HypercholesteremiaNCT01354327
Effects of Limicol on LDL-cholesterol
A study testing Limicol in people with Hypercholesteremia, run by Lescuyer Laboratory at 1 site in France.
Trial summary
The principal objective of this study is to investigate the effects of a novel food supplement (Limicol) on LDL-cholesterol levels in healthy subjects with moderate hypercholesterolemia. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesteremia
- 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
- 47 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2008to May 2011
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- About 18 to 55 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: Study of the Effects of Limicol (a Food Supplement) on LDL-cholesterol in Moderate Hypercholesterolemia Subjects
The principal objective of this study is to investigate the effects of a novel food supplement (Limicol) on LDL-cholesterol levels in healthy subjects with moderate hypercholesterolemia.
- Conditions
- Hypercholesteremia
- Being tested
- Limicol, Placebo
- Keywords
- Delivery of Health Care, Cholesterol, LDL-cholesterol, Coronary artery disease, Red yeast rice, Plants extract, Cholesterol excess
- 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 / day during 4 months
PlaceboDietary supplement
3 tablets / day during 4 months
| Study group | Role | What they receive |
|---|---|---|
| Limicol | Experimental | Not described Receives: Dietary Supplement: Limicol |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: 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 at 4 months
Measured: 4 months
Secondary outcomes (1)
Change from Baseline in blood Vit. C, Vit. E, polyphenols and MDA levels at 4 months
Measured: 4 months
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 startDec 2008
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesteremiaStudies 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
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lescuyer Laboratory
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CIC Hôpital de la Conception - Marseille, Aix Marseille Université
- Investigators
- Sébastien Peltier, PhD, Study director, Lescuyer Laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01354327
- Sponsor's protocol ID
- 2008-A01169-46
- Status last verified
- May 2011
- First submitted
- 13 May 2011
- Last updated
- 16 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effects of Limicol (a Food Supplement) on LDL-cholesterol in Moderate Hypercholesterolemia Subjects
- ClinicalTrials.gov ID
- NCT01354327
- Acronym / sponsor ID
- 2008-A01169-46
- Conditions
- Hypercholesteremia
- Keywords
- Delivery of Health Care, Cholesterol, LDL-cholesterol, Coronary artery disease, Red yeast rice, Plants extract, Cholesterol excess
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Lescuyer LaboratoryIndustry (pharma, biotech, devices)
- Collaborators
- CIC Hôpital de la Conception - Marseille, Aix Marseille Université
- Study start
- Dec 2008
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (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 effects of a novel food supplement (Limicol) on LDL-cholesterol levels in healthy subjects with moderate hypercholesterolemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Limicol | Experimental | Dietary Supplement: Limicol |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- About 18 to 55 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 / day during 4 months | Dietary supplement | Limicol |
| Placebo3 tablets / day during 4 months | Dietary supplement | Placebo |
Primary outcome
Change from Baseline in blood LDL-cholesterol levels at 4 months
Time frame: 4 months
1 secondary outcome
Change from Baseline in blood Vit. C, Vit. E, polyphenols and MDA levels at 4 months
Time frame: 4 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 16 May 2011.
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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.
Sébastien 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 Hypercholesteremia, 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 16 May 2011. 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 at 4 months (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2011.