HypercholesterolemiaL2012-12NCT05750602

Combined Effect of LIMICOL and Physical Activity on LDL Cholesterol and Muscle Function.

A study testing LIMICOL in people with Hypercholesterolemia, run by Lescuyer Laboratory at 4 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Hypercholesterolemia
What is being tested?: LIMICOL
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 4 sitesFrance
Study dates: Nov 2013to Sep 2018
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

BMI between 25 and 35 kg/m²
Subject has a stable weight for at least three months before the start of the study.
LDL ≥ 1.50 g/L
0.9 g/L ≤ triglycerides ≤ 4.00 g/L
Subject able and willing to comply with the protocol and agreeing to give his informed consent in writing;
Subject affiliated with a social security scheme

Who cannot join

Subject having a confirmed or suspected food allergy, notably to one of the components of the study product;
Subject suffering from a severe chronic condition deemed incompatible with participation in the study by the investigator
Subject with glaucoma
Subject with uretroprostatic disorder
Subjet anxious (score >9 HAD scale)
Subject with diabetes
Subjet with treatment anticoagulant

Trial locations and contacts

4 sites in 1 country.

France4 sites

Clermont Université, Université Blaise Pascal, EA 3533, Laboratoire des Adaptations Métaboliques à l'Exercice en Conditions Physiologiques et Pathologiques (AME2P), BP 10448
Clermont-Ferrand, F-63000
CRNH-Auvergne
Clermont-Ferrand, F-63001
Service de médecine du sport et des explorations fonctionnelles, CHU G. Montpied
Clermont-Ferrand, F-63003
Clinique de cardiopneumologie de DURTOL
Durtol, F-63830

Other trials in France

About this study

Official title: Effect of the Food Supplement LIMICOL on LDL Cholesterol and Muscle Function in Subjects Who Undergo a Program of Physical Training (Double-blind, Randomized, Placebo-controlled Study).

Cardiovascular disease (CVD), foremost among which ischemic heart disease and stroke, are the leading cause of mortality and morbidity in France. These diseases are multifactorial origin and even if it is not possible to act on risk markers such as age, sex, or heredity, risk factors like high cholesterol, smoking , hypertension, obesity, diabetes and physical inactivity, are the main target of prevention strategies. Dydlipidemias have a role in the formation of CVD in participating in the genesis of atherosclerosis. The cholesterol and LDL-cholesterol in particular is subject to oxidation process in plasma. The molecules of oxidized LDL-cholesterol, small and dense, easily penetrate the arterial endothelial wall and are greeted by macrophages. Following a succession of different processes including inflammation, atherosclerotic plaque is formed. The result is either an arteriopathy when the arterial lumen narrowing, or atherothrombosis in the event of plaque rupture. Given this pathophysiology, reduce blood lipids, including LDL-cholesterol and reducing oxidation and inflammation are interesting strategies in the context of cardiovascular prevention. Several scientific study showed that nutritional supplementation with some plant extracts such as artichokes, garlic, red yeast rice, or the sugar cane policosanol helps to reduce several cardiovascular risk factors including regulate concentrations of circulating lipids.

In this study, we hypothesize that the food supplement LIMICOL contributes to reducing LDL cholesterol in the context of care for patients (dietary measures and physical activity)

Conditions: Hypercholesterolemia
Being tested: LIMICOL, PLACEBO
Keywords: Hypercholesterolemia, LDL cholesterol
Medical subject headings: Hypercholesterolemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LIMICOLDietary supplement
Suplementation with LIMICOL, 3 tablets per day, together with supervised physical activity (3 times per week) for 12 weeks.
PLACEBODietary supplement
Suplementation with PLACEBO, 3 tablets per day, together with supervised physical activity (3 times per week) for 12 weeks.

Study groups in NCT05750602
Study group	Role	What they receive
LIMICOL	Experimental	LIMICOL : red yeast rice (with monacolin K, 2 mg), artichoke leaf extract, policosanols, French maritime Pine bark extract, Garlic extract, vitamins E, B2 and B3. 1 tablet during the 3 principal meals for 12 weeks. Receives: Dietary Supplement: LIMICOL
PLACEBO	Placebo comparator	dicalcium phosphate, calcium citrate, vegetable magnesium stearate, microcrystalline cellulose, Maltodextrin, Tricalcium phosphate, Beet powder, Yellow coloring shellac, Brown coloring shellac. 1 tablet during the 3 principal meals for 12 weeks. Receives: Dietary Supplement: PLACEBO

What is being measured

The primary outcome is the main question the study is designed to answer.

