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Effects of an Apple Derived Fibre Supplement on Constipation

NCT ID: NCT04625881

Last Updated: 2020-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2021-01-31

Brief Summary

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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

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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

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Constipation Functional Gastrointestinal Disorders

Keywords

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constipation dyspepsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double blind parallel study comparing a fiber supplement with a fiberless placebo
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Active product and placebo will have the same appearance. All vials will have an unique numerical code

Study Groups

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Active product

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

Group Type ACTIVE_COMPARATOR

Apple derived fiber

Intervention Type DIETARY_SUPPLEMENT

This is a combination of soluble and insoluble fiber

Placebo

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

Group Type PLACEBO_COMPARATOR

Apple derived fiber

Intervention Type DIETARY_SUPPLEMENT

This is a combination of soluble and insoluble fiber

Interventions

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Apple derived fiber

This is a combination of soluble and insoluble fiber

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gladys Barrera Acevedo

UNKNOWN

Sponsor Role collaborator

University of Chile

OTHER

Sponsor Role lead

Responsible Party

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Daniel Bunout

Full professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Institute of Nutrition and Food Technology University of Chile

Santiago, Santiago Metropolitan, Chile

Site Status RECRUITING

Countries

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Chile

Central Contacts

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Francisco Perez, Ph D

Role: CONTACT

Phone: +56229781411

Email: [email protected]

Rodrigo Troncoso, PhD

Role: CONTACT

Phone: +56229781486

Email: [email protected]

Facility Contacts

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Veronica Cornejo, MSc

Role: primary

Patricio Peirano, MD

Role: backup

References

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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.

Reference Type RESULT
PMID: 14531531 (View on PubMed)

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.

Reference Type RESULT
PMID: 27618593 (View on PubMed)

Other Identifiers

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Manzana

Identifier Type: -

Identifier Source: org_study_id