Dose Effect of Limicol on (LDL)-Cholesterol Levels

NCT ID: NCT01354340

Last Updated: 2012-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hypercholesterolaemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Limicol simple dose

Group Type EXPERIMENTAL

Limicol

Intervention Type DIETARY_SUPPLEMENT

3 tablets (Limicol) + 3 tablets (Placebo) / day during 1 month and follow-up 1 month without treatment

Limicol double doses

Group Type EXPERIMENTAL

Limicol

Intervention Type DIETARY_SUPPLEMENT

6 tablets (Limicol) / day during 1 month and follow-up 1 month without treatment

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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Limicol

3 tablets (Limicol) + 3 tablets (Placebo) / day during 1 month and follow-up 1 month without treatment

Intervention Type DIETARY_SUPPLEMENT

Limicol

6 tablets (Limicol) / day during 1 month and follow-up 1 month without treatment

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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BioFortis

OTHER

Sponsor Role collaborator

Lescuyer Laboratory

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sebastien Peltier, PhD

Role: STUDY_DIRECTOR

Lescuyer Laboratory

Locations

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Biofortis

Nantes, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 23266743 (View on PubMed)

Other Identifiers

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2011-A00145-36

Identifier Type: -

Identifier Source: org_study_id

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