Clinical trial NCT06894251: Effect of LIMICOL®-NG on Plasma LDL-cholesterol Concentration in Subjects with Moderate Hypercholesterolemia
Official title: Effect of LIMICOL®-NG on Plasma LDL-cholesterol Concentration in Subjects with Moderate Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Volunteer
Keywords: Prevention
Food supplement
Hypercholesterolemia
Lead sponsor: Institut Pasteur de Lille
Sponsor class: OTHER
First posted: 2025-03-25
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Group receiving the food supplement
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Evolution over time (from 0 to 3 months) of the plasma concentration of LDL cholesterol
timeFrame: To baseline at 3 months
Secondary outcomes:
measure: Weight
timeFrame: 0 month (baseline), 1 month, 3 months
measure: Body Mass Index
timeFrame: 0 month (baseline), 1 month, 3 months
measure: Waist circumference
timeFrame: 0 month (baseline), 1 month, 3 months
measure: Blood pressure
timeFrame: 0 month (baseline), 1 month, 3 months
measure: Heart rate
timeFrame: 0 month (baseline), 1 month, 3 months
measure: Fasting glycemia
timeFrame: 0 month (baseline), 1 month, 3 months
measure: Lipid metabolism
timeFrame: 0 month (baseline), 1 month, 3 months
measure: Hepatic metabolism
timeFrame: 0 month (baseline), 1 month, 3 months
measure: Transaminases
timeFrame: 0 month (baseline), 1 month, 3 months
measure: Renal metabolism (Urea)
timeFrame: 0 month (baseline), 1 month, 3 months
measure: Renal metabolism (Creatinine Phophoskinase)
timeFrame: 0 month (baseline), 1 month, 3 months
measure: Renal metabolism (Lactate Deshydrogenase)
timeFrame: 0 month (baseline), 1 month, 3 months
Other outcomes:
Locations:
city: Lille
country: France
facility: NutrInvest - Institut Pasteur de Lille
state: Nord
Study officials:
affiliation: Institut Pasteur de Lille
name: Frédéric Batteux, MD
role: PRINCIPAL_INVESTIGATOR
References: