DRKS00030106已完成未知
Formation and uptake of specialized pro-resolving lipid mediators from a synbiotic, omega-3 fatty-acid food supplement: a double-blind, randomized, placebo-controlled parallel design with healthy subjects
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 72
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
- 30 Years 至 75 Years（—）
- 性别
- All
入选标准
- •(1) Women and men with low habitual consumption of fatty fish and seafood, defined as a frequency of twice per month or less (minimum 25% of each gender)
- •(2) BMI: 19-35 kg/m²
- •(3) Omega-3 index in erythrocytes: = 6.0 % at screening
- •(4) Classification as at-risk individual” according to AGE (advanced glycation end products) reader
- •(5) hsCRP level = 1 mg/L at screening visit
- •(6) Non-smoker
- •(7) Subject is in good physical and mental health as established by medical history, physical examination, vital signs, results of biochemistry, haematology
- •(8) Written consent to participate in the study
- •(9) Able and willing to follow the study procedures
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, chronic intake of NSAR or acetylsalicylic acid, glucocorticoids 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) Vegans
- •(6) Subjects consuming
- •food or drinks claimed as ‘probiotic’ more than once weekly
- •(7) Subjects with stool frequency of = 2 stools per week
- •(8) Subjects with history of drug, alcohol or other substance abuse, or other factors limiting their ability to co-operate during the study
- •(9) Relevant allergy or known hypersensitivity against compounds of the study preparations (e.g. fish)
- •(10) Participation in another clinical study within the last 4 weeks and concurrent participation in another clinical study
- •(11) Anticipating any planned changes in lifestyle or physical activity levels for the duration of the study
- •(12) Not willing to abstain on fish consumption or foods / oils high in omega-3 fatty acids, e.g. linseed oil etc.
- •(13) If female: currently pregnant, planning to become pregnant during the study period, breastfeeding (a pregnancy test will be conducted during screening and visits 1 and 3)
- •(14) 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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