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The Safety and Efficacy of Low and High Carbohydrate Diets

Sponsor
Temple University (Other)
Overall Status
Completed
CT.gov ID
NCT00143936
Collaborator
National Center for Complementary and Integrative Health (NCCIH) (NIH), National Institutes of Health (NIH) (NIH)
360
Enrollment
3
Locations
2
Arms
70.1
Duration (Months)
120
Patients Per Site
1.7
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Low- Carbohydrate -Atkins Diet
  • Behavioral: Low Calorie Diet
 Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
360 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Safety and Efficacy of Low and High Carbohydrate Diets
Study Start Date :
Apr 1, 2003
Actual Primary Completion Date :
Feb 1, 2009
Actual Study Completion Date :
Feb 1, 2009

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • 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 Names:
  • low cal

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Weight loss [2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 University of Colorado Denver Colorado United States
    2 Washington University St. Louis Missouri United States
    3 Temple University Philadelphia Pennsylvania United States 19140

    Sponsors and Collaborators

    • Temple University
    • National Center for Complementary and Integrative Health (NCCIH)
    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00143936
    Other Study ID Numbers:
    • R01AT001103
    • 1R01AT001103-01
    First Posted:
    Sep 2, 2005
    Last Update Posted:
    Jan 15, 2010
    Last Verified:
    Jan 1, 2008
    Keywords provided by , ,
    Weight Loss

    Study Results

    No Results Posted as of Jan 15, 2010