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Comparison of Popular Weight Loss Diets

This study has been completed.
Sponsor:
Collaborator:
Community Foundation of Southeastern Michigan
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00079573
First received: March 9, 2004
Last updated: August 16, 2006
Last verified: August 2006
History of Changes
  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 Intervention Phase
Obesity
 Behavioral: Atkins diet (extremely low carbohydrate)
Behavioral: Zone diet (low carbohydrate, high protein)
Behavioral: Ornish diet (very low fat)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Benefits & Risks of Popular Weight Loss Diets

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:
  • Weight; measured at each study visit
  • Percent body fat; measured at each study visit

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 300
Study Start Date: July 2002
Estimated Study Completion Date: June 2004
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.

  Eligibility

Ages Eligible for Study:   30 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00079573

Locations
United States, California
Stanford Prevention Research Center
Stanford, California, United States, 94305
Sponsors and Collaborators
National Center for Complementary and Alternative Medicine (NCCAM)
Community Foundation of Southeastern Michigan
Investigators
Principal Investigator: Christopher D. Gardner, PhD Stanford University
  More Information

Additional Information:
Stanford Center for Research in Disease Prevention  This link exits the ClinicalTrials.gov site

No publications provided by National Center for Complementary and Alternative Medicine (NCCAM)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00079573     History of Changes
Other Study ID Numbers: R21 AT001098-01A1
Study First Received: March 9, 2004
Last Updated: August 16, 2006
Health Authority: United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
Weight Loss
Obesity
Overweight
Premenopausal women
Diet

Additional relevant MeSH terms:
Obesity
Weight Loss
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on May 21, 2013