Effect of LIMICOL®-NG on Plasma LDL-cholesterol Concentration in Subjects with Moderate Hypercholesterolemia

Korábbi kezelés

• Subjects receiving hypolipidemic or anti-dyslipidemic treatment (statin, ezetimibe, cholestyramine, fibrate, etc.)
• Subject requiring immediate treatment with statin
• Diabetic subjects treated or not with medication
• 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.

Más betegség

• 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)

Egyéb

• Subjects presenting triglyceridemia > 4g/L (Friedewald)
• Subject requiring immediate dietary intervention or having fluctuating eating behavior
• 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)
• Pregnant woman or planning to become pregnant during the study period or breastfeeding

• 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.