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

Not Applicable

Recruiting

• Conditions: Healthy Volunteer

• Registration Number: NCT06894251
• Lead Sponsor: Institut Pasteur de Lille

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.

Study Timeline

• Status Verified: 2025-03
• Study Start: 2025-03-10
• Study First Submitted: 2025-03-11
• Study First Submitted QC: 2025-03-18
• Last Update Submitted: 2025-03-18
• Study First Posted: 2025-03-25
• Last Update Posted: 2025-03-25
• Primary Completion: 2025-09-30
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 35

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Evolution over time (from 0 to 3 months) of the plasma concentration of LDL cholesterol	To baseline at 3 months	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 %).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

NutrInvest - Institut Pasteur de Lille; 🇫🇷 Lille, Nord, France