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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014