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The Safety and Efficacy of Low and High Carbohydrate Diets

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ClinicalTrials.gov Identifier: NCT00143936
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : January 15, 2010
National Center for Complementary and Integrative Health (NCCIH)
National Institutes of Health (NIH)
Information provided by:
Temple University

September 1, 2005
September 2, 2005
January 15, 2010
April 2003
February 2009   (Final data collection date for primary outcome measure)
Weight loss [ Time Frame: 2 years ]
Not Provided
Complete list of historical versions of study NCT00143936 on ClinicalTrials.gov Archive Site
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The Safety and Efficacy of Low and High Carbohydrate Diets
The Safety and Efficacy of Low and High Carbohydrate Diets
This study will compare the safety and effectiveness of a low carbohydrate diet (Atkins Diet) with a high carbohydrate diet (conventional USDA diet).

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.

Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Behavioral: Low- Carbohydrate -Atkins Diet
    Low Carbohydrate Diet
    Other Name: low carb
  • Behavioral: Low Calorie Diet
    Maintain a low calorie diet
    Other Name: low cal
  • Active Comparator: Low Carb
    Low Cabohydrate Diet: 20 week of weekly group behavior modification, 20 weekly bi-weekly, bi-monthly to finish
    Intervention: Behavioral: Low- Carbohydrate -Atkins Diet
  • Active Comparator: Low Calorie
    Low Calorie Diet: 20 weeks of weekly behavior modification, 20 weekly of bi-weekly, bimonthly to finish 2 years
    Intervention: Behavioral: Low Calorie Diet

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
February 2009
February 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
R01AT001103( U.S. NIH Grant/Contract )
1R01AT001103-01 ( U.S. NIH Grant/Contract )
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Not Provided
Gary D. Foster, PhD, Temple University
Temple University
  • National Center for Complementary and Integrative Health (NCCIH)
  • National Institutes of Health (NIH)
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
Temple University
January 2008

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