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Completed

NCT Number: NCT00079573

Comparison of Popular Weight Loss Diets

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

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Key information

Age range

30 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Stanford Prevention Research Center

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Atkins diet (extremely low carbohydrate)

Behavioral

Zone diet (low carbohydrate, high protein)

Behavioral

Ornish diet (very low fat)

Behavioral

Primary outcomes

  1. Weight; measured at each study visit

  2. Percent body fat; measured at each study visit

Secondary outcomes

  1. Blood lipids (cholesterol, triglycerides); measured at each study visit

  2. Fasting insulin and glucose; measured at each study visit

  3. Behavioral variables; measured at each study visit

Sponsors and collaborators

Lead sponsor

National Center for Complementary and Integrative Health (NCCIH)

Nih

Collaborators

  • Community Foundation of Southeastern Michigan

Registry information

Official study title

Benefits & Risks of Popular Weight Loss Diets

Important dates

Study start
2002
Study completion
2004
First posted
Mar 10, 2004
Registry last updated
Aug 18, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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