Dose Effect of Limicol on (LDL)-Cholesterol Levels

Hypercholesterolaemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01354340
• Other study ID #: 2011-A00145-36
• Status: Completed
• Phase: N/A
• First received: May 12, 2011
• Last updated: April 18, 2012
• Start date: April 2011
• Est. completion date: January 2012

Study information

• Verified date: April 2012
• Source: Lescuyer Laboratory
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: French Health Products Safety Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: January 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolaemia
• Hypercholesterolemia

Intervention

Dietary Supplement:
• Limicol
3 tablets (Limicol) + 3 tablets (Placebo) / day during 1 month and follow-up 1 month without treatment
• Limicol
6 tablets (Limicol) / day during 1 month and follow-up 1 month without treatment

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

Locations

Country	Name	City	State
France	Biofortis	Nantes

Sponsors (2)

Lead Sponsor	Collaborator
Lescuyer Laboratory	BioFortis

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in blood LDL-cholesterol levels after 4 weeks of supplementation (limicol double dose group versus placebo group)		4 weeks after baseline	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes