Phase
Condition
Hypercholesterolemia
Treatment
LIMICOL® NG
Clinical Study ID
Ages 18-70 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
For women
If pre-menopausal: effective non-estrogenic contraception established for atleast 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
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 eatingbehavior
Diabetic subjects treated or not with medication
Subjects with unstable treatment (for less than three months), or requiring theimplementation 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 kidneyfunction)
Subjects who have consumed in the last 3 months food supplements or functional foodsthat could impact cholesterol or TG levels (phytosterol, phytostanol, red yeastrice, policosanols, beta-glucans at a dose greater than 3 g/day, probiotics)
Subjects suffering from a severe chronic condition deemed incompatible with thestudy by the investigator (serious digestive pathologies, renal failure, coronarypathology, immunodeficiency, heart failure, rhythm disorders, progressive tumorpathology, blood disease)
Subject suffering from a severe eating disorder (anorexia, bulimia, binge eatingdisorder)
Pregnant woman or planning to become pregnant during the study period orbreastfeeding
Whose state of health or concomitant treatments are judged by the principalinvestigator or a qualified co-investigator to be incompatible with the properconduct of the clinical study.
Study Design
Study Description
Connect with a study center
NutrInvest - Institut Pasteur de Lille
Lille, Nord 59019
FranceActive - Recruiting

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