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Effects of an Apple Derived Fibre Supplement on Constipation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04625881
Recruitment Status : Recruiting
First Posted : November 12, 2020
Last Update Posted : November 12, 2020
Sponsor:
Collaborator:
Gladys Barrera Acevedo
Information provided by (Responsible Party):
Daniel Bunout, University of Chile

Study Description
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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

Condition or disease Intervention/treatment Phase
Constipation Functional Gastrointestinal Disorders Dietary Supplement: Apple derived fiber Phase 3

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double blind parallel study comparing a fiber supplement with a fiberless placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Active product and placebo will have the same appearance. All vials will have an unique numerical code
Primary Purpose: Treatment
Official Title: Effects of an Apple Derived Fibre Supplement on Digestive Symptoms and Evacuation Frequency in People With Constipation
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : January 10, 2021
Estimated Study Completion Date : January 31, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Active product
A powder containing 20 g of apple derived fiber will be consumed daily
 Dietary Supplement: Apple derived fiber
This is a combination of soluble and insoluble fiber
Placebo Comparator: Placebo
A rice derived placebo devoid of fiber and aromatized with apple fragancy will be provided
 Dietary Supplement: Apple derived fiber
This is a combination of soluble and insoluble fiber


Outcome Measures
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Primary Outcome Measures :
  1. Gastrointestinal symptom rating scale [ Time Frame: every 2 weeks during 8 weeks ]
    This scale assesses abdominal pain, bloating and type of stools


Secondary Outcome Measures :
  1. Number of complete spontaneous bowel movements per week [ Time Frame: every 2 weeks during 8 weeks ]
    the title is auto-explicative


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04625881


Contacts
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Contact: Francisco Perez, Ph D +56229781411 fperez@inta.uchile.cl
Contact: Rodrigo Troncoso, PhD +56229781486 rtroncoso@inta.uchile.cl

Locations
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Chile
Institute of Nutrition and Food Technology University of Chile Recruiting
Santiago, Metropolitana, Chile
Contact: Veronica Cornejo, MSc    +56229781411    vcornejo@inta.uchile.cl   
Contact: Patricio Peirano, MD    +562291781411    ppeirano@inta.uchile.cl   
Sponsors and Collaborators
University of Chile
Gladys Barrera Acevedo
More Information
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Publications of Results:

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Responsible Party: Daniel Bunout, Full professor, University of Chile
ClinicalTrials.gov Identifier: NCT04625881    
Other Study ID Numbers: Manzana
First Posted: November 12, 2020    Key Record Dates
Last Update Posted: November 12, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: All information will be in databases without any identification information of participants

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Daniel Bunout, University of Chile:
constipation
dyspepsia
Additional relevant MeSH terms:
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Gastrointestinal Diseases
Digestive System Diseases
Constipation
Signs and Symptoms, Digestive