NCT01558050

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2012

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 20, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

September 17, 2012

Status Verified

September 1, 2012

Enrollment Period

3 months

First QC Date

March 16, 2012

Last Update Submit

September 13, 2012

Conditions

Cholesterol LevelHDL LevelLDL LevelTG Level

Outcome Measures

Primary Outcomes (1)

  • fasting cholesterol, LDL, HDL, TG level

    8 weeks

Study Arms (2)

red rice

EXPERIMENTAL

commercially available red rice nutritionial supplement

Dietary Supplement: red rice supplement

placebo

PLACEBO COMPARATOR

placebo capsules

Dietary Supplement: red rice supplement

Interventions

red rice supplementDIETARY_SUPPLEMENT

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

placebored rice

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • total fasting cholesterol \> 200mg/dl

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Antwerp

Wilrijk, 2610, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 23866314DERIVED

MeSH Terms

Interventions

red yeast rice

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor dr

Study Record Dates

First Submitted

March 16, 2012

First Posted

March 20, 2012

Study Start

March 1, 2012

Primary Completion

June 1, 2012

Study Completion

September 1, 2012

Last Updated

September 17, 2012

Record last verified: 2012-09

Locations

BE(1)