 2 years	Behavioral: Low Calorie Diet Maintain a low calorie diet Other Name: low cal

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.

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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00143936

Locations

United States, Colorado
University of Colorado
Denver, Colorado, United States
United States, Missouri
Washington University
St. Louis, Missouri, United States
United States, Pennsylvania
Temple University
Philadelphia, Pennsylvania, United States, 19140

Sponsors and Collaborators

Temple University

National Center for Complementary and Alternative Medicine (NCCAM)

National Institutes of Health (NIH)

Investigators

Principal Investigator:	Gary 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):

Foster GD, Wyatt HR, Hill JO, Makris AP, Rosenbaum DL, Brill C, Stein RI, Mohammed BS, Miller B, Rader DJ, Zemel B, Wadden TA, Tenhave T, Newcomb CW, Klein S. Weight and metabolic outcomes after 2 years on a low-carbohydrate versus low-fat diet: a randomized trial. Ann Intern Med. 2010 Aug 3;153(3):147-57.

Responsible Party:	Gary D. Foster, PhD, Temple University
ClinicalTrials.gov Identifier:	NCT00143936 History of Changes
Other Study ID Numbers:	R01 AT 001103, 1 R01 AT01103-01
Study First Received:	September 1, 2005
Last Updated:	January 14, 2010
Health Authority:	United States: Institutional Review Board

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