Effect of LIMICOL®-NG on LDL cholesterol levels in people with moderate high cholesterol
Effect of LIMICOL®-NG on Plasma LDL-cholesterol Concentration in Subjects with Moderate Hypercholesterolemia
This study tests if taking the LIMICOL®-NG supplement can lower LDL cholesterol levels in people with moderately high cholesterol over three months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Institut Pasteur de Lille Academic / other |
| Locations | 1 site (Lille, Nord) |
| Trial ID | NCT06894251 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the impact of the LIMICOL®-NG food supplement on lowering plasma LDL cholesterol levels in individuals with untreated moderate hypercholesterolemia over a period of three months. Participants will consume the supplement and undergo assessments at baseline, one month, and three months to monitor changes in various health parameters, including cholesterol levels, weight, and blood pressure. The results will be compared to historical data from a placebo group to determine the effectiveness of the supplement.
Who should consider this trial
Good fit: Ideal candidates for this study are pre-menopausal or menopausal women with untreated LDL cholesterol levels above 1.3 g/L and stable lifestyle habits.
Not a fit: Patients currently on hypolipidemic treatments or with significantly elevated triglyceride levels will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new dietary approach to managing cholesterol levels in individuals with moderate hypercholesterolemia.
How similar studies have performed: While there have been studies on dietary supplements for cholesterol management, the specific approach of LIMICOL®-NG in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Lille, Nord
- NutrInvest - Institut Pasteur de Lille — Lille, Nord, France (Recruiting)
Study contacts
- Principal investigator: Frédéric Batteux, MD — Institut Pasteur de Lille
- Study coordinator: Coralie Berthier, PhD
- Email: coralie.berthier@pasteur-lille.fr
- Phone: 3 20 87 73 33
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.