- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01558050
the Effect of a Red Rice Nutrition Supplement on Cholesterol Levels
September 13, 2012 updated by: Veronique Verhoeven, Universiteit Antwerpen
The Effect of a Commercially Available Red Rice Nutrition Supplement on Serum Lipids
In this study the investigators investigate the effect of a red rice product on plasma lipids in a sample of physicians and/or their family members.
After a baseline measurement of cholesterol, HDL, LDL and TG, participants are randomised to receive a commercially available red rice product or placebo. After a period of 8 weeks, lipid levels are measured again.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
52
Phase
- Phase 4
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
-
-
-
Wilrijk, Belgium, 2610
- University of Antwerp
-
-
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
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- total fasting cholesterol > 200mg/dl
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
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: placebo
placebo capsules
|
patricipants take a red rice supplement or placebo daily for 8 weeks
|
Experimental: red rice
commercially available red rice nutritionial supplement
|
patricipants take a red rice supplement or placebo daily for 8 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
fasting cholesterol, LDL, HDL, TG level
Time Frame: 8 weeks
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
March 1, 2012
Primary Completion (Actual)
June 1, 2012
Study Completion (Actual)
September 1, 2012
Study Registration Dates
First Submitted
March 16, 2012
First Submitted That Met QC Criteria
March 16, 2012
First Posted (Estimate)
March 20, 2012
Study Record Updates
Last Update Posted (Estimate)
September 17, 2012
Last Update Submitted That Met QC Criteria
September 13, 2012
Last Verified
September 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- RR001
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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