HypercholesterolaemiaPhase 4NCT02065180
The Effect of a Red Rice and Olive Extract Nutrition Supplement on Cholesterol Levels in Patients With Metabolic Syndrome
A Phase 4 study testing commercially available nutrition supplement in people with Hypercholesterolaemia, run by Universiteit Antwerpen at 1 site in Belgium.
Trial summary
This randomised controlled trial studies the effect of a commercially available nutritional supplement on cholesterol levels in people with metabolic syndrome and elevated cholesterol levels. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolaemia
- What is being tested?
- commercially available nutrition supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2014to May 2014
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- metabolic syndrome according to ATPIII criteria 3 of the following:
- waist circumference >88cm (in females) or >102cm (in males)
- triglycerides >150mg/dl
- HDL <40 (50)mg/dl in males (females)
- blood pressure>130/85 or treatment for AHT
- glucose >110mg/dl
Who cannot join
- pregnancy
- treatment with cholesterol lowering drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of a Red Rice and Olive Extract Nutrition Supplement on Cholesterol
This randomised controlled trial studies the effect of a commercially available nutritional supplement on cholesterol levels in people with metabolic syndrome and elevated cholesterol levels.
- Conditions
- Hypercholesterolaemia
- Being tested
- commercially available nutrition supplement, placebo
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
commercially available nutrition supplementDietary supplement
the food supplement contains red rice yeast and olive extract
placeboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| commercially available nutrition supplement | Experimental | this group receives a commercially available nutritional supplement for a period of 2 months Receives: Dietary Supplement: commercially available nutrition supplement |
| control group | Placebo comparator | this group receives a placebo for a period of 2 months Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL level
Measured: 2 months
total cholesterol level
Measured: 2 months
triglyceride level
Measured: 2 months
HDL level
Measured: 2 months
Secondary outcomes (6)
OxLDL
Measured: 2 months
BMI
Measured: 2 months
malondialdehyde (MDA)
Measured: 2 months
8-OH-deoxyguanosine (8-OHdG)
Measured: 2 months
side effects
Measured: 2 months
waist circumference
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolaemiaStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 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
- NCT02065180
- Sponsor's protocol ID
- verhoevenhermans
- Status last verified
- May 2014
- First submitted
- 13 Feb 2014
- Last updated
- 20 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Hermans N, Van der Auwera A, Breynaert A, Verlaet A, De Bruyne T, Van Gaal L, Pieters L, Verhoeven V. A red yeast rice-olive extract supplement reduces biomarkers of oxidative stress, OxLDL and Lp-PLA2, in subjects with metabolic syndrome: a randomised, double-blind, placebo-controlled trial. Trials. 2017 Jul 3;18(1):302. doi: 10.1186/s13063-017-2058-5.
PubMed 28673363Verhoeven V, Van der Auwera A, Van Gaal L, Remmen R, Apers S, Stalpaert M, Wens J, Hermans N. Can red yeast rice and olive extract improve lipid profile and cardiovascular risk in metabolic syndrome?: A double blind, placebo controlled randomized trial. BMC Complement Altern Med. 2015 Mar 10;15:52. doi: 10.1186/s12906-015-0576-9.
PubMed 25879228
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Red Rice and Olive Extract Nutrition Supplement on Cholesterol
- ClinicalTrials.gov ID
- NCT02065180
- Acronym / sponsor ID
- verhoevenhermans
- Conditions
- Hypercholesterolaemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 17 Feb 2014 (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.
This randomised controlled trial studies the effect of a commercially available nutritional supplement on cholesterol levels in people with metabolic syndrome and elevated cholesterol levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| commercially available nutrition supplement | Experimental | Dietary Supplement: commercially available nutrition supplementthis group receives a commercially available nutritional supplement for a period of 2 months |
| control group | Placebo comparator | Dietary Supplement: placebothis group receives a placebo for a period of 2 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- metabolic syndrome according to ATPIII criteria 3 of the following:
Key exclusion criteria (2 listed)
- pregnancy
- treatment with cholesterol lowering drugs
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 |
|---|---|---|
| commercially available nutrition supplementthe food supplement contains red rice yeast and olive extract | Dietary supplement | commercially available nutrition supplement |
| placebo | Dietary supplement | control group |
Primary outcome
LDL level
Time frame: 2 months
total cholesterol level
Time frame: 2 months
triglyceride level
Time frame: 2 months
HDL level
Time frame: 2 months
6 secondary outcomes
OxLDL
Time frame: 2 months
BMI
Time frame: 2 months
malondialdehyde (MDA)
Time frame: 2 months
8-OH-deoxyguanosine (8-OHdG)
Time frame: 2 months
side effects
Time frame: 2 months
waist circumference
Time frame: 2 months
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 20 May 2014.
- Derived from this study: PubMed 28673363Hermans N, Van der Auwera A, Breynaert A, Verlaet A, De Bruyne T, Van Gaal L, Pieters L, Verhoeven V. A red yeast rice-olive extract supplement reduces biomarkers of oxidative stress, OxLDL and Lp-PLA2, in subjects with metabolic syndrome: a randomised, double-blind, placebo-controlled trial. Trials. 2017 Jul 3;18(1):302. doi: 10.1186/s13063-017-2058-5.
- Derived from this study: PubMed 25879228Verhoeven V, Van der Auwera A, Van Gaal L, Remmen R, Apers S, Stalpaert M, Wens J, Hermans N. Can red yeast rice and olive extract improve lipid profile and cardiovascular risk in metabolic syndrome?: A double blind, placebo controlled randomized trial. BMC Complement Altern Med. 2015 Mar 10;15:52. doi: 10.1186/s12906-015-0576-9.
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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 commercially available nutrition supplement in people with Hypercholesterolaemia, 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 6 inclusion and 2 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 20 May 2014. 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?
LDL level (time frame: 2 months). The study lists 4 primary outcomes in all. 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 NCT02065180, which also lists 2 linked publications.
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 20 May 2014.