NCT01354340

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 12, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 16, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

April 19, 2012

Status Verified

April 1, 2012

Enrollment Period

8 months

First QC Date

May 12, 2011

Last Update Submit

April 18, 2012

Conditions

Hypercholesterolaemia

Keywords

CholesterolLDL-cholesterolCoronary artery diseaseRed yeast ricePlants extractCholesterol excessDelivery of Health Care

Outcome Measures

Primary Outcomes (1)

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

    4 weeks after baseline

Secondary Outcomes (4)

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

    4 weeks after baseline

  • 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)

    4 weeks after baseline

  • 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)

    8 weeks after baseline

  • 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)

    4 weeks after baseline

Study Arms (3)

Limicol simple dose

EXPERIMENTAL
Dietary Supplement: Limicol

Limicol double doses

EXPERIMENTAL
Dietary Supplement: Limicol

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

LimicolDIETARY_SUPPLEMENT

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

Limicol simple dose
PlaceboOTHER

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

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biofortis

Nantes, 44000, France

Location

Related Publications (1)

  • 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.

    PMID: 23266743DERIVED

MeSH Terms

Conditions

HypercholesterolemiaCoronary Artery Disease

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Sebastien Peltier, PhD

    Lescuyer Laboratory

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2011

First Posted

May 16, 2011

Study Start

April 1, 2011

Primary Completion

December 1, 2011

Study Completion

January 1, 2012

Last Updated

April 19, 2012

Record last verified: 2012-04

Locations

FR(1)