Comparison of Popular Weight Loss Diets

Obesity Clinical Trial

Official title:

Benefits & Risks of Popular Weight Loss Diets

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00079573
• Other study ID #: R21AT001098-01A1
• Status: Completed
• Phase: Phase 2
• First received: March 9, 2004
• Last updated: August 16, 2006
• Start date: July 2002
• Est. completion date: June 2004

Study information

• Verified date: August 2006
• Source: National Center for Complementary and Integrative Health (NCCIH)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: June 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 50 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Behavioral:
• Atkins diet (extremely low carbohydrate)

• Zone diet (low carbohydrate, high protein)

• Ornish diet (very low fat)

Locations

Country	Name	City	State
United States	Stanford Prevention Research Center	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
National Center for Complementary and Integrative Health (NCCIH)	Community Foundation of Southeastern Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight; measured at each study visit
Primary	Percent body fat; measured at each study visit
Secondary	Blood lipids (cholesterol, triglycerides); measured at each study visit
Secondary	Fasting insulin and glucose; measured at each study visit
Secondary	Behavioral variables; measured at each study visit

External Links

•   Stanford Center for Research in Disease Prevention