Dose Effect of Limicol on (LDL)-Cholesterol Levels

Dose Effect of Limicol on (LDL)-Cholesterol Levels in Moderate Hypercholesterolaemia

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01354340

Enrollment

Registered

2011-05-16

Start date

2011-04-30

Completion date

2012-01-31

Last updated

2012-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolaemia

Keywords

Cholesterol, LDL-cholesterol, Coronary artery disease, Red yeast rice, Plants extract, Cholesterol excess, Delivery of Health Care

Brief 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.

Interventions

DIETARY_SUPPLEMENTLimicol

3 tablets (Limicol) + 3 tablets (Placebo) / day during 1 month and follow-up 1 month without treatment

OTHERPlacebo

6 tablets (Placebo) / day during 1 month and follow-up 1 month without treatment

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame
Change from Baseline in blood LDL-cholesterol levels after 4 weeks of supplementation (limicol double dose group versus placebo group)	4 weeks after baseline

Secondary

Measure	Time frame
Change from Baseline in blood LDL-cholesterol levels after 4 weeks of supplementation (limicol double dose group versus limicol simple dose group)	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)	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)	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)	4 weeks after baseline

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026