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Completed

NCT Number: NCT01354340

Dose Effect of Limicol on (LDL)-Cholesterol Levels

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.

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Key information

Conditions

Hypercholesterolaemia Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Dyslipidemias Heart Diseases Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Myocardial Ischemia Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Biofortis

Nantes, 44000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LIMICOL

Dietary Supplement

3 tablets (Limicol) + 3 tablets (Placebo) / day during 1 month and follow-up 1 month without treatment

Placebo

Other

6 tablets (Placebo) / day during 1 month and follow-up 1 month without treatment

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Lescuyer Laboratory

Industry

Collaborators

  • BioFortis

Registry information

Official study title

Dose Effect of Limicol on (LDL)-Cholesterol Levels in Moderate Hypercholesterolaemia

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
May 16, 2011
Registry last updated
Apr 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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