DRKS00030572招募中2 期
Effect of sugar beet pectin on bowel habit and gut microbiota in healthy adults with hard stools: a randomized, double-blind, placebo controlled trial - UltraPulp
Cosun Beet Company0 个研究点目标入组 40 人开始时间: 2023年1月6日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
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 80 Years（—）
- 性别
- All
入选标准
- •Healthy subjects
- •- Hard stools defined by Bristol Stool Form Scale (category 1 to =2)
- •- Omnivore diet
- •- Age: 18 - 80 years
- •- All genders
- •- BMI (kg/m²): 18,5 - 34.9
- •- non-Smoker
排除标准
- •- Subjects with stool consistency =3 (Bristol Stool Form Scale)
- •- Presence of acute/ chronic diseases
- •- Clinical diagnosed diseases with relevant effect on the gastrointestinal system or on visceral motility, such as: coeliac disease, inflammatory bowel disease (Crohn's disease, ulcerative colitis), irritable bowel disease diagnosed according to Rome III criteria with diarrhea-predominant type, irritable bowel syndrome diagnosed according to Rome IV criteria (highest level according to IBS-SSS), relevant bowel resections including short bowel syndrome
- •- Relevant history, presence of any medical disorder or chronic intake of medication/dietary supplements potentially interfering with this trial
- •- Regular intake of prebiotics or products claimed as prebiotic”, probiotic”, dietary fibres supplements and laxatives (medicinal drugs to promote intestinal transit) during the study
- •- Vegan, vegetarian diet
- •- Strongly atypical or restrictive diets/concepts followed voluntarily (macrobiotics, paleo diet, Atkins diet, Mayo diet, Insticto diet) or due to food intolerances/food allergies
- •- Average daily alcohol consumption > 10 g for women and > 20 g for men, consideration of alcohol abuse
- •- Athletes (extensive physical activity)
- •- Current use of antibiotics
- •- Willingness to discontinue laxatives approved as medicines
- •- Simultaneous participation in other studies that are associated with drug use and have a potentially significant impact on body composition or dietary behaviour
- •- Lactation, pregnancy, planned pregnancies that interfere with the study period
研究者
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