Effects of an Apple Derived Fibre Supplement on Constipation

Last updated: November 6, 2020
Sponsor: University of Chile
Overall Status: Active - Recruiting

Phase

3

Condition

Constipation

Ulcers

Bowel Dysfunction

Treatment

N/A

Clinical Study ID

NCT04625881
Manzana
  • Ages 20-70
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • presence of constipation or functional gastrointestinal symptoms

Exclusion

Exclusion Criteria: having serious cardiovascular, kidney or hepatic diseases

  • gastrointestinal bleeding weight loss use of laxatives use of medications withanticholinergic actions

Study Design

Total Participants: 60
Study Start date:
October 01, 2020
Estimated Completion Date:
January 31, 2021

Study 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

Connect with a study center

  • Institute of Nutrition and Food Technology University of Chile

    Santiago, Metropolitana
    Chile

    Active - Recruiting

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