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Effects of Limicol on LDL-cholesterol

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ClinicalTrials.gov Identifier: NCT01354327
Recruitment Status : Completed
First Posted : May 16, 2011
Last Update Posted : May 16, 2011
Sponsor:
Collaborators:
CIC Hôpital de la Conception - Marseille
Aix Marseille Université
Information provided by:
Lescuyer Laboratory

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Study of the Effects of Limicol (a Food Supplement) on LDL-cholesterol in Moderate Hypercholesterolemia Subjects
Study Start Date : December 2008
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Limicol Dietary Supplement: Limicol
3 tablets / day during 4 months
Placebo Comparator: Placebo Dietary Supplement: Placebo
3 tablets / day during 4 months



Primary Outcome Measures :
  1. Change from Baseline in blood LDL-cholesterol levels at 4 months [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. Change from Baseline in blood Vit. C, Vit. E, polyphenols and MDA levels at 4 months [ Time Frame: 4 months ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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

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): NCT01354327


Locations
France
Morange
Marseille, France, 13005
Sponsors and Collaborators
Lescuyer Laboratory
CIC Hôpital de la Conception - Marseille
Aix Marseille Université
Investigators
Study Director: Sébastien Peltier, PhD Lescuyer Laboratory

Responsible Party: Peltier, Lescuyer Laboratory
ClinicalTrials.gov Identifier: NCT01354327     History of Changes
Other Study ID Numbers: 2008-A01169-46
First Posted: May 16, 2011    Key Record Dates
Last Update Posted: May 16, 2011
Last Verified: May 2011

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