Effects of an Apple Derived Fibre Supplement on Constipation

Phase 3

• Conditions: Functional Gastrointestinal Disorders; Constipation
• Interventions: Dietary Supplement: Apple derived fiber

• Registration Number: NCT04625881
• Lead Sponsor: University of Chile

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2020-10-01
• Status Verified: 2020-11
• Study First Submitted: 2020-11-06
• Study First Submitted QC: 2020-11-06
• Last Update Submitted: 2020-11-06
• Study First Posted: 2020-11-12
• Last Update Posted: 2020-11-12
• Primary Completion: 2021-01-10
• Study Completion: 2021-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• presence of constipation or functional gastrointestinal symptoms

Exclusion Criteria

having serious cardiovascular, kidney or hepatic diseases

• gastrointestinal bleeding weight loss use of laxatives use of medications with anticholinergic actions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active product	Apple derived fiber	A powder containing 20 g of apple derived fiber will be consumed daily
Placebo	Apple derived fiber	A rice derived placebo devoid of fiber and aromatized with apple fragancy will be provided

Primary Outcome Measures

Name	Time	Method
Gastrointestinal symptom rating scale	every 2 weeks during 8 weeks	This scale assesses abdominal pain, bloating and type of stools

Secondary Outcome Measures

Name	Time	Method
Number of complete spontaneous bowel movements per week	every 2 weeks during 8 weeks	the title is auto-explicative

Trial Locations

Locations (1)

Institute of Nutrition and Food Technology University of Chile; 🇨🇱 Santiago, Metropolitana, Chile