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Effects of an Apple Derived Fibre Supplement on Constipation

Primary Purpose

Constipation, Functional Gastrointestinal Disorders

Status

Unknown status

Phase

Phase 3

Locations

Chile

Study Type

Interventional

Intervention

Apple derived fiber

About this trial

This is an interventional treatment trial for Constipation focused on measuring constipation, dyspepsia

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Institute of Nutrition and Food Technology University of ChileRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active product

Placebo

Arm Description

A powder containing 20 g of apple derived fiber will be consumed daily

A rice derived placebo devoid of fiber and aromatized with apple fragancy will be provided

Outcomes

Primary Outcome Measures

Gastrointestinal symptom rating scale

This scale assesses abdominal pain, bloating and type of stools

Secondary Outcome Measures

Number of complete spontaneous bowel movements per week

the title is auto-explicative

Full Information

NCT ID

NCT04625881

First Posted

November 6, 2020

Last Updated

November 6, 2020

Sponsor

University of Chile

Collaborators

Gladys Barrera Acevedo

1. Study Identification

Unique Protocol Identification Number

NCT04625881

Brief Title

Effects of an Apple Derived Fibre Supplement on Constipation

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Unknown status

Study Start Date

October 1, 2020 (Actual)

Primary Completion Date

January 10, 2021 (Anticipated)

Study Completion Date

January 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Chile

Collaborators

Gladys Barrera Acevedo

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Constipation, Functional Gastrointestinal Disorders

Keywords

constipation, dyspepsia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

Double blind parallel study comparing a fiber supplement with a fiberless placebo

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Active product and placebo will have the same appearance. All vials will have an unique numerical code

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Active product

Arm Type

Active Comparator

Arm Description

A powder containing 20 g of apple derived fiber will be consumed daily

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

A rice derived placebo devoid of fiber and aromatized with apple fragancy will be provided

Intervention Type

Dietary Supplement

Intervention Name(s)

Apple derived fiber

Intervention Description

This is a combination of soluble and insoluble fiber

Primary Outcome Measure Information:

Title

Gastrointestinal symptom rating scale

Description

This scale assesses abdominal pain, bloating and type of stools

Time Frame

every 2 weeks during 8 weeks

Secondary Outcome Measure Information:

Title

Number of complete spontaneous bowel movements per week

Description

the title is auto-explicative

Time Frame

every 2 weeks during 8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Francisco Perez, Ph D

Phone

+56229781411

fperez@inta.uchile.cl

First Name & Middle Initial & Last Name or Official Title & Degree

Rodrigo Troncoso, PhD

Phone

+56229781486

rtroncoso@inta.uchile.cl

Facility Information:

Facility Name

Institute of Nutrition and Food Technology University of Chile

City

Santiago

State/Province

Metropolitana

Country

Chile

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Veronica Cornejo, MSc

Phone

+56229781411

vcornejo@inta.uchile.cl

First Name & Middle Initial & Last Name & Degree

Patricio Peirano, MD

Phone

+562291781411

ppeirano@inta.uchile.cl

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

All information will be in databases without any identification information of participants

Citations:

PubMed Identifier

14531531

Citation

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.

Results Reference

result

PubMed Identifier

27618593

Citation

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.

Results Reference

result

Learn more about this trial

Effects of an Apple Derived Fibre Supplement on Constipation

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