Opportunities for Increasing Consumption of Local Fruits and Vegetables in Slovenian Population (NutriPlant)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in frequency of complete spontaneous bowel movements (CSBM) / week
研究概览
简要总结
The effects of different foods to normal bowel function in adult population will be investigated. A randomised controlled intervention trial will be conducted on about 120 (30 per group) adult (18-70 years) subjects with functional constipation and irritable bowel syndrome with constipation according to the IV. Rome criteria. At least one week before inclusion in the study, patients will stop taking laxatives and other anti-constipation medications. Subjects will be randomly selected to consume one of the test foods (fresh apples, dried apples, sauerkraut) or the active control (psyllium) in the equivalent amount of 3 g of fiber per day for 4 weeks. Subjects will be asked not to change their lifestyle habits, such as diet and physical activity level, and not to take oral laxatives during the period of participation in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Intervention include consumption of specific foods, therefore masking to participant and investigatior is not possible. Collected data will be masked for accessor of outcomes.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria:
- •Signed informed consent of the participant to participate in the study
- •Age between 18 and 70 years
- •Functional constipation or irritable bowel syndrome
- •Expressed willingness to eat the investigated food daily (sauerkraut, apples, dried apples or psyllium; period of four weeks)
排除标准
- •Known allergy to the investigated foods (fresh apples, dried apples, sauerkraut or psyllium)
- •Pregnancy or breastfeeding
- •Previous gastrointestinal surgery with the exception of cholecystectomy and appendectomy
- •Other gastrointestinal diseases (chronic inflammatory bowel disease, celiac disease, gastroparesis, etc.)
- •Serious chronic diseases
- •Introduction of extensive changes in diet or physical activity in the last 4 weeks before the inclusion examination
- •Regular use of laxatives or inability to stop using laxatives for the duration of the study
- •Concurrent participation in another study
研究组 & 干预措施
Dried apples
Dried apples containing 3 g dietary fibre, daily, for 4 weeks
干预措施: Dried apples (Other)
Sauerkraut
Sauerkraut containing 3 g dietary fibre, daily, for 4 weeks
干预措施: Sauerkraut (Other)
Fresh apples
Fresh apples containing 3 g dietary fibre, daily, for 4 weeks
干预措施: Fresh apples (Other)
Psyllium
Psyllium containing 3 g dietary fibre, daily, for 4 weeks
干预措施: Psyllium (Other)
结局指标
主要结局
Change in frequency of complete spontaneous bowel movements (CSBM) / week
时间窗: fourth week vs pre-intervention
Daily measurement of number of complete spontaneous bowel movements
次要结局
未报告次要终点