Effect of LIMICOL®-NG on Plasma LDL-cholesterol Concentration in Subjects with Moderate Hyperchol… (NCT06894251) | Clinical Trial Compass
RecruitingNot Applicable
Effect of LIMICOL®-NG on Plasma LDL-cholesterol Concentration in Subjects with Moderate Hypercholesterolemia
France35 participantsStarted 2025-03-10
Plain-language 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
Who can participate
Age range18 Years – 70 Years
SexALL
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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 lev…
What they're measuring
1
Evolution over time (from 0 to 3 months) of the plasma concentration of LDL cholesterol