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
  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:


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
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, see Learn About Clinical Studies.

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 July 24, 2014