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Clinical Trials/NCT00079573
NCT00079573CompletedPhase 2

Benefits & Risks of Popular Weight Loss Diets

National Center for Complementary and Integrative Health (NCCIH)2 sites in 1 country300 target enrollmentStarted: July 2002Last updated:
Conditions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
300
Locations
2
Primary Endpoint
Weight; measured at each study visit

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single

Eligibility Criteria

Ages
30 Years to 50 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Weight; measured at each study visit

Percent body fat; measured at each study visit

Secondary Outcomes

  • Blood lipids (cholesterol, triglycerides); measured at each study visit
  • Fasting insulin and glucose; measured at each study visit
  • Behavioral variables; measured at each study visit

Investigators

Study Sites (2)

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