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Dose Effect of Limicol on (LDL)-Cholesterol Levels

This study has been completed.
Sponsor:
Collaborator:
BioFortis
Information provided by (Responsible Party):
Lescuyer Laboratory
ClinicalTrials.gov Identifier:
NCT01354340
First received: May 12, 2011
Last updated: April 18, 2012
Last verified: April 2012
History of Changes
  Purpose

The principal objective of this study is to investigate the dose-effect of the Limicol food supplement on LDL-cholesterol level in moderate hypercholesterolaemia subjects.


Condition Intervention
Hypercholesterolaemia
 Dietary Supplement: Limicol
Other: 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: Dose Effect of Limicol on (LDL)-Cholesterol Levels in Moderate Hypercholesterolaemia

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol
U.S. FDA Resources

Further study details as provided by Lescuyer Laboratory:

Primary Outcome Measures:
  • Change from Baseline in blood LDL-cholesterol levels after 4 weeks of supplementation (limicol double dose group versus placebo group) [ Time Frame: 4 weeks after baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline in blood LDL-cholesterol levels after 4 weeks of supplementation (limicol double dose group versus limicol simple dose group) [ Time Frame: 4 weeks after baseline ] [ Designated as safety issue: No ]
  • Change from Baseline in blood total cholesterol, HDL-cholesterol and TAG levels after 4 weeks of supplementation (limicol double dose group versus limicol simple dose group versus placebo group) [ Time Frame: 4 weeks after baseline ] [ Designated as safety issue: No ]
  • Change from Baseline in blood LDL-cholesterol, total cholesterol, HDL-cholesterol and TAG levels 4 weeks after end of supplementation (limicol double dose group versus limicol simple dose group versus placebo group) [ Time Frame: 8 weeks after baseline ] [ Designated as safety issue: No ]
  • Change from Baseline in CK, LDH and other safety biomarkers levels after 4 weeks of supplementation (limicol double dose group versus placebo group versus placebo group) [ Time Frame: 4 weeks after baseline ] [ Designated as safety issue: Yes ]

Enrollment: 45
Study Start Date: April 2011
Study Completion Date: January 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Limicol simple dose Dietary Supplement: Limicol
3 tablets (Limicol) + 3 tablets (Placebo) / day during 1 month and follow-up 1 month without treatment
Experimental: Limicol double doses Dietary Supplement: Limicol
6 tablets (Limicol) / day during 1 month and follow-up 1 month without treatment
Placebo Comparator: Placebo Other: Placebo
6 tablets (Placebo) / day during 1 month and follow-up 1 month without treatment

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01354340

Locations
France
Biofortis
Nantes, France, 44000
Sponsors and Collaborators
Lescuyer Laboratory
BioFortis
Investigators
Study Director: Sebastien Peltier, PhD Lescuyer Laboratory
  More Information

No publications provided

Responsible Party: Lescuyer Laboratory
ClinicalTrials.gov Identifier: NCT01354340     History of Changes
Other Study ID Numbers: 2011-A00145-36
Study First Received: May 12, 2011
Last Updated: April 18, 2012
Health Authority: France: Committee for the Protection of Personnes
France: French Health Products Safety Agency

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

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

ClinicalTrials.gov processed this record on May 16, 2013