Clinical Trials Directory

Trials / Completed

CompletedNCT00079573

Comparison of Popular Weight Loss Diets

Benefits & Risks of Popular Weight Loss Diets

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
300 (planned)
Sponsor
National Center for Complementary and Integrative Health (NCCIH) · NIH
Sex
Female
Age
30 Years – 50 Years
Healthy volunteers
Accepted

Summary

This study will compare the safety and effectiveness of three popular weight loss plans. These plans will be compared with the USDA Dietary Guidelines.

Detailed description

Obesity is the single most significant, nutrition-related health issue of the new millennium. Several "medical experts" have designed and promoted weight loss diets that dramatically differ from one another and from the USDA Dietary Guidelines. These diets have gained surprisingly widespread and persistent popularity among Americans despite the lack of evidence supporting their claims. This clinical trial will provide preliminary feasibility data for a full-scale study that will examine health outcomes (e.g., benefits, risks, success) of three popular weight loss diets. The study will investigate behavioral and physiological factors that influence adherence and retention to these diet plans. Overweight women will be randomly assigned to one of four diets for 1 year: Atkins (extremely low carbohydrate), Zone (low carbohydrate, high protein), Ornish (very low fat), or USDA/Food Pyramid (high carbohydrate/moderate-low fat). Behavioral and physiological data will be collected. Participants attend study visits at baseline, 8 weeks, 6 months, and 1 year. At these visits, measurements will include that will include weight and blood pressure measurements and blood tests. Participants will be asked to complete ten questionnaires over the course of the study to assess behavior and appetite. Participants will also undergo a DEXA scan to assess body composition.

Conditions

Interventions

TypeNameDescription
BEHAVIORALAtkins diet (extremely low carbohydrate)
BEHAVIORALZone diet (low carbohydrate, high protein)
BEHAVIORALOrnish diet (very low fat)

Timeline

Start date
2002-07-01
Completion
2004-06-01
First posted
2004-03-10
Last updated
2006-08-18

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00079573. Inclusion in this directory is not an endorsement.