the Effect of a Red Rice Nutrition Supplement on Cholesterol Levels

Cholesterol Level Clinical Trial

Official title:

The Effect of a Commercially Available Red Rice Nutrition Supplement on Serum Lipids

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01558050
• Other study ID #: RR001
• Status: Completed
• Phase: Phase 4
• First received: March 16, 2012
• Last updated: September 13, 2012
• Start date: March 2012
• Est. completion date: September 2012

Study information

• Verified date: September 2012
• Source: Universiteit Antwerpen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review BoardBelgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: September 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• total fasting cholesterol > 200mg/dl

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholesterol Level
• HDL Level
• LDL Level
• TG Level

Intervention

Dietary Supplement:
• red rice supplement
patricipants take a red rice supplement or placebo daily for 8 weeks

Locations

Country	Name	City	State
Belgium	University of Antwerp	Wilrijk

Sponsors (1)

Lead Sponsor	Collaborator
Universiteit Antwerpen

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fasting cholesterol, LDL, HDL, TG level		8 weeks	No