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Comparison of Popular Weight Loss Diets - Article


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Clinical Trial: Comparison of Popular Weight Loss Diets

This study is no longer recruiting patients.

Sponsored by: National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by: National Center for Complementary and Alternative Medicine (NCCAM)

Purpose

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

Condition Treatment or Intervention Phase
Obesity
 Behavior: Atkins diet (extremely low carbohydrate)
 Behavior: Zone diet (low carbohydrate, high protein)
 Behavior: Ornish diet (very low fat)
Phase II

MedlinePlus related topics:  Obesity

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title: Benefits & Risks of Popular Weight Loss Diets

Further Study Details: 

Expected Total Enrollment:  48

Study start: July 2002;  Study completion: June 2004

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 will have 4 study visits 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.

Eligibility

Ages Eligible for Study:  30 Years   -   50 Years,  Genders Eligible for Study:  Female

Accepts Healthy Volunteers

Criteria

Inclusion Criteria

  • Body mass index (BMI) between 27 and 40 kg/m2
  • Weight stable for last 2 months
  • Not actively on a weight loss plan
  • No plans to move from the area over the next 2 years
  • Willing to accept random assignment

Exclusion Criteria

  • Pregnant or breastfeeding
  • Within 6 months of giving birth or planning to become pregnant in the next 2 years
  • Diabetes (type 1 or 2) or history of gestational diabetes
  • Renal or liver disease, active neoplasms, or recent myocardial infarction
  • Hyper- or hypothyroidism
  • Lipid lowering medications or medications known to affect weight/energy expenditure
  • Excessive alcohol intake (self-reported, > 3 drinks/day)
  • Postmenopausal, including surgical menopause
  • Currently under psychiatric care or severely clinically depressed (> 17 on Beck Inventory)

Location Information


California
      Stanford Prevention Research Center, Stanford,  California,  94305,  United States

Study chairs or principal investigators

Christopher D. Gardner, PhD,  Principal Investigator,  Stanford University   

More Information

Stanford Center for Research in Disease Prevention

Study ID Numbers:  1 R21 AT01098-01A1
Record last reviewed:  October 2004
Last Updated:  October 16, 2004
Record first received:  March 9, 2004
ClinicalTrials.gov Identifier:  NCT00079573
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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November 29, 2009



Page Updated: June 20, 2006
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