Effects of an Apple Derived Fibre Supplement on Constipation

University of Chile

Status and phase: Unknown; Phase 3

Conditions: Functional Gastrointestinal Disorders; Constipation

Treatments: Dietary Supplement: Apple derived fiber

Study type: Interventional

Funder types: Other

Identifiers

NCT04625881

Manzana

Details and patient eligibility

About

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

Full 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

Enrollment: 60 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Active product

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Apple derived fiber

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Apple derived fiber