Dose Effect of Limicol on (LDL)-Cholesterol Levels

Sponsor

Lescuyer Laboratory (Industry)

Overall Status

Completed

CT.gov ID

NCT01354340

Collaborator

BioFortis (Other)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypercholesterolaemia	Dietary Supplement: Limicol Dietary Supplement: Limicol Other: Placebo	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

45 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2011

Actual Primary Completion Date :

Dec 1, 2011

Actual Study Completion Date :

Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Limicol simple dose	Dietary Supplement: Limicol 3 tablets (Limicol) + 3 tablets (Placebo) / day during 1 month and follow-up 1 month without treatment
Experimental: Limicol double doses	Dietary Supplement: Limicol 6 tablets (Limicol) / day during 1 month and follow-up 1 month without treatment
Placebo Comparator: Placebo	Other: Placebo 6 tablets (Placebo) / day during 1 month and follow-up 1 month without treatment

Arm

Intervention/Treatment

Experimental: Limicol simple dose

Dietary Supplement: Limicol

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

Experimental: Limicol double doses

Dietary Supplement: Limicol

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

Placebo Comparator: Placebo

Other: Placebo

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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.