Prebiotic effect of Inulin-type fructans
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 64
研究概览
简要总结
Inulin and oligofructose are prebiotic dietary fibers which affect gut microbiota and thereby host health. We aimed to demonstrate that 2.5 g/d oligofructose can lead to a significant increase in bifidobacteria thereby contributing to host health. 64 volunteers were randomized to consume 2.5 g/d Orafti® oligofructose or placebo for 14 days followed by a 4 week wash-out period and then crossed-over to the other intervention. Bifidobacteria and affect were assessed at the beginning and end of each intervention period. Furthermore, digestive function was documented daily. Bifidobacterium spp. increased significantly upon 2.5 g/d oligofructose intake compared to placebo (p = 0.016). Furthermore, stool frequency significantly increased during oligofructose compared to placebo (p = 0.0204) intake. With respect to affect, no significant changes were observed. This study is the first to demonstrate a significant increase in bifidobacteria coinciding with increased stool frequency after a very low dose of 2.5 g/d chicory oligofructose.
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 65 Years（—）
- 性别
- Male
入选标准
- •Subject is in good physical and mental health as established by medical history and physical examination
- •Men with typical Western style eating Patterns
- •Age: 18-65 years
- •BMI =18.5 and =35 kg/m²
- •Nonsmoker and moderate smokers (maximal 10 cigarettes/day)
- •Written informed consent to participate in the study
- •Able and willing to follow the study protocol procedures
排除标准
- •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.)
- •Subject under prescription for medication for digestive symptoms such as anti-spasmodic, laxatives and anti-diarrheic drugs or other digestive auxiliaries, use of PPIs, bismuth salts and/or H2-antagonists
- •Significant changes in lifestyle or medication (within last 3 mo.) or surgical intervention or surgical procedure such as bariatric surgery
- •Vegetarians, vegans
- •Subjects who consume
- •- Food or drinks claimed as ‘probiotic’, or ‘prebiotic’ more than once per week
- •- Food or drinks claimed as ‘rich in fiber’ (including specific milk products) more than 3 times per week
- •- More than 3 portions of fruits and vegetables per day (e.g. 2 portions of fruit and 1 portion of vegetables or 1 portion of fruit and 2 portions of vegetables)
- •Subjects with stool frequency of = 2 stool every 7 days
- •Subjects not willing to avoid pre- and probiotics for the duration of the study
- •Regular intake of drugs or dietary supplements possibly interfering with this study (e.g. antispasmodics, laxatives, fibers, etc.) within 2 weeks prior to study start or during study
- •Subjects with history of drug, alcohol or other substance abuse, or other factors limiting their ability to co-operate during the study
- •Intake of antibiotics in the last 2 months and laxatives in the last 2 weeks
- •Known Food intolerance or allergy