The Safety and Efficacy of Low and High Carbohydrate Diets

January 14, 2010 updated by: Temple University
This study will compare the safety and effectiveness of a low carbohydrate diet (Atkins Diet) with a high carbohydrate diet (conventional USDA diet).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

360

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight loss
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Temple University

Collaborators

National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: James Hill, PhD, University of Colorado, Denver
  • Principal Investigator: Gary Foster, PhD, University of Pennsylvania
  • Principal Investigator: Holly Wyatt, MD, University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

September 1, 2005

First Submitted That Met QC Criteria

September 1, 2005

First Posted (Estimate)

September 2, 2005

Study Record Updates

Last Update Posted (Estimate)

January 15, 2010

Last Update Submitted That Met QC Criteria

January 14, 2010

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • R01AT001103 (U.S. NIH Grant/Contract)
  • 1R01AT001103-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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