the Effect of a Red Rice Nutrition Supplement on Cholesterol Levels

NCT ID: NCT01558050

Last Updated: 2012-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cholesterol Level HDL Level LDL Level TG Level

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

red rice

commercially available red rice nutritionial supplement

Group Type EXPERIMENTAL

red rice supplement

Intervention Type DIETARY_SUPPLEMENT

patricipants take a red rice supplement or placebo daily for 8 weeks

placebo

placebo capsules

Group Type PLACEBO_COMPARATOR

red rice supplement

Intervention Type DIETARY_SUPPLEMENT

patricipants take a red rice supplement or placebo daily for 8 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

red rice supplement

patricipants take a red rice supplement or placebo daily for 8 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* total fasting cholesterol \> 200mg/dl
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universiteit Antwerpen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Veronique Verhoeven

professor dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Antwerp

Wilrijk, , Belgium

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium

References

Explore related publications, articles, or registry entries linked to this study.

Verhoeven V, Lopez Hartmann M, Remmen R, Wens J, Apers S, Van Royen P. Red yeast rice lowers cholesterol in physicians - a double blind, placebo controlled randomized trial. BMC Complement Altern Med. 2013 Jul 18;13:178. doi: 10.1186/1472-6882-13-178.

Reference Type DERIVED
PMID: 23866314 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RR001

Identifier Type: -

Identifier Source: org_study_id