Condition(s) treated: Obesity

Intervention: Low Carbohydrate Diet (Behavior)

Phase: Phase 4

Enrollment status: Recruiting

Sponsor: University of Pennsylvania

Principal investigator(s) or official(s):
Gary Foster, PhD, Principal Investigator, Affiliation: University of Pennsylvania
Holly Wyatt, MD, Principal Investigator, Affiliation: University of Colorado
James Hill, PhD, Principal Investigator, Affiliation: University of Colorado
Samuel Klein, MD, Principal Investigator, Affiliation: Washington University School of Medicine

Overall contact:
Diane Rosenbaum, Email: rdiane@mail.med.upenn.edu

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.

Official title: Comparison of Two Approaches to Weight Loss Follow-Up Study

Study design: Interventional, Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Obesity

Detailed description: ***PLEASE NOTE: Only those who participated in the original study of low carbohydrate and low fat diets are eligable for enrollment in this follow-up study***

Minimum eligible age: 18 Years. Maximum eligible age: 65 Years. Eligible gender(s): Both.

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

Diane Rosenbaum, Email: rdiane@mail.med.upenn.edu

University of Colorado, Denver, Colorado, United States; Recruiting
Carrie Brill, Email: carrie.brill@uchsc.edu

Washington University, St. Louis, Missouri, United States; No longer recruiting

University of Pennsylvania, Philadelphia, Pennsylvania, United States; Recruiting
Diane Rosenbaum, Email: rdiane@mail.med.upenn.edu

Related publications:

Foster GD, Wyatt HR, Hill JO, McGuckin BG, Brill C, Mohammed BS, Szapary PO, Rader DJ, Edman JS, Klein S. A randomized trial of a low-carbohydrate diet for obesity. N Engl J Med. 2003 May 22;348(21):2082-90.

Last updated: December 16, 2005