DRKS00000589已完成未知

Effect of a dietary supplement with tocotrienols and polymethoxylated flavones (PMF) on serum lipid parameters in probands with hypercholesterolemia and elevated hsCRP levels

eibniz Universtiät HannoverInstitut für Lebensmittelwissenschaft und Humanernährung0 个研究点目标入组 225 人开始时间: 2010年10月20日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Caucasians, LDL-C = 130 mg/dL (= 3.3 mmol/L) and, persisting hsCRP = 2 mg/L, written confirmation of participants after detailed oral and written explanation about the study contents, and - requirements, ability and willingness of the participants to attend the investigator's orders (compliance of the study conditions, consumption of the dietary study supplements according to the dosage recommendation)

•Triglyceride = 400 mg/dL (= 4,5 mmol/L).
•Total Cholesterol = 500 mg/dL (= 13 mmol/L).
•hsCRP = 10 mg/L.
•Body-Mass-Index (BMI) = 35.
•Simultaneous treatment with lipid lowering medication (e. g. Fibrates, bile acid exchanger resin, phytosteroles, Ezetimibe).
•treatment with HMG-CoA-reductase inhibitors (statins) in the last three month.
•Simultaneous consumption of coagulation-inhibiting drugs (for example Marcumar)
•routine consumption of laxative.
•taking any supplements with omega-3 fatty acids, Vitamine E, phytosteroles, polyglucosamines (Chitosan) or other lipid binding ingredients.
•heavy chronic diseases (tumors, diabetes typ 1, etc.), documented coronary heart disease, blood clotting disorders, renal failure, liver diseases.
•chronic inflammatory diseases (e. g. Colitis ulcerosa, Morbus Crohn, rheumatoid arthritis).
•allergy or intolerance to any ingredients of the test products.
•common exclusion criterias like
•opregnancy and lactation
•oalcohol-, drug- and/or medicament dependence
•osubjects who are not in agreement with the study conditions
•orefusial or rather reset of the consent from the subject
•oactive participation in other clinical trial within the last 30 days

发起方

eibniz Universtiät HannoverInstitut für Lebensmittelwissenschaft und Humanernährung