Effect of LIMICOL®-NG on Plasma LDL-cholesterol Concentration in Subjects with Moderate Hypercholesterolemia

NCT ID: NCT06894251

Last Updated: 2025-03-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-10
• Study Completion Date: 2025-12-01

Brief Summary

The goal of this clinical trial is to observe a decrease in plasma LDL cholesterol concentration of 10% (or 0.20g/L) in subjects with untreated moderate hypercholesterolemia after 3 months of consumption of the Limicol®-NG food supplement, compared with a historical placebo group

Detailed Description

The objective is to evaluate the effect of the Limicol®-NG food supplement during the 3 months of taking it (after 1 and 3 months of consumption versus T0) and comparison versus placebo history of the evolution over time (from 0 to 3 months) of the following parameters:

• Weight,
• BMI,
• Waist circumference,
• Systolic and diastolic blood pressures,
• Resting heart rate.
• Fasting blood sugar
• LDL cholesterol
• Non-HDL cholesterol (NHC)
• Total cholesterol (TC)
• HDL cholesterol
• Triglycerides (TG)
• LDL/HDL and TC/HDL ratios,
• Safety parameters measured from blood samples at VS and V2: ASAT, ALAT, Gamma-GT, Creatine Kinase, Lactate DeHydrogenase, Bilirubin, Creatinine, and Urea.

Conditions

Healthy Volunteer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Food supplement group

Two tablets of Limicol®-NG per day (1 during or after breakfast and 1 during or after dinner) Food supplements are consumed during 3 months by healthy volunteers

Group Type: EXPERIMENTAL

LIMICOL® NG

Intervention Type: DIETARY_SUPPLEMENT

All subjects will consume 2 tablets per day during the entire intervention period, i.e. 12 weeks between V0 and V2, distributed as follows: 1 tablet in the morning at the end of or after breakfast (no taking on an empty stomach) and 1 tablet in the evening during dinner. If a dose is missed, 2 tablets can be taken at the next dose.

Interventions

LIMICOL® NG

All subjects will consume 2 tablets per day during the entire intervention period, i.e. 12 weeks between V0 and V2, distributed as follows: 1 tablet in the morning at the end of or after breakfast (no taking on an empty stomach) and 1 tablet in the evening during dinner. If a dose is missed, 2 tablets can be taken at the next dose.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• For women

• If pre-menopausal: effective non-estrogenic contraception established for at least 2 cycles, to be maintained during the study,
• If menopausal: without estrogenic Hormone Replacement Therapy (HRT)
• LDL cholesterol >1.3 g/L (according to Friedewald calculation);
• Having stable eating habits, a level of physical activity and a weight for at least 3 months before the start of the study;
• Agreeing to maintain their lifestyle habits throughout the duration of the study;
• Agreeing to follow the constraints generated by the study;
• Having signed the informed consent form;
• Social security insured.

Exclusion Criteria

• Subjects receiving hypolipidemic or anti-dyslipidemic treatment (statin, ezetimibe, cholestyramine, fibrate, etc.)
• Subjects presenting triglyceridemia > 4g/L (Friedewald)
• Subject requiring immediate treatment with statin
• Subject requiring immediate dietary intervention or having fluctuating eating behavior
• Diabetic subjects treated or not with medication
• Subjects with unstable treatment (for less than three months), or requiring the implementation of treatment during the study which, according to the investigator, could interfere with the evaluation of the study criteria (efficacy: LDL, TG, HDL, blood sugar, blood pressure, weight; safety: markers of liver, muscle or kidney function)
• Subjects who have consumed in the last 3 months food supplements or functional foods that could impact cholesterol or TG levels (phytosterol, phytostanol, red yeast rice, policosanols, beta-glucans at a dose greater than 3 g/day, probiotics)
• Subjects suffering from a severe chronic condition deemed incompatible with the study by the investigator (serious digestive pathologies, renal failure, coronary pathology, immunodeficiency, heart failure, rhythm disorders, progressive tumor pathology, blood disease)
• Subject suffering from a severe eating disorder (anorexia, bulimia, binge eating disorder)
• Pregnant woman or planning to become pregnant during the study period or breastfeeding
• Whose state of health or concomitant treatments are judged by the principal investigator or a qualified co-investigator to be incompatible with the proper conduct of the clinical study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institut Pasteur de Lille

OTHER

Sponsor Role: lead

Responsible Party

Coralie BERTHIER

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Frédéric Batteux, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Pasteur de Lille

Locations

NutrInvest - Institut Pasteur de Lille

Lille, Nord, France

Site Status: RECRUITING

Countries

France

Central Contacts

Coralie Berthier, PhD

Role: CONTACT

coralie.berthier@pasteur-lille.fr

3 20 87 73 33 ext. +33

Frédéric Batteux, MD

Role: CONTACT

frederic.batteux@pasteur-lille.fr

3.20.87.73.16 ext. +33

Facility Contacts

Frédéric Batteux, MD

Role: primary

frederic.batteux@pasteur-lille.fr

3.20.87.73.16 ext. +33

Coralie Berthier, PhD

Role: backup

coralie.berthier@pasteur-lille.fr

3.20.87.73.33 ext. +33

Other Identifiers

2024-A01916-41

Identifier Type: -

Identifier Source: org_study_id