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

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

Study Overview

• Status: Recruiting
• Conditions: Healthy Volunteer
• Intervention / Treatment: Dietary supplement: LIMICOL® NG

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.

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Coralie Berthier, PhD; Phone Number: +33 3 20 87 73 33; Email: coralie.berthier@pasteur-lille.fr
• Study Contact Backup: Name: Frédéric Batteux, MD; Phone Number: +33 3.20.87.73.16; Email: frederic.batteux@pasteur-lille.fr

Study Locations

• France
  • Nord
    • Lille, Nord, France, 59019
      • Recruiting
      • NutrInvest - Institut Pasteur de Lille
      • Contact: Frédéric Batteux, MD; Phone Number: +33 3.20.87.73.16; Email: frederic.batteux@pasteur-lille.fr
      • Contact: Coralie Berthier, PhD; Phone Number: +33 3.20.87.73.33; Email: coralie.berthier@pasteur-lille.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evolution over time (from 0 to 3 months) of the plasma concentration of LDL cholesterol	Historical placebo comparison of the evolution over time (from 0 to 3 months) of plasma LDL cholesterol concentration measured according to the Friedwald method (in g/L and %).	To baseline at 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	Anthropometric parameters: weight (unit: kg)	0 month (baseline), 1 month, 3 months
Body Mass Index	Anthropometric parameters: determined Body Mass Index (unit: kg/m²)	0 month (baseline), 1 month, 3 months
Waist circumference	Waist circumference (unit: cm)	0 month (baseline), 1 month, 3 months
Blood pressure	Hemodynamic parameters: Systolic blood pressure (unit: mm Hg) and Diastolic blood pressure (unit: mm Hg)	0 month (baseline), 1 month, 3 months
Heart rate	Hemodynamic parameters: Heart rate (unit: Pul/min)	0 month (baseline), 1 month, 3 months
Fasting glycemia	Carbohydrate metabolism: Fasting glycemia (unit: g/l)	0 month (baseline), 1 month, 3 months
Lipid metabolism	Total cholesterol, HDL, LDL, non-HDL, Triglycerides, LDL/HDL ratio and TC/HDL ratio (unit: g/l)	0 month (baseline), 1 month, 3 months
Hepatic metabolism	Creatinine, bilirubin (unit: mg/dl)	0 month (baseline), 1 month, 3 months
Transaminases	Hepatic metabolism: ASAT/ALAT, GGT (unit: UI/l)	0 month (baseline), 1 month, 3 months
Renal metabolism (Urea)	Renal metabolism: Urea (unit: mg/dl)	0 month (baseline), 1 month, 3 months
Renal metabolism (Creatinine Phophoskinase)	Renal metabolism: CPK (unit : UI/l)	0 month (baseline), 1 month, 3 months
Renal metabolism (Lactate Deshydrogenase)	Renal metabolism: LDH (unit : UI/l)	0 month (baseline), 1 month, 3 months

Collaborators and Investigators

• Sponsor: Institut Pasteur de Lille
• Investigators: Principal Investigator: Frédéric Batteux, MD, Institut Pasteur de Lille

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2025
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: March 11, 2025
• First Submitted That Met QC Criteria: March 18, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 18, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Prevention; Hypercholesterolemia; Food supplement
• Additional Relevant MeSH Terms: Metabolic Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Hypercholesterolemia
• Other Study ID Numbers: 2024-A01916-41

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No