Effect of food supplements with artichoke leaf extract and lactobacilli on LDL-cholesterol levels in subjects with LDL hypercholesterolemia - Alac

Institut für Lebensmittelwissenschaft und Humanernährung0 个研究点目标入组 180 人开始时间: 2020年1月7日最近更新: 2024年8月19日

适应症

试验速览

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•LDL-cholesterol concentration = 4.1 mmol/l that are not intended for statin treatment; or reject it,
•written consent of the subjects after detailed oral and written information on the study contents, requirements and risks,
•ability and willingness of the study participants to follow the instructions of the investigator (compliance with the study conditions, use of the test products according to the dosage recommendation, etc.),
•willingness to take part on the whole study procedure

•LDL-cholesterol <160mg/dl or = 220mg/dl, Triglycerides = 220mg/dl, BMI >35 kg/m2, intake of lipid and especially cholesterol-lowering drugs (e.g., statins, fibrates, bile acid exchange resins, phytosterols, ezetimibe) within the last three months before the planned start of the intervention,
•use of dietary supplements that affect the lipid- and cholesterol levels (omega-3 fatty acids, phytosterols, polyglucosamine or other lipid adsorbing substances) four weeks before and during the study, severe chronic diseases (tumor, diabetes type 1, etc.), manifest cardiovascular diseases (e.g. angina pectoris, heart failure), renal insufficiency, liver disease, intake of immunosuppressives or chronic corticosteroids, known allergy or intolerance to artichokes or other ingredients contained in the preparation, chronic diseases of the gastrointestinal tract (ulcerative colitis, Crohn's disease, pancreatic insufficiency), surgery of the heart (stent, bypass, pacemaker) or digestive tract (exceptions: removal of cecum or gallbladder), regular intake of laxatives, imminent surgical procedures, alcohol, drug and/or medicines addiction, intake of antibiotics three months before study begin (for those participants who collect a fecal sample), persons unable to give consent

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