DRKS00023304已完成未知
A proof of concept study to evaluate the impact of a food supplement on uptake and anti-inflammatory properties of omega-3 fatty acid derived specialized pro-resolution lipid mediators - BTS1487/20
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 19
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
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 35 Years 至 60 Years（—）
- 性别
- Female
入选标准
- •BMI 25-35,
- •Omega-3 Index < 6%,
- •Non-smoker
排除标准
- •(1) Relevant history or presence of any severe medical disorder, potentially interfering with this study (e.g. mal absorption, chronic gastro-intestinal diseases, heavy depression, diabetes, acute cancers within last 3 years except basal cell carcinoma of the skin, etc.)
- •(2) Subject under prescription for medication or taking dietary supplements possibly interfering with this study (such as omega-3 fatty acids, probiotics, anti-spasmodic, laxatives and anti-diarrheic drugs or other digestive auxiliaries, use of PPIs, bismuth salts and/or H2-antagonists, fibers etc.) within 2 weeks prior to study start or during the study
- •(3) Intake of antibiotics in the last 2 months and laxatives in the last 2 weeks
- •(4) Significant changes in lifestyle or medication (within last 2 months) or surgical intervention or surgical procedure such as bariatric surgery
- •(5) Subjects consuming
- •food or drinks claimed as ‘probiotic’ more than once weekly
- •more than 3 portions of fruits and vegetables (sum) per day
- •(6) Subjects with stool frequency of = 2 stools per week
- •(7) Subjects with history of drug, alcohol or other substance abuse, or other factors limiting their ability to co-operate during the study.
- •(8) Relevant allergy or known hypersensitivity against compounds of the study preparations
- •(9) Participation in another clinical study within the last 4 weeks and concurrent participation in another clinical study
- •(10) Anticipating any planned changes in lifestyle or physical activity levels for the duration of the study
- •(11) Not willing to abstain on fish consumption or foods / oils high in omga-3 fatty acids, e.g. linseed oil etc.
- •(12) Known pregnancy, breastfeeding or intention to become pregnant during the study. A pregnancy test will be conducted during screening and visits 1 and 5.
- •(13) 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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