NCT04625881

Effects of an Apple Derived Fibre Supplement on Constipation

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Chile · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• Constipation
• Functional Gastrointestinal Disorders

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Apple derived fiber	This is a combination of soluble and insoluble fiber

Timeline

• Start date: 2020-10-01
• Primary completion: 2021-01-10
• Completion: 2021-01-31
• First posted: 2020-11-12
• Last updated: 2020-11-12

Locations

1 site across 1 country: Chile