DRKS00010789已完成未知
Investigation of anti-inflammatory and anti-oxidative properties of curcumin in overweight subjects: a randomized, double-blind, placebo-controlled study - BTS965/16
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 61
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 70 Years（—）
- 性别
- All
入选标准
- •Age: between 35 and 70 years
- •Overweight and obese men and women
- •Subjects having a body mass index (BMI) between 28 and 40 kg/m²
- •Body fat: Women: = 36%, Men = 23% (assessed with BIA)
- •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 for the duration of the study
- •Subject is in good physical and mental health as established by medical history, physical exami-nation, electrocardiogram, vital signs.
- •Have clinically normal findings for haematology and clinical chemistry (or clinically insignificant, if value is outside of the normal range)
排除标准
- •History or presence of significant cardiovascular disease or co-morbidities (e.g., stroke, diabetes etc.)
- •Known allergy to ingredients of study preparation
- •Present or recent use of drugs and dietary supplements with anti-inflammatory properties that could interfere with the study 2 months before or during the study (e.g. Curcumin, omega-3 FA, chronic intake of NSAR, ibuprofen, glucocorticoids (except inhalative) etc.), vitamin use (e.g. vi-tamin C, vitamin E) or further antioxidative or mineral supplements (e.g. Mg, Ca, OPC etc.).
- •Chronic intake of lipid/glucose modifying agents (e.g. statines, phytosterines, metformin, insulin)
- •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 proton pump inhibitors
- •Chronic intake of substances affecting blood coagulation (e.g. acetylic 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 of human immunodeficiency virus (HIV) or hepatitis B or C
研究者
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