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

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

Study Overview

• Status: Unknown
• Conditions: Constipation; Functional Gastrointestinal Disorders
• Intervention / Treatment: Dietary supplement: Apple derived fiber

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Francisco Perez, Ph D; Phone Number: +56229781411; Email: fperez@inta.uchile.cl
• Study Contact Backup: Name: Rodrigo Troncoso, PhD; Phone Number: +56229781486; Email: rtroncoso@inta.uchile.cl

Study Locations

• Chile
  • Metropolitana
    • Santiago, Metropolitana, Chile
      • Recruiting
      • Institute of Nutrition and Food Technology University of Chile
      • Contact: Veronica Cornejo, MSc; Phone Number: +56229781411; Email: vcornejo@inta.uchile.cl
      • Contact: Patricio Peirano, MD; Phone Number: +562291781411; Email: ppeirano@inta.uchile.cl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Active product; A powder containing 20 g of apple derived fiber will be consumed daily	Dietary supplement: Apple derived fiber; This is a combination of soluble and insoluble fiber
PLACEBO_COMPARATOR: Placebo; A rice derived placebo devoid of fiber and aromatized with apple fragancy will be provided	Dietary supplement: Apple derived fiber; This is a combination of soluble and insoluble fiber

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastrointestinal symptom rating scale	This scale assesses abdominal pain, bloating and type of stools	every 2 weeks during 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of complete spontaneous bowel movements per week	the title is auto-explicative	every 2 weeks during 8 weeks

Collaborators and Investigators

• Sponsor: University of Chile
• Collaborators: Gladys Barrera Acevedo

Publications and helpful links

General Publications

• Wiklund IK, Fullerton S, Hawkey CJ, Jones RH, Longstreth GF, Mayer EA, Peacock RA, Wilson IK, Naesdal J. An irritable bowel syndrome-specific symptom questionnaire: development and validation. Scand J Gastroenterol. 2003 Sep;38(9):947-54. doi: 10.1080/00365520310004209.
• Liu Z, Yan S, Wu J, He L, Li N, Dong G, Fang J, Fu W, Fu L, Sun J, Wang L, Wang S, Yang J, Zhang H, Zhang J, Zhao J, Zhou W, Zhou Z, Ai Y, Zhou K, Liu J, Xu H, Cai Y, Liu B. Acupuncture for Chronic Severe Functional Constipation: A Randomized Trial. Ann Intern Med. 2016 Dec 6;165(11):761-769. doi: 10.7326/M15-3118. Epub 2016 Sep 13.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2020
• Primary Completion (ANTICIPATED): January 10, 2021
• Study Completion (ANTICIPATED): January 31, 2021

Study Registration Dates

• First Submitted: November 6, 2020
• First Submitted That Met QC Criteria: November 6, 2020
• First Posted (ACTUAL): November 12, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 12, 2020
• Last Update Submitted That Met QC Criteria: November 6, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: constipation; dyspepsia
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Gastrointestinal Diseases; Digestive System Diseases; Constipation
• Other Study ID Numbers: Manzana

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: All information will be in databases without any identification information of participants

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No