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Effects of Limicol on LDL-cholesterol

Primary Purpose

Hypercholesteremia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Limicol
Placebo
Sponsored by
Lescuyer Laboratory
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesteremia focused on measuring Delivery of Health Care, Cholesterol, LDL-cholesterol, Coronary artery disease, Red yeast rice, Plants extract, Cholesterol excess

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Morange

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Limicol

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 13, 2011
Last Updated
May 13, 2011
Sponsor
Lescuyer Laboratory
Collaborators
CIC Hôpital de la Conception - Marseille, Aix Marseille Université
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1. Study Identification

Unique Protocol Identification Number
NCT01354327
Brief Title
Effects of Limicol on LDL-cholesterol
Official Title
Study of the Effects of Limicol (a Food Supplement) on LDL-cholesterol in Moderate Hypercholesterolemia Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Lescuyer Laboratory
Collaborators
CIC Hôpital de la Conception - Marseille, Aix Marseille Université

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesteremia
Keywords
Delivery of Health Care, Cholesterol, LDL-cholesterol, Coronary artery disease, Red yeast rice, Plants extract, Cholesterol excess

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Limicol
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Limicol
Intervention Description
3 tablets / day during 4 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
3 tablets / day during 4 months
Primary Outcome Measure Information:
Title
Change from Baseline in blood LDL-cholesterol levels at 4 months
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Change from Baseline in blood Vit. C, Vit. E, polyphenols and MDA levels at 4 months
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sébastien Peltier, PhD
Organizational Affiliation
Lescuyer Laboratory
Official's Role
Study Director
Facility Information:
Facility Name
Morange
City
Marseille
ZIP/Postal Code
13005
Country
France

12. IPD Sharing Statement

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Effects of Limicol on LDL-cholesterol

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