ClinicalTrials.gov
ClinicalTrials.gov Menu

the Effect of a Red Rice Nutrition Supplement on Cholesterol Levels

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01558050
Recruitment Status : Completed
First Posted : March 20, 2012
Last Update Posted : September 17, 2012
Sponsor:
Information provided by (Responsible Party):
Veronique Verhoeven, Universiteit Antwerpen

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Cholesterol Level HDL Level LDL Level TG Level Dietary Supplement: red rice supplement Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of a Commercially Available Red Rice Nutrition Supplement on Serum Lipids
Study Start Date : March 2012
Actual Primary Completion Date : June 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: red rice
commercially available red rice nutritionial supplement
Dietary Supplement: red rice supplement
patricipants take a red rice supplement or placebo daily for 8 weeks
Placebo Comparator: placebo
placebo capsules
Dietary Supplement: red rice supplement
patricipants take a red rice supplement or placebo daily for 8 weeks



Primary Outcome Measures :
  1. fasting cholesterol, LDL, HDL, TG level [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • total fasting cholesterol > 200mg/dl

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01558050


Locations
Belgium
University of Antwerp
Wilrijk, Belgium, 2610
Sponsors and Collaborators
Universiteit Antwerpen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Veronique Verhoeven, professor dr, Universiteit Antwerpen
ClinicalTrials.gov Identifier: NCT01558050     History of Changes
Other Study ID Numbers: RR001
First Posted: March 20, 2012    Key Record Dates
Last Update Posted: September 17, 2012
Last Verified: September 2012