NCT06894251 Effect of LIMICOL®-NG on Plasma LDL-cholesterol Concentration in Subjects with Moderate Hypercholesterolemia
| NCT ID | NCT06894251 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institut Pasteur de Lille |
| Condition | Healthy Volunteer |
| Study Type | INTERVENTIONAL |
| Enrollment | 35 participants |
| Start Date | 2025-03-10 |
| Primary Completion | 2025-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 35 participants in total. It began in 2025-03-10 with a primary completion date of 2025-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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.
Contact & Investigator
Frédéric Batteux, MD
PRINCIPAL INVESTIGATOR
Institut Pasteur de Lille
Frequently Asked Questions
Who can join the NCT06894251 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Healthy Volunteer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06894251 currently recruiting?
Yes, NCT06894251 is actively recruiting participants. Contact the research team at coralie.berthier@pasteur-lille.fr for enrollment information.
Where is the NCT06894251 trial being conducted?
This trial is being conducted at Lille, France.
Who is sponsoring the NCT06894251 clinical trial?
NCT06894251 is sponsored by Institut Pasteur de Lille. The principal investigator is Frédéric Batteux, MD at Institut Pasteur de Lille. The trial plans to enroll 35 participants.