Text Size

Effects of Limicol on LDL-cholesterol

This study has been completed.
Sponsor:
Collaborators:
CIC Hôpital de la Conception - Marseille
UMR INRA 1260/INSERM U476/Universités Aix-Marseille I et II
Information provided by:
Lescuyer Laboratory
ClinicalTrials.gov Identifier:
NCT01354327
First received: May 13, 2011
Last updated: NA
Last verified: May 2011
History: No changes posted
  Purpose

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.


Condition Intervention
Hypercholesteremia
 Dietary Supplement: Limicol
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Study of the Effects of Limicol (a Food Supplement) on LDL-cholesterol in Moderate Hypercholesterolemia Subjects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Lescuyer Laboratory:

Primary Outcome Measures:
  • Change from Baseline in blood LDL-cholesterol levels at 4 months [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline in blood Vit. C, Vit. E, polyphenols and MDA levels at 4 months [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Enrollment: 47
Study Start Date: December 2008
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Limicol Dietary Supplement: Limicol
3 tablets / day during 4 months
Placebo Comparator: Placebo Dietary Supplement: Placebo
3 tablets / day during 4 months

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01354327

Locations
France
Morange
Marseille, France, 13005
Sponsors and Collaborators
Lescuyer Laboratory
CIC Hôpital de la Conception - Marseille
UMR INRA 1260/INSERM U476/Universités Aix-Marseille I et II
Investigators
Study Director: Sébastien Peltier, PhD Lescuyer Laboratory
  More Information

No publications provided

Responsible Party: Peltier, Lescuyer Laboratory
ClinicalTrials.gov Identifier: NCT01354327     History of Changes
Other Study ID Numbers: 2008-A01169-46
Study First Received: May 13, 2011
Last Updated: May 13, 2011
Health Authority: France: Committee for the Protection of Personnes
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Lescuyer Laboratory:
Delivery of Health Care
Cholesterol
LDL-cholesterol
Coronary artery disease
 Red yeast rice
Plants extract
Cholesterol excess

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 16, 2013