DRKS00015251已完成未知
Clinical study to investigate lipid modifying effects of hydroxytyrosol – a randomized, double-blind, placebo-controlled parallel study - BTS1214/18
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 92
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •Subject is able and willing to sign the Informed Consent Form prior to screening Evaluations;
- •Sex: male and female (at least 30% of each gender);
- •BMI: 18.5 – 35 kg/m²;
- •Adults at total CV risk score < 5 % (SCORE-Germany, moderate risk);
- •At screening LDL-cholesterol =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
排除标准
- •Relevant history or presence of any medical disorder potentially interfering with this study
- •(heavy depression, diabetes, active cancer, liver disease, heavy cardiovascular diseases (e.g.
- •stroke, heart attack); Chronic intake of medication/dietary supplements (e.g. medical lipid reducing therapy according to cardiologic guidelines, phytosterols, red yeast rice, garlic, omega-3 fatty acids etc.) potentially interfering with this study during the last 2 months before screening or during the study; stable doses of e.g. hypertensive therapy and thyroid gland hormones are acceptable.
- •Consumption of a fatty fish and/or seafood meals is greater than twice per month during intervention and 4 weeks prior study start; Fasting triglyceride levels > 350 mg/dl; Extreme dietary regimes”: vegan lifestyle, weight loss diet with <1200 kcal/day for women and <1800 kcal/day for men; Weight loss intervention or recent body weight change > 4.5 kg; 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: 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
研究者
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