Comparison of Popular Weight Loss Diets | NCT00079573

Studies
Comparison of Popular Weight Loss Diets

NCT00079573

Sponsor

National Center for Complementary and Integrative Health (NCCIH)

Status

Completed

Last Update Posted

Aug 18, 2006Estimated

Enrollment

300

Phase

Phase 2

Conditions

Obesity

Interventions

Atkins diet (extremely low carbohydrate)
Zone diet (low carbohydrate, high protein)
Ornish diet (very low fat)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2002

Primary Completion Date

Not provided

Completion Date

Jun 2004

First Submitted Date

Mar 9, 2004

First Submission Date that Met QC Criteria

Mar 9, 2004

First Posted Date

Mar 10, 2004Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 16, 2006

Last Update Posted Date

Aug 18, 2006Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

National Center for Complementary and Integrative Health (NCCIH)NIH

Collaborators

Name	Class
Community Foundation of Southeastern Michigan	UNKNOWN

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Atkins diet (extremely low carbohydrate)	Behavioral
Zone diet (low carbohydrate, high protein)	Behavioral
Ornish diet (very low fat)	Behavioral

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Weight; measured at each study visit
Percent body fat; measured at each study visit

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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)

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christopher D. Gardner, PhD	Stanford University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford Prevention Research Center		Stanford	California	94305	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17341711	Derived	Gardner CD, Kiazand A, Alhassan S, Kim S, Stafford RS, Balise RR, Kraemer HC, King AC. Comparison of the Atkins, Zone, Ornish, and LEARN diets for change in weight and related risk factors among overweight premenopausal women: the A TO Z Weight Loss Study: a randomized trial. JAMA. 2007 Mar 7;297(9):969-77. doi: 10.1001/jama.297.9.969.

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight

ID	Term
D050528	Diet, Carbohydrate-Restricted
D004035	Diet Therapy
D044623	Nutrition Therapy
D013812	Therapeutics