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the Effect of a Red Rice Nutrition Supplement on Cholesterol Levels

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Veronique Verhoeven, Universiteit Antwerpen
ClinicalTrials.gov Identifier:
NCT01558050
First received: March 16, 2012
Last updated: September 13, 2012
Last verified: September 2012
History of Changes
  Purpose

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 Intervention Phase
Cholesterol Level
HDL Level
LDL Level
TG Level
 Dietary Supplement: red rice supplement
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of a Commercially Available Red Rice Nutrition Supplement on Serum Lipids

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Universiteit Antwerpen:

Primary Outcome Measures:
  • fasting cholesterol, LDL, HDL, TG level [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: March 2012
Study Completion Date: September 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • total fasting cholesterol > 200mg/dl
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01558050

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

No publications provided

Responsible Party: Veronique Verhoeven, professor dr, Universiteit Antwerpen
ClinicalTrials.gov Identifier: NCT01558050     History of Changes
Other Study ID Numbers: RR001
Study First Received: March 16, 2012
Last Updated: September 13, 2012
Health Authority: Belgium: Institutional Review Board
Belgium: Ethics Committee

ClinicalTrials.gov processed this record on May 16, 2013