Effects of Limicol on LDL-cholesterol

May 13, 2011 updated by: Lescuyer Laboratory

Study of the Effects of Limicol (a Food Supplement) on LDL-cholesterol in Moderate Hypercholesterolemia Subjects

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France, 13005
        • Morange

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Dietary supplement: Placebo
3 tablets / day during 4 months
Experimental: Limicol
Dietary supplement: Limicol
3 tablets / day during 4 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in blood LDL-cholesterol levels at 4 months
Time Frame: 4 months
4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in blood Vit. C, Vit. E, polyphenols and MDA levels at 4 months
Time Frame: 4 months
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lescuyer Laboratory

Collaborators

Aix Marseille Université
CIC Hôpital de la Conception - Marseille

Investigators

  • Study Director: Sebastien Peltier, PhD, Lescuyer Laboratory

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

May 13, 2011

First Submitted That Met QC Criteria

May 13, 2011

First Posted (Estimate)

May 16, 2011

Study Record Updates

Last Update Posted (Estimate)

May 16, 2011

Last Update Submitted That Met QC Criteria

May 13, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-A01169-46

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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