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The Safety and Efficacy of Low and High Carbohydrate Diets

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00143936
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : January 15, 2010
Sponsor:
Collaborators:
National Center for Complementary and Integrative Health (NCCIH)
National Institutes of Health (NIH)
Information provided by:
Temple University

Tracking Information
First Submitted Date  ICMJE September 1, 2005
First Posted Date  ICMJE September 2, 2005
Last Update Posted Date January 15, 2010
Study Start Date  ICMJE April 2003
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2008)
Weight loss [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Safety and Efficacy 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 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 1, 2005)
360
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2009
Actual Primary Completion Date February 2009   (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 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00143936
Other Study ID Numbers  ICMJE R01AT001103( U.S. NIH Grant/Contract )
1R01AT001103-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gary D. Foster, PhD, Temple University
Study Sponsor  ICMJE Temple University
Collaborators  ICMJE
  • National Center for Complementary and Integrative Health (NCCIH)
  • National Institutes of Health (NIH)
Investigators  ICMJE
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
PRS Account Temple University
Verification Date January 2008

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