Dose Effect of Limicol on (LDL)-Cholesterol Levels

Lescuyer Laboratory45 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Hypercholesterolaemia

Interventions

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Biofortis

Nantes, France

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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