NCT01002651已完成不适用
In Vivo Evaluation of the Physiological Effects of Arabinoxylan-oligosaccharides (AXOS) in Healthy Subjects: a Randomized, Placebo-controlled, Double-blind, Cross-over Study
Fugeia NV2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2009年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Bifidobacteria content in feces
研究概览
简要总结
The investigational study product used in this clinical trial is a soft drink containing an arabinoxylan-oligosaccharides (AXOS) preparation extracted from wheat bran (hereafter called Wheat Bran Extract, WBE).
The objective of this study is to analyze the effect of the intake of two WBE doses on various parameters of gastrointestinal health. Additionally, safety was analyzed using treatment emergent Adverse Events (AEs) and clinical blood parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female 18-90 years of age, inclusive
- •Regular eating habits
- •Body Mass Index (BMI) between 18.5 and 30 kg/m2
- •Consent to take in the study product according to the study protocol
- •Subject is willing to maintain his or her habitual food and beverage intake throughout the study period (with the exception of omission of prebiotic and probiotic food products as indicated in the study protocol)
- •For female volunteers of childbearing potential: not planning to become pregnant during the clinical trial and willing to commit to the use of a medically approved form of contraception
排除标准
- •Low-calorie diet or other extreme dietary habits in the 6 weeks before the start of the clinical trial
- •Recent use of antibiotics
- •Abdominal surgery in the past
- •Serious illness within 3 months of start of clinical trial
- •Use of medication or dietary supplements known to influence GI tract within two weeks of start of clinical trial. Examples of such medication/dietary supplements are antispasmodics, anti diarrhea medication and/or probiotic medication
- •Complete anesthetics within 1 month of the start of the clinical trial
- •Chronic GI conditions such as inflammatory bowel disease (IBD), inflammatory bowel syndrome (IBS), chronic constipation, history of frequent diarrhea, clinically important lactose intolerance
- •Allergy for wheat products
- •Celiac disease
- •For female volunteers: pregnant or lactating
- •Alcohol abuse
- •Smoking more than 5 cigarettes per day
- •Subject has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the subject at undue risk.
结局指标
主要结局
Bifidobacteria content in feces
时间窗: day 19 or 20 of each intervention
butyric acid content in feces
时间窗: day 19 or 20 of each intervention
p-cresol content in urine
时间窗: day 19-21 of each intervention
stool frequency
时间窗: third week of each intervention
次要结局
- adverse events(whole study)
- clinical blood parameters(day 21 of each intervention)
研究者
研究点 (2)
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