HypercholesterolaemiaNCT01354340
Dose Effect of Limicol on (LDL)-Cholesterol Levels
A study testing Limicol in people with Hypercholesterolaemia, run by Lescuyer Laboratory at 1 site in France.
Trial summary
The principal objective of this study is to investigate the dose-effect of the Limicol food supplement on LDL-cholesterol level in moderate hypercholesterolaemia subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolaemia
- What is being tested?
- Limicol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2011to Jan 2012
- Phase
- Interventional
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- About 18 to 65 years (inclusive).
- Subject has a stable weight for at least three months before the start of the study.
- Subject able and willing to comply with the protocol and agreeing to give their consent in writing.
- Subject affiliated with a social security scheme.
- Subject willing to be included in the national register of volunteers who lend themselves to biomedical research.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dose Effect of Limicol on (LDL)-Cholesterol Levels in Moderate Hypercholesterolaemia
The principal objective of this study is to investigate the dose-effect of the Limicol food supplement on LDL-cholesterol level in moderate hypercholesterolaemia subjects.
- Conditions
- Hypercholesterolaemia
- Being tested
- Limicol, Placebo
- Keywords
- Cholesterol, LDL-cholesterol, Coronary artery disease, Red yeast rice, Plants extract, Cholesterol excess, Delivery of Health Care
- Medical subject headings
- Hypercholesterolemia, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LimicolDietary supplement
3 tablets (Limicol) + 3 tablets (Placebo) / day during 1 month and follow-up 1 month without treatment
LimicolDietary supplement
6 tablets (Limicol) / day during 1 month and follow-up 1 month without treatment
PlaceboOther
6 tablets (Placebo) / day during 1 month and follow-up 1 month without treatment
| Study group | Role | What they receive |
|---|---|---|
| Limicol simple dose | Experimental | Not described Receives: Dietary Supplement: Limicol |
| Limicol double doses | Experimental | Not described Receives: Dietary Supplement: Limicol |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in blood LDL-cholesterol levels after 4 weeks of supplementation (limicol double dose group versus placebo group)
Measured: 4 weeks after baseline
Secondary outcomes (4)
Change from Baseline in blood LDL-cholesterol levels after 4 weeks of supplementation (limicol double dose group versus limicol simple dose group)
Measured: 4 weeks after baseline
Change from Baseline in blood total cholesterol, HDL-cholesterol and TAG levels after 4 weeks of supplementation (limicol double dose group versus limicol simple dose group versus placebo group)
Measured: 4 weeks after baseline
Change from Baseline in blood LDL-cholesterol, total cholesterol, HDL-cholesterol and TAG levels 4 weeks after end of supplementation (limicol double dose group versus limicol simple dose group versus placebo group)
Measured: 8 weeks after baseline
Change from Baseline in CK, LDH and other safety biomarkers levels after 4 weeks of supplementation (limicol double dose group versus placebo group versus placebo group)
Measured: 4 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2011 (estimated)
- Study startApr 2011
- Primary completionDec 2011
- Study completionJan 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 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lescuyer Laboratory
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioFortis
- Responsible party
- Sponsor
- Investigators
- Sebastien Peltier, PhD, Study director, Lescuyer Laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01354340
- Sponsor's protocol ID
- 2011-A00145-36
- Status last verified
- Apr 2012
- First submitted
- 12 May 2011
- Last updated
- 19 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Barrat E, Zair Y, Sirvent P, Chauveau P, Maudet C, Housez B, Derbord E, Lescuyer JF, Bard JM, Cazaubiel M, Peltier SL. Effect on LDL-cholesterol of a large dose of a dietary supplement with plant extracts in subjects with untreated moderate hypercholesterolaemia: a randomised, double-blind, placebo-controlled study. Eur J Nutr. 2013 Dec;52(8):1843-52. doi: 10.1007/s00394-012-0486-2. Epub 2012 Dec 25.
PubMed 23266743
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Effect of Limicol on (LDL)-Cholesterol Levels in Moderate Hypercholesterolaemia
- ClinicalTrials.gov ID
- NCT01354340
- Acronym / sponsor ID
- 2011-A00145-36
- Conditions
- Hypercholesterolaemia
- Keywords
- Cholesterol, LDL-cholesterol, Coronary artery disease, Red yeast rice, Plants extract, Cholesterol excess, Delivery of Health Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Lescuyer LaboratoryIndustry (pharma, biotech, devices)
- Collaborators
- BioFortis
- Study start
- Apr 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 16 May 2011 (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.
The principal objective of this study is to investigate the dose-effect of the Limicol food supplement on LDL-cholesterol level in moderate hypercholesterolaemia subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Limicol simple dose | Experimental | Dietary Supplement: Limicol |
| Limicol double doses | Experimental | Dietary Supplement: Limicol |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- About 18 to 65 years (inclusive).
- Subject has a stable weight for at least three months before the start of the study.
- Subject able and willing to comply with the protocol and agreeing to give their consent in writing.
- Subject affiliated with a social security scheme.
- Subject willing to be included in the national register of volunteers who lend themselves to biomedical research.
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 |
|---|---|---|
| Limicol3 tablets (Limicol) + 3 tablets (Placebo) / day during 1 month and follow-up 1 month without treatment | Dietary supplement | Limicol simple dose |
| Limicol6 tablets (Limicol) / day during 1 month and follow-up 1 month without treatment | Dietary supplement | Limicol double doses |
| Placebo6 tablets (Placebo) / day during 1 month and follow-up 1 month without treatment | Other | Placebo |
Primary outcome
Change from Baseline in blood LDL-cholesterol levels after 4 weeks of supplementation (limicol double dose group versus placebo group)
Time frame: 4 weeks after baseline
4 secondary outcomes
Change from Baseline in blood LDL-cholesterol levels after 4 weeks of supplementation (limicol double dose group versus limicol simple dose group)
Time frame: 4 weeks after baseline
Change from Baseline in blood total cholesterol, HDL-cholesterol and TAG levels after 4 weeks of supplementation (limicol double dose group versus limicol simple dose group versus placebo group)
Time frame: 4 weeks after baseline
Change from Baseline in blood LDL-cholesterol, total cholesterol, HDL-cholesterol and TAG levels 4 weeks after end of supplementation (limicol double dose group versus limicol simple dose group versus placebo group)
Time frame: 8 weeks after baseline
Change from Baseline in CK, LDH and other safety biomarkers levels after 4 weeks of supplementation (limicol double dose group versus placebo group versus placebo group)
Time frame: 4 weeks after baseline
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 19 Apr 2012.
- Derived from this study: PubMed 23266743Barrat E, Zair Y, Sirvent P, Chauveau P, Maudet C, Housez B, Derbord E, Lescuyer JF, Bard JM, Cazaubiel M, Peltier SL. Effect on LDL-cholesterol of a large dose of a dietary supplement with plant extracts in subjects with untreated moderate hypercholesterolaemia: a randomised, double-blind, placebo-controlled study. Eur J Nutr. 2013 Dec;52(8):1843-52. doi: 10.1007/s00394-012-0486-2. Epub 2012 Dec 25.
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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.
Sebastien Peltier, PhD study director
Lescuyer Laboratory
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Limicol in people with Hypercholesterolaemia, run by Lescuyer Laboratory at 1 site in France.
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 5 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 19 Apr 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 France. 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.
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?
Change from Baseline in blood LDL-cholesterol levels after 4 weeks of supplementation (limicol double dose group versus placebo group) (time frame: 4 weeks after baseline). 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 NCT01354340, 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 19 Apr 2012.