Effects of Limicol on LDL-cholesterol

Hypercholesteremia Clinical Trial

Official title:

Study of the Effects of Limicol (a Food Supplement) on LDL-cholesterol in Moderate Hypercholesterolemia Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01354327
• Other study ID #: 2008-A01169-46
• Status: Completed
• Phase: N/A
• First received: May 13, 2011
• Last updated: May 13, 2011
• Start date: December 2008
• Est. completion date: May 2011

Study information

• Verified date: May 2011
• Source: Lescuyer Laboratory
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

The principal objective of this study is to investigate the effects of a novel food supplement (Limicol) on LDL-cholesterol levels in healthy subjects with moderate hypercholesterolemia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• About 18 to 55 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

• Hypercholesteremia
• Hypercholesterolemia

Intervention

Dietary Supplement:
• Limicol
3 tablets / day during 4 months
• Placebo
3 tablets / day during 4 months

Locations

Country	Name	City	State
France	Morange	Marseille

Sponsors (3)

Lead Sponsor	Collaborator
Lescuyer Laboratory	Aix Marseille Université, CIC Hôpital de la Conception - Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in blood LDL-cholesterol levels at 4 months		4 months	No
Secondary	Change from Baseline in blood Vit. C, Vit. E, polyphenols and MDA levels at 4 months		4 months	No