LDL-cholesterol levels (g/l) at the end of study
Effect of LIMICOL supplementation showed by ANCOVA analysis of LDL cholesterol (g/l), with baseline LDL as covariable
Measured: Week 12

Secondary outcomes (27)

Muscle function on tissue biopsy
Mitochondrial respiration of muscle histology. Expressed as pmol/s/ml.
Measured: Week 0; Week 12
Total cholesterol
Total cholesterol. Expressed as g/l, variation (g/l and %) compared to baseline.
Measured: Week 0; Week 6; Week 12
HDL-cholesterol
HDL. Expressed as g/l, variation (g/l and %) compared to baseline.
Measured: Week 0; Week 6; Week 12
Triglycerides
Triglycerides. Expressed as g/l, variation (g/l and %) compared to baseline.
Measured: Week 0; Week 6; Week 12
LDLox
oxydized LDL. Expressed as pg/ml, variation (pg/l and %) compared to baseline.
Measured: Week 0; Week 6; Week 12
CoQ10
circulating coenzyme Q10. Expressed as pg/ml. variation (pg/l and %) compared to baseline.
Measured: Week 0; Week 12
ApoA1
Circulating ApoLipoprotein A1. Expressed as g/ml. variation (g/l and %) compared to baseline.
Measured: Week 0; Week 12
ApoB
Circulating ApoLipoprotein B. Expressed as g/ml. variation (g/l and %) compared to baseline.
Measured: Week 0; Week 12
Glycemia
Glycemia. Expressed as mmol/l. variation (mmol/l and %) compared to baseline.
Measured: Week 0; Week 12
Insulinemia
Insulinemia. Expressed as mUI/l. variation (mUI/l and %) compared to baseline.
Measured: Week 0; Week 12
Myoglobin
Myoglobin. Expressed as µgI/l. variation (µg/l and %) compared to baseline.
Measured: Week 0; Week 12
CK
Creatin kinase. Expressed as UI/l. variation (UI/l and %) compared to baseline.
Measured: Week 0; Week 12
LD
Lactate Dehydrogenase. Expressed as UI/l. variation (UI/l and %) compared to baseline.
Measured: Week 0; Week 12
AST
Aspartate transaminase. Expressed as UI/l. variation (UI/l and %) compared to baseline.
Measured: Week 0; Week 12
ALT
Alanine transaminase. Expressed as UI/l. variation (UI/l and %) compared to baseline.
Measured: Week 0; Week 12
ALP
Alkaline phosphatase. Expressed as UI/l. variation (UI/l and %) compared to baseline.
Measured: Week 0; Week 12
GGT
Gamma-glutamyltransferase. Expressed as UI/l. variation (UI/l and %) compared to baseline.
Measured: Week 0; Week 12
Bilirubin
Bilirubin. Expressed as µmol/l. variation (µmol/l and %) compared to baseline.
Measured: Week 0; Week 12
Albumin
Albumin. Expressed as g/l. variation (g/l and %) compared to baseline.
Measured: Week 0; Week 12
Total Protein
Total Protein. Expressed as g/l. variation (g/l and %) compared to baseline.
Measured: Week 0; Week 12
usCRP
ultrasensible C-reactiv protein. Expressed as mg/l. variation (mg/l and %) compared to baseline.
Measured: Week 0; Week 12
Creatinin
Creatinin. Expressed as µmol/l. variation (µmol/l and %) compared to baseline.
Measured: Week 0; Week 12
Urea
Urea. Expressed as µmol/l. variation (µmol/l and %) compared to baseline.
Measured: Week 0; Week 12
VO2 MAX
VO2MAX. Expressed as ml/min/kg. variation (ml/min/kg and %) compared to baseline.
Measured: Week 0; Week 6; Week 12
Max Strength
Max grip strength. Expressed as N. variation (N and %) compared to baseline.
Measured: Week 0; Week 6; Week 12
Weight
Body Weight. Expressed as Kg. variation (Kg and %) compared to baseline.
Measured: Week 0; Week 6; Week 12
Fat mass
Fat Mass measured by DEXA. Expressed as % body mass. variation (%) compared to baseline.
Measured: Week 0; Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2013Sep 2018

First posted1 Mar 2023
Study startNov 2013
Primary completionJul 2017
Study completionSep 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05750602
Sponsor's protocol ID: 2013-A00061-44
Acronym: L2012-12
Status last verified: Feb 2023
First submitted: 8 Sep 2014
Last updated: 1 Mar 2023
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia

