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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
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04625881
Enrollment
60
Registered
2020-11-12
Start date
2020-10-01
Completion date
2021-01-31
Last updated
2020-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Constipation, Functional Gastrointestinal Disorders

Keywords

constipation, dyspepsia

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

Interventions

DIETARY_SUPPLEMENTApple derived fiber

This is a combination of soluble and insoluble fiber

Sponsors

Gladys Barrera Acevedo
CollaboratorUNKNOWN
University of Chile
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

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

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Gastrointestinal symptom rating scaleevery 2 weeks during 8 weeksThis scale assesses abdominal pain, bloating and type of stools

Secondary

MeasureTime frameDescription
Number of complete spontaneous bowel movements per weekevery 2 weeks during 8 weeksthe title is auto-explicative

Countries

Chile

Contacts

Primary ContactFrancisco Perez, Ph D
fperez@inta.uchile.cl+56229781411
Backup ContactRodrigo Troncoso, PhD
rtroncoso@inta.uchile.cl+56229781486

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026