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Dose Effect of Limicol on (LDL)-Cholesterol Levels

Primary Purpose

Hypercholesterolaemia

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

About this trial

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

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Biofortis

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Limicol simple dose

Limicol double doses

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change from Baseline in blood LDL-cholesterol levels after 4 weeks of supplementation (limicol double dose group versus placebo group)

Secondary Outcome Measures

Change from Baseline in blood LDL-cholesterol levels after 4 weeks of supplementation (limicol double dose group versus limicol simple dose group)
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)
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)
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)

Full Information

First Posted
May 12, 2011
Last Updated
April 18, 2012
Sponsor
Lescuyer Laboratory
Collaborators
BioFortis
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1. Study Identification

Unique Protocol Identification Number
NCT01354340
Brief Title
Dose Effect of Limicol on (LDL)-Cholesterol Levels
Official Title
Dose Effect of Limicol on (LDL)-Cholesterol Levels in Moderate Hypercholesterolaemia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lescuyer Laboratory
Collaborators
BioFortis

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Limicol simple dose
Arm Type
Experimental
Arm Title
Limicol double doses
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Limicol
Intervention Description
3 tablets (Limicol) + 3 tablets (Placebo) / day during 1 month and follow-up 1 month without treatment
Intervention Type
Dietary Supplement
Intervention Name(s)
Limicol
Intervention Description
6 tablets (Limicol) / day during 1 month and follow-up 1 month without treatment
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
6 tablets (Placebo) / day during 1 month and follow-up 1 month without treatment
Primary Outcome Measure Information:
Title
Change from Baseline in blood LDL-cholesterol levels after 4 weeks of supplementation (limicol double dose group versus placebo group)
Time Frame
4 weeks after baseline
Secondary Outcome Measure Information:
Title
Change from Baseline in blood LDL-cholesterol levels after 4 weeks of supplementation (limicol double dose group versus limicol simple dose group)
Time Frame
4 weeks after baseline
Title
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)
Time Frame
4 weeks after baseline
Title
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)
Time Frame
8 weeks after baseline
Title
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)
Time Frame
4 weeks after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebastien Peltier, PhD
Organizational Affiliation
Lescuyer Laboratory
Official's Role
Study Director
Facility Information:
Facility Name
Biofortis
City
Nantes
ZIP/Postal Code
44000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
23266743
Citation
Barrat E, Zair Y, Sirvent P, Chauveau P, Maudet C, Housez B, Derbord E, Lescuyer JF, Bard JM, Cazaubiel M, Peltier SL. Effect on LDL-cholesterol of a large dose of a dietary supplement with plant extracts in subjects with untreated moderate hypercholesterolaemia: a randomised, double-blind, placebo-controlled study. Eur J Nutr. 2013 Dec;52(8):1843-52. doi: 10.1007/s00394-012-0486-2. Epub 2012 Dec 25.
Results Reference
derived

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Dose Effect of Limicol on (LDL)-Cholesterol Levels

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