Effects of Xylooligosarcharide on Composition of the Human Colonic Microflora
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- The Effects of Xyloologosarcharide (XOS) on colonic bifidobacteria counts in healthy volunteers.
研究概览
简要总结
Human and animal studies demonstrate that xylooligosaccharides (XOS) are a highly efficacious prebiotic ingredient that delivers benefits at a minimum level of 1.4 g/day (d), which is much lower than levels required by fructooligosaccharides (FOS, 5 g/d) or galactooligosaccharides (GOS, 8 g/d). XOS promotes gastrointestinal regularity and relieves diarrhea and constipation at 0.7 g/d and 1.4 g/d, respectively. Xylooligosaccharides may also reduce blood cholesterol and may improve glycemic control, although more data from clinical trials are needed to confirm preliminary findings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 20-50 years of age at screen.
- •In generally good health
- •Subjects must read and sign the Institutional Review Board-approved written informed consent prior to the initiation of any study specific procedures or enrollment. A subject will be excluded for any condition that might compromise the ability to give truly informed consent.
排除标准
- •Any history of gastrointestinal disease except for appendectomy
- •No antibiotic, pre- or probiotic or laxative use during the 2 months before the study.
- •Any subject with a history of diabetes mellitus, or other serious medical condition, such as chronic hepatic or renal disease, bleeding disorder, congestive heart disease, chronic diarrhea disorders, myocardial infarction, coronary artery bypass graft, angioplasty within 6 months prior to screening, current diagnosis of uncontrolled hypertension (defined as systolic BP>160mmHg, diastolic BP>95mmHg), active or chronic gastrointestinal disorders, bulimia, anorexia, or endocrine diseases (except thyroid disease requiring medication) as indicated by medical history or routine physical examination.
- •Any subject with a screening laboratory value outside of the laboratory normal range that is considered clinically significant for study participation by the investigator.
- •Any subject who currently uses tobacco products.
- •Any subject who is pregnant or lactating, or becomes pregnant during the study.
- •Any subject who is unable or unwilling to comply with the study protocol.
研究组 & 干预措施
Xylooligosarcharide 2.8g
Xylooligosarcharide 2.8grams
干预措施: Xylooligosarcharide 2.8g (Dietary Supplement)
Xylooligosarcharide 1.4g
干预措施: Xylooligosarcharide 1.4g (Dietary Supplement)
Sugar Pill
干预措施: Placebo (Maltodextrin) (Dietary Supplement)
结局指标
主要结局
The Effects of Xyloologosarcharide (XOS) on colonic bifidobacteria counts in healthy volunteers.
时间窗: 10 weeks
After a 2 weeks of run-in, 30 healthy volunteers were randomly assigned to take 1.4 grams/day of XOS, or 2.8 grams/day or placebo for 8 weeks. The bifidobarteria counts was assessed at screening, baseline, 4, 8 weeks on supplementation of XOS and after 2 week cessation of XOS.
次要结局
- Tolerance of XOS by healthy volunteers(10 weeks)