NCT01139398

Brief Summary

The purpose of this study is to validate the effectiveness of food supplement Limicol on reducing LDL-cholesterol in moderate hypercholesterolemic volunteers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2010

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

May 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 7, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 8, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

February 22, 2012

Status Verified

February 1, 2012

Enrollment Period

1.5 years

First QC Date

June 7, 2010

Last Update Submit

February 21, 2012

Conditions

Delivery of Health Care

Keywords

CholesterolLDL-cholesterolCoronary artery diseaseRed yeast ricePlants extractCholesterol excess.

Outcome Measures

Primary Outcomes (1)

  • LDL-cholesterol levels

    4 months

Secondary Outcomes (1)

  • Total cholesterol, HDL-cholesterol, triglycerides levels

    4 months

Interventions

Limicol (plant extract)DIETARY_SUPPLEMENT

Artichoke extract, anti-caking agents: dicalcium phosphate, calcium citrate, vegetable magnesium stearate, red yeast rice, microcrystalline cellulose, natural vitamin E, garlic extract, sugar cane policosanols, inositol hexanicotinate, vitamin B3, vitamin B2.

Also known as: Limicol

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, 44200, France

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Plant Extracts

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological ProductsComplex MixturesPharmaceutical Preparations

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

June 7, 2010

First Posted

June 8, 2010

Study Start

May 1, 2010

Primary Completion

November 1, 2011

Study Completion

January 1, 2012

Last Updated

February 22, 2012

Record last verified: 2012-02

Locations

FR(1)