Effects of an Apple Derived Fibre Supplement on Digestive Symptoms and Evacuation Frequency in People With Constipation
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Gastrointestinal symptom rating scale
研究概览
简要总结
We will conduct a 2 months clinical intervention in which a 20 g appled derived fibre supplement will be compared with a placebo without fibre. The main outcome will be the reduction in the Gastrointestinal System Rating Scale
详细描述
Participants with constipation and mild gastrointestinal symptoms will be invited to participate. Those with alarming symptoms such as gastrointestinal bleeding or weight loss, those using laxatives or medications with anticholinergic actions will be excluded from the study At baseline, participants will be weighed and interrogated about Their gastrointestinal symptoms using the "Gastrointestinal symptom rating scale" Their type of stools using the Bristol visual stool scale The number of complete spontaneous bowel movements per week Afterwards, they will be randomized, balancing by age, gender and body mass index to receive in a doubly blind fashion A 20 g/day powder with apple derived fiber A similarly looking placebo powder The intervention will last 8 weeks. Every two weeks, participants will be cited to provide a new supply of the product, retrieve the used vials and be interrogated using the same tools as baseline. At the end of the intervention, participants will be weighed again
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Active product and placebo will have the same appearance. All vials will have an unique numerical code
入排标准
- 年龄范围
- 20 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •presence of constipation or functional gastrointestinal symptoms
排除标准
- •having serious cardiovascular, kidney or hepatic diseases
- •gastrointestinal bleeding weight loss use of laxatives use of medications with anticholinergic actions
研究组 & 干预措施
Placebo
A rice derived placebo devoid of fiber and aromatized with apple fragancy will be provided
干预措施: Apple derived fiber (Dietary Supplement)
Active product
A powder containing 20 g of apple derived fiber will be consumed daily
干预措施: Apple derived fiber (Dietary Supplement)
结局指标
主要结局
Gastrointestinal symptom rating scale
时间窗: every 2 weeks during 8 weeks
This scale assesses abdominal pain, bloating and type of stools
次要结局
- Number of complete spontaneous bowel movements per week(every 2 weeks during 8 weeks)
研究者
Daniel Bunout
Full professor
University of Chile
