A High Protein Diet and Weight Maintenance | NCT00625235

Studies
A High Protein Diet and Weight Maintenance

NCT00625235

Sponsor

University of Melbourne

Status

Completed

Last Update Posted

Feb 28, 2008Estimated

Enrollment

180

Phase

Not Applicable

Conditions

Obesity

Interventions

VLED followed by a high protein or high carbohydrate diet

Countries

Australia

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

Jun 2003

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 2003

Primary Completion Date

Jan 2006Actual

Completion Date

Jan 2006Actual

First Submitted Date

Feb 19, 2008

First Submission Date that Met QC Criteria

Feb 19, 2008

First Posted Date

Feb 28, 2008Estimated

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

Feb 19, 2008

Last Update Posted Date

Feb 28, 2008Estimated

Name	Class
Meat and Livestock Australia	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

An investigation into long term weight maintenance using a high protein or high carbohydrate diet, after a large and rapid weight loss.

Detailed Description

Not provided

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

180

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Other	High Carbohydrate diet	Dietary Supplement: VLED followed by a high protein or high carbohydrate diet
2	Other	High Protein diet	Dietary Supplement: VLED followed by a high protein or high carbohydrate diet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
VLED followed by a high protein or high carbohydrate diet	Dietary Supplement		1 2

Measure	Description	Time Frame
Body weight		12 months

Measure	Description	Time Frame
Cardiovascular risk factors		12 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy men and women with a BMI >27kg/m2 with co-morbities or BMI >30kg/m2

Exclusion Criteria:

people with Type II diabetes or other endocrine disorders, women who were pregnant or breastfeeding or planning to become pregnant

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Medicine, Heidelberg Repatriation Hospital		Heidelberg	Victoria	3081	Australia

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity
D015431	Weight Loss

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided