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
  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:


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
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: 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 by Lescuyer Laboratory

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 July 22, 2014