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

Launched by INSTITUT PASTEUR DE LILLE · Mar 18, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a food supplement called LIMICOL®-NG on lowering LDL cholesterol, which is often referred to as "bad" cholesterol, in people with moderately high cholesterol levels. The main goal is to see if taking this supplement for three months can reduce LDL cholesterol levels by at least 10%. This trial is currently looking for healthy volunteers aged 65 to 75, regardless of gender, who have a specific level of LDL cholesterol and have maintained stable eating and exercise habits for at least three months.

To participate, women must either use effective birth control if they are pre-menopausal or not be using hormone replacement therapy if they are post-menopausal. Participants should not be on any cholesterol-lowering medications or have certain health conditions that could interfere with the study. Those who join can expect to take the supplement daily and follow some guidelines to ensure the study's success. It's important to know that participants will need to sign consent forms and maintain their usual lifestyle throughout the trial.

Gender

ALL

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.