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临床试验/NCT04625881
NCT04625881Unknown3 期

Effects of an Apple Derived Fibre Supplement on Digestive Symptoms and Evacuation Frequency in People With Constipation

University of Chile1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年10月1日最近更新:
适应症
干预措施

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

Placebo Comparator

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

Active Comparator

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

发起方
University of Chile
申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniel Bunout

Full professor

University of Chile

研究点 (1)

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