Status:
RECRUITING
Effect of LIMICOL®-NG on Plasma LDL-cholesterol Concentration in Subjects with Moderate Hypercholesterolemia
Lead Sponsor:
Institut Pasteur de Lille
Conditions:
Healthy Volunteer
Eligibility:
All Genders
18-70 years
Phase:
NA
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 consumpt...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT06894251
Start Date
March 10 2025
End Date
December 1 2025
Last Update
March 25 2025
Active Locations (1)
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1
NutrInvest - Institut Pasteur de Lille
Lille, Nord, France, 59019