Expired Study
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Philadelphia, Pennsylvania 19140


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

Study summary:

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.


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 is Available At:

Original ID:

R01 AT 001103



Secondary ID:

1 R01 AT01103-01

Study Acronym:

Brief Title:

The Safety and Efficacy of Low and High Carbohydrate Diets

Official Title:

The Safety and Efficacy of Low and High Carbohydrate Diets

Overall Status:


Study Phase:

Phase 4



Minimum Age:

18 Years

Maximum Age:

65 Years

Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Temple University

Oversight Authority:

United States: Institutional Review Board

Reasons Why Stopped:

Study Type:


Study Design:

Allocation: Randomized, Endpoint Classification:

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:


Overall Contact Information

Official Name:Gary Foster, PhD
Principal Investigator
University of Pennsylvania

Study Dates

Start Date:April 2003
Completion Date:February 2009
Completion Type:Actual
Primary Completion Date:February 2009
Primary Completion Type:Actual
Verification Date:January 2008
Last Changed Date:January 14, 2010
First Received Date:September 1, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure:Weight loss
Time Frame:2 years
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Low- Carbohydrate -Atkins Diet
Description:Low Carbohydrate Diet
Arm Name:Low Carb
Other Name:low carb
Intervention Type:Behavioral
Name:Low Calorie Diet
Description:Maintain a low calorie diet
Arm Name:Low Calorie
Other Name:low cal

Study Arms

Study Arm Type:Active Comparator
Arm Name:Low Carb
Description:Low Cabohydrate Diet: 20 week of weekly group behavior modification, 20 weekly bi-weekly, bi-monthly to finish
Study Arm Type:Active Comparator
Arm Name:Low Calorie
Description:Low Calorie Diet: 20 weeks of weekly behavior modification, 20 weekly of bi-weekly, bimonthly to finish 2 years

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Temple University
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Center for Complementary and Alternative Medicine (NCCAM)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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