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Dose Effect of Limicol on (LDL)-Cholesterol Levels

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ClinicalTrials.gov Identifier: NCT01354340
Recruitment Status : Completed
First Posted : May 16, 2011
Last Update Posted : April 19, 2012
Sponsor:
Collaborator:
BioFortis
Information provided by (Responsible Party):
Lescuyer Laboratory

Brief Summary:
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 or disease Intervention/treatment Phase
Hypercholesterolaemia Dietary Supplement: Limicol Other: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Dose Effect of Limicol on (LDL)-Cholesterol Levels in Moderate Hypercholesterolaemia
Study Start Date : April 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01354340


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

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
First Posted: May 16, 2011    Key Record Dates
Last Update Posted: April 19, 2012
Last Verified: April 2012

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