NCT01354327

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2008

Typical duration 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

December 1, 2008

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

May 13, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 16, 2011

Completed
Last Updated

May 16, 2011

Status Verified

May 1, 2011

Enrollment Period

2.4 years

First QC Date

May 13, 2011

Last Update Submit

May 13, 2011

Conditions

Hypercholesteremia

Keywords

Delivery of Health CareCholesterolLDL-cholesterolCoronary artery diseaseRed yeast ricePlants extractCholesterol excess

Outcome Measures

Primary Outcomes (1)

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

    4 months

Secondary Outcomes (1)

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

    4 months

Study Arms (2)

Limicol

EXPERIMENTAL
Dietary Supplement: Limicol

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

LimicolDIETARY_SUPPLEMENT

3 tablets / day during 4 months

Limicol
PlaceboDIETARY_SUPPLEMENT

3 tablets / day during 4 months

Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Morange

Marseille, 13005, France

Location

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

  • Sébastien 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

Study Record Dates

First Submitted

May 13, 2011

First Posted

May 16, 2011

Study Start

December 1, 2008

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

May 16, 2011

Record last verified: 2011-05

Locations

FR(1)