DRKS00022855已完成未知
Intervention study to investigate effects of VITACEL® extrinsic wheat fibers incorporated in food products for maintenance of normal defecation by increase of fecal bulk in healthy subjects
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 31
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
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •Subject is in good physical and mental health
- •Average fiber intake = 20 g/ day (during run-in phase)
- •-Stool frequency: 2 - 5 bowel movements per week
- •-BMI between 19.0 and 30.0 kg/m2
- •-Non-smoker
- •-Written consent to participate in the study
- •-Able and willing to follow the study procedures
排除标准
- •-Relevant history or presence of any severe medical disorder, potentially interfering with this study in the investigator’s judgement
- •-Subject under prescription for medication or taking dietary supplements possibly interfering with this study within 2 weeks prior to study start or during the study (Stable medication (more than 3 months) for hypertension or thyroid gland is allowed)
- •-Intake of antibiotics in the last 3 months prior to screening
- •-Use of pre- and probiotic supplements
- •-Subjects consuming food or drinks claimed as ‘probiotic’, or ‘prebiotic’ more than once weekly
- •-Subjects consuming food or drinks claimed as ‘rich in fiber’ (including specific milk products) more than 3 times per week
- •-Subjects consuming more than 3 portions of fruits and vegetables (sum) per day
- •-Exclusively vegan or vegetarian diet
- •-Regular laxative use at least once per week
- •-Regular stool consistency of diarrheal subtype at least once every two weeks (Bristol stool scale type 5-7)
- •-Subjects with history of drug, alcohol or other substance abuse, or other factors limiting their ability to cooperate during the study
- •-No availability of a freezer with sufficient capacity to store the provided study foods
- •-Known pregnancy, breastfeeding or intention to become pregnant during the study. A pregnancy test will be conducted during screening and visits 1-4.
- •-Subjects with stool frequency of < 2 stools per week
- •-Known allergy to the test products
- •-Change of dietary habits within the 4 weeks prior to screening
- •-Anticipating any planned changes in lifestyle or physical activity levels for the duration of the study
- •-Subject involved in any clinical or food study within the preceding month
- •-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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