Clinical study to investigate lipid-modifying effects of a Saskatoon berry extract - a randomized, double-blind, placebo-controlled parallel study - BTS1212/18

Prairie Berries Europe GmbH0 个研究点目标入组 50 人开始时间: 2018年9月6日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Age: 18-75 years
•BMI: 18.5-35 kg/m²
•Adults at total CV risk score <1 % (low risk (SCORE-Germany)) and LDL-C levels >160 and <190 mg/dL
•Adults at total CV risk score =1 % and <5 % (moderate risk (SCORE-Germany)) and LDL-C levels =115 and <190 mg/dL
•Subject is in good physical and mental health as established by medical history, physical examination, electrocardiogram, vital signs, results of biochemistry, haematology

•Medication to lower serum lipids
•Serum fasting TG > 500 mg/dL
•History of cardiovascular disease
•Chronic diseases (e.g. diabetes, cancer, liver disease etc)
•Consumption of any dietary supplement /fortified food known to influence cholesterol levels
•Weight loss intervention or recent boy weight change >4.5 kg
•Diet high in vegetables and fruits = 5 portions per day
•Vegan lifestyle
•Smoker > 10 cigarettes / day
•Gastrointestinal diseases/conditions (colitis ulcerosa, Crohn’s disease, peptic ulcers, celiac disease)
•Drug-, alcohol- and medication abuses
•Known HIV-infection
•Known acute or chronic hepatitis B and C infection
•Relevant allergy or known hypersensitivity against compounds of the study preparations
•Women: known pregnancy, breast feeding or intention to become pregnant during the study
•Participation in another clinical study within the last 4 weeks and concurrent participation in another clinical study
•Blood donation within 4 weeks prior study start (screening) or during study.
•Anticipating any planned changes in lifestyle for the duration of the study
•Subjects considered inappropriate for the study by investigators, including subjects who are unable or unwilling to show compliance with the protocol

发起方

Prairie Berries Europe GmbH