- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00625235
A High Protein Diet and Weight Maintenance
February 19, 2008 updated by: University of Melbourne
The Use of a High Protein Diet in Achieving Long-Term Weight Loss and Improved Cardiovascular Risk Factors
An investigation into long term weight maintenance using a high protein or high carbohydrate diet, after a large and rapid weight loss.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
180
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Victoria
-
Heidelberg, Victoria, Australia, 3081
- Department of Medicine, Heidelberg Repatriation Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 1
High Carbohydrate diet
|
|
Other: 2
High Protein diet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Body weight
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cardiovascular risk factors
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2003
Primary Completion (Actual)
January 1, 2006
Study Completion (Actual)
January 1, 2006
Study Registration Dates
First Submitted
February 19, 2008
First Submitted That Met QC Criteria
February 19, 2008
First Posted (Estimate)
February 28, 2008
Study Record Updates
Last Update Posted (Estimate)
February 28, 2008
Last Update Submitted That Met QC Criteria
February 19, 2008
Last Verified
June 1, 2003
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HREC 2003.046
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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