All Hypercholesterolemia trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of the Food Supplement LIMICOL on LDL Cholesterol and Muscle Function in Subjects Who Undergo a Program of Physical Training (Double-blind, Randomized, Placebo-controlled Study).
ClinicalTrials.gov ID: NCT05750602
Acronym / sponsor ID: L2012-12 / 2013-A00061-44
Conditions: Hypercholesterolemia
Keywords: Hypercholesterolemia, LDL cholesterol
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Lescuyer LaboratoryIndustry (pharma, biotech, devices)
Collaborators: Hopital Gabriel Montpied, Centre de Recherche en Nutrition Humaine d'Auvergne, Clinical Of Medical Cardio Pneumologie, Durtol, Université d'Auvergne
Study start: Nov 2013 (actual)
Primary completion: Jul 2017 (actual)
Study completion: Sep 2018 (actual)
First posted: 1 Mar 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

In this study, we hypothesize that the food supplement LIMICOL contributes to reducing LDL cholesterol in the context of care for patients (dietary measures and physical activity)

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
LIMICOL	Experimental	Dietary Supplement: LIMICOLLIMICOL : red yeast rice (with monacolin K, 2 mg), artichoke leaf extract, policosanols, French maritime Pine bark extract, Garlic extract, vitamins E, B2 and B3. 1 tablet during the 3 principal meals for 12 weeks.
PLACEBO	Placebo comparator	Dietary Supplement: PLACEBOdicalcium phosphate, calcium citrate, vegetable magnesium stearate, microcrystalline cellulose, Maltodextrin, Tricalcium phosphate, Beet powder, Yellow coloring shellac, Brown coloring shellac. 1 tablet during the 3 principal meals for 12 weeks.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

BMI between 25 and 35 kg/m²
Subject has a stable weight for at least three months before the start of the study.
LDL ≥ 1.50 g/L
0.9 g/L ≤ triglycerides ≤ 4.00 g/L
Subject able and willing to comply with the protocol and agreeing to give his informed consent in writing;

Key exclusion criteria (7 listed)

Subject having a confirmed or suspected food allergy, notably to one of the components of the study product;
Subject suffering from a severe chronic condition deemed incompatible with participation in the study by the investigator
Subject with glaucoma
Subject with uretroprostatic disorder
Subjet anxious (score >9 HAD scale)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LIMICOLSuplementation with LIMICOL, 3 tablets per day, together with supervised physical activity (3 times per week) for 12 weeks.	Dietary supplement	LIMICOL
PLACEBOSuplementation with PLACEBO, 3 tablets per day, together with supervised physical activity (3 times per week) for 12 weeks.	Dietary supplement	PLACEBO

Primary outcome

LDL-cholesterol levels (g/l) at the end of study
Time frame: Week 12
Effect of LIMICOL supplementation showed by ANCOVA analysis of LDL cholesterol (g/l), with baseline LDL as covariable

27 secondary outcomes

Muscle function on tissue biopsy
Time frame: Week 0; Week 12
Total cholesterol
Time frame: Week 0; Week 6; Week 12
HDL-cholesterol
Time frame: Week 0; Week 6; Week 12
Triglycerides
Time frame: Week 0; Week 6; Week 12
LDLox
Time frame: Week 0; Week 6; Week 12
CoQ10
Time frame: Week 0; Week 12
ApoA1
Time frame: Week 0; Week 12
ApoB
Time frame: Week 0; Week 12
Glycemia
Time frame: Week 0; Week 12
Insulinemia
Time frame: Week 0; Week 12
Myoglobin
Time frame: Week 0; Week 12
CK
Time frame: Week 0; Week 12
LD
Time frame: Week 0; Week 12
AST
Time frame: Week 0; Week 12
ALT
Time frame: Week 0; Week 12
ALP
Time frame: Week 0; Week 12
GGT
Time frame: Week 0; Week 12
Bilirubin
Time frame: Week 0; Week 12
Albumin
Time frame: Week 0; Week 12
Total Protein
Time frame: Week 0; Week 12
usCRP
Time frame: Week 0; Week 12
Creatinin
Time frame: Week 0; Week 12
Urea
Time frame: Week 0; Week 12
VO2 MAX
Time frame: Week 0; Week 6; Week 12
Max Strength
Time frame: Week 0; Week 6; Week 12
Weight
Time frame: Week 0; Week 6; Week 12
Fat mass
Time frame: Week 0; Week 12

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.

Related trials for Hypercholesterolemia

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Martine Duclos, Pr principal investigator

CHU G. Montpied

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing LIMICOL in people with Hypercholesterolemia, run by Lescuyer Laboratory at 4 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

LDL-cholesterol levels (g/l) at the end of study (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05750602.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.