Effects of Limicol on LDL-cholesterol

Sponsor

Lescuyer Laboratory (Industry)

Overall Status

Completed

CT.gov ID

NCT01354327

Collaborator

CIC Hôpital de la Conception - Marseille (Other), Aix Marseille Université (Other)

Enrollment

Location

Arms

28.9

Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

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

Study Design

Study Type:

Interventional

Actual Enrollment :

47 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2008

Actual Primary Completion Date :

May 1, 2011

Actual Study Completion Date :

May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Limicol	Dietary Supplement: Limicol 3 tablets / day during 4 months
Placebo Comparator: Placebo	Dietary Supplement: Placebo 3 tablets / day during 4 months

Arm

Intervention/Treatment

Experimental: Limicol

Dietary Supplement: Limicol

3 tablets / day during 4 months

Placebo Comparator: Placebo

Dietary Supplement: Placebo

3 tablets / day during 4 months

Outcome Measures

Primary Outcome Measures

Change from Baseline in blood LDL-cholesterol levels at 4 months [4 months]

Secondary Outcome Measures

Change from Baseline in blood Vit. C, Vit. E, polyphenols and MDA levels at 4 months [4 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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