DRKS00010859已完成未知
Effects of hydroxytyrosol on protection of LDL particles from oxidative damage: a randomized, double-blind, placebo-controlled cross-over study - BTS964_16
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 30
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
- 35 Years 至 65 Years（—）
- 性别
- All
入选标准
- •Body mass index (BMI) between 19 and 30 kg/m²
- •-Non-smoker
- •- Subject is able and willing to sign the Informed Consent Form prior to screening evaluations
- •- Subject is able to communicate well with the Investigator, to understand and comply with the requirements of the study, and be judged suitable for the study in the opinion of the Investigator
- •- Not anticipating any planned changes in lifestyle regarding activity and nutrition
- •- Subject is in good physical and mental health
- •- Clinically normal findings for haematology and clinical chemistry (or clinically insignificant)
排除标准
- •- Cholesterol >250 mg/dL, LDL-cholesterol >160 mg/dL, triglycerides >150 mg/dL
- •- Significant cardiovascular disease or co-morbidities (e.g. stroke, diabetes)
- •- Known allergy to ingredients of study preparation
- •- Use of drugs and dietary supplements with lipid-modifying and anti-oxidative properties that could interfere with the study 2 months before or during the study (e.g. statines, phytosterines, omega-3 fatty acids, vitamin use (e.g. vitamin C, vitamin E) or further antioxidative supplements (e.g. OPC, curcumin).
- •- Use of hypertensive drugs (e.g. ß-blocker, hypertensiva)
- •- Female patients that are pregnant or nursing
- •- Fat malabsorption (Crohn’s or celiac disease, cystic fibrosis)
- •- Gastrointestinal diseases/conditions (colitis ulcerosa, Crohn’s IBS, IBD, peptic ulcers, celiac, reflux disease)
- •- Gall bladder resection
- •- Chronic intake of substances affecting blood coagulation (e.g. acetylsalicylic acid, anticoagulants, diuretics, thiazides) which in the investigator’s opinion would impact volunteer safety
- •- Donation of blood within the previous 4 weeks before screening
- •- Participation in a clinical trial with an investigational product within 4 weeks before screening
- •- Known alcohol abuse or drug abuse
- •- Known infection with human immunodeficiency virus (HIV) or hepatitis B or
研究者
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