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 range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Evolution over time (from 0 to 3 months) of the plasma concentration of LDL cholesterol

Timeframe: To baseline at 3 months

Trial details

NCT IDNCT06894251

SponsorInstitut Pasteur de Lille

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-30

Contact for this trial

Coralie Berthier, PhD

3 20 87 73 33 coralie.berthier@pasteur-lille.fr

View on ClinicalTrials.gov More Healthy Volunteer trials

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.