Effects of an Apple Derived Fibre Supplement on Constipation

Study Overview
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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

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

Conditions
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Constipation, Functional Gastrointestinal Disorders

Intervention / Treatment
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* Dietary Supplement: Apple derived fiber


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double blind parallel study comparing a fiber supplement with a fiberless placebo
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active product<br>A powder containing 20 g of apple derived fiber will be consumed daily | Dietary Supplement: Apple derived fiber<br>* This is a combination of soluble and insoluble fiber<br>|
| Placebo Comparator: Placebo<br>A rice derived placebo devoid of fiber and aromatized with apple fragancy will be provided | Dietary Supplement: Apple derived fiber<br>* This is a combination of soluble and insoluble fiber<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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constipation, dyspepsia