This is a follow-up research study to determine if there are any differences in the long-term maintenance of two diet groups, the Atkins’ diet (low-carbohydrate) or the LEARN program (low-fat). The Atkins’ diet continues to get a significant amount of popular attention and very little scientific evaluation. Due to the small amount of scientific data to support a low-carbohydrate diet and given the wide spread use of this type of diet, it is important to evaluate the long-term safety and effectiveness of the Atkins’ diet.

We will evaluate whether there are any differences between these two groups 3-years after participation in the initial 1-year study period. We will specifically assess weight, cholesterol levels, glucose and insulin levels, and eating habits and mood as we did originally.

Condition	Intervention	Phase
Obesity	Behavior: Low Carbohydrate Diet	Phase IV

Further Study Details: 

Primary Outcomes: Obesity

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

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 appetite, 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 • Osteoporosis • Certain types of hormone replacement therapy • Currently following a vegetarian diet

Please refer to this study by ClinicalTrials.gov identifier  NCT00143962

Diane Rosenbaum       rdiane@mail.med.upenn.edu

Colorado
      University of Colorado, Denver,  Colorado,  United States; Recruiting
Missouri
      Washington University, St. Louis,  Missouri,  United States; No longer recruiting
Pennsylvania
      University of Pennsylvania, Philadelphia,  Pennsylvania,  United States; Recruiting

Study chairs or principal investigators

Gary Foster, PhD,  Principal Investigator,  University of Pennsylvania   
Holly Wyatt, MD,  Principal Investigator,  University of Colorado   
James Hill, PhD,  Principal Investigator,  University of Colorado   
Samuel Klein, MD,  Principal Investigator,  Washington University School of Medicine   

Study ID Numbers:  801787
Last Updated:  September 1, 2005
Record first received:  September 1, 2005
ClinicalTrials.gov Identifier:  NCT00143962
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-06