NCT00006193

Brief Summary

Dr. Atkins' New Diet Revolution has sold over 10 million copies and has been on the New York Times best seller list for 158 weeks. This and other low-carbohydrate diets, such as the ZONE, Sugar Busters, and the Carbohydrate Addicts Diet, have attracted much popular attention but little scientific evaluation. Given the widespread use of these diets, it seems prudent to evaluate them both for safety and efficacy. Therefore, the purpose of the study is to compare the effectiveness of two different weight control programs over the course of 52 weeks. These two programs are 1) the Atkins' New Diet Revolution, a low-carbohydrate, high-protein diet, and 2) Brownell's LEARN Program, a high carbohydrate, low fat diet based on behavior modification. Specifically, this study will compare short-term changes in weight, food intake, blood chemistries and mood in adult males (n=10) and females (n=10) who are randomized to either the Atkins' Diet or the LEARN Program for a period of one year. During this year, they will be under medical supervision. We will examine the effect of the two weight loss plans on changes in lipids, blood pressure, insulin sensitivity and ketones, and eating behavior. This is a feasibility study and thus the data will ultimately be used to design a large randomized trial with adequate statistical power.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 8, 2000

Completed
Last Updated

June 24, 2005

Status Verified

November 1, 2001

First QC Date

September 7, 2000

Last Update Submit

June 23, 2005

Conditions

Interventions

dietBEHAVIORAL

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
\- BMI 25-40 kg/m2 inclusive

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Washington University

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Diet

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

September 7, 2000

First Posted

September 8, 2000

Last Updated

June 24, 2005

Record last verified: 2001-11

Locations