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

Pasteur Institute of Lille (IPL)

Status: Enrolling

Conditions: Healthy Volunteer

Treatments: Dietary Supplement: LIMICOL® NG

Study type: Interventional

Funder types: Other

Identifiers

NCT06894251

2024-A01916-41

Details and patient eligibility

About

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

Full 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.

Enrollment: 35 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Food supplement group

Experimental group

Description:

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

Treatment:

Dietary Supplement: LIMICOL® NG