Cholesterol LevelPhase 4NCT01558050
the Effect of a Red Rice Nutrition Supplement on Cholesterol Levels
A Phase 4 study testing red rice supplement in people with Cholesterol Level and HDL Level, run by Universiteit Antwerpen at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cholesterol Level, HDL Level, LDL Level
- What is being tested?
- red rice supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2012to Sep 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- total fasting cholesterol > 200mg/dl
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of a Commercially Available Red Rice Nutrition Supplement on Serum Lipids
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.
- Conditions
- Cholesterol Level, HDL Level, LDL Level, TG Level
- Being tested
- red rice supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
red rice supplementDietary supplement
patricipants take a red rice supplement or placebo daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| red rice | Experimental | commercially available red rice nutritionial supplement Receives: Dietary Supplement: red rice supplement |
| placebo | Placebo comparator | placebo capsules Receives: Dietary Supplement: red rice supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
fasting cholesterol, LDL, HDL, TG level
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionJun 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cholesterol LevelStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Veronique Verhoeven, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01558050
- Sponsor's protocol ID
- RR001
- Status last verified
- Sep 2012
- First submitted
- 16 Mar 2012
- Last updated
- 17 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23866314
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Commercially Available Red Rice Nutrition Supplement on Serum Lipids
- ClinicalTrials.gov ID
- NCT01558050
- Acronym / sponsor ID
- RR001
- Conditions
- Cholesterol Level, HDL Level, LDL Level, TG Level
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 20 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| red rice | Experimental | Dietary Supplement: red rice supplementcommercially available red rice nutritionial supplement |
| placebo | Placebo comparator | Dietary Supplement: red rice supplementplacebo capsules |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- total fasting cholesterol > 200mg/dl
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| red rice supplementpatricipants take a red rice supplement or placebo daily for 8 weeks | Dietary supplement | placebo, red rice |
Primary outcome
fasting cholesterol, LDL, HDL, TG level
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2012.
- Derived from this study: PubMed 23866314Verhoeven 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing red rice supplement in people with Cholesterol Level and HDL Level, run by Universiteit Antwerpen at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fasting cholesterol, LDL, HDL, TG level (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01558050, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2012.