A High Protein Diet and Weight Maintenance

Obesity Clinical Trial

Official title:

The Use of a High Protein Diet in Achieving Long-Term Weight Loss and Improved Cardiovascular Risk Factors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00625235
• Other study ID #: HREC 2003.046
• Status: Completed
• Phase: N/A
• First received: February 19, 2008
• Last updated: February 19, 2008
• Start date: July 2003
• Est. completion date: January 2006

Study information

• Verified date: June 2003
• Source: University of Melbourne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: January 2006
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

Dietary Supplement:
• VLED followed by a high protein or high carbohydrate diet

Locations

Country	Name	City	State
Australia	Department of Medicine, Heidelberg Repatriation Hospital	Heidelberg	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
University of Melbourne	Meat and Livestock Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight		12 months	No
Secondary	Cardiovascular risk factors		12 months	No