Dose Effect of Limicol on (LDL)-Cholesterol Levels

Not Applicable

Completed

• Conditions: Hypercholesterolaemia
• Interventions: Dietary Supplement: Limicol; Other: Placebo

• Registration Number: NCT01354340
• Lead Sponsor: Lescuyer Laboratory

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-05-12
• Study First Submitted QC: 2011-05-13
• Study First Posted: 2011-05-16
• Primary Completion: 2011-12
• Study Completion: 2012-01
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-18
• Last Update Posted: 2012-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Limicol simple dose	Limicol	-
Limicol double doses	Limicol	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Biofortis; 🇫🇷 Nantes, France