- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04625881
Effects of an Apple Derived Fibre Supplement on Constipation
November 6, 2020 updated by: Daniel Bunout, University of Chile
Effects of an Apple Derived Fibre Supplement on Digestive Symptoms and Evacuation Frequency in People With Constipation
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
Study Overview
Status
Unknown
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Francisco Perez, Ph D
- Phone Number: +56229781411
- Email: fperez@inta.uchile.cl
Study Contact Backup
- Name: Rodrigo Troncoso, PhD
- Phone Number: +56229781486
- Email: rtroncoso@inta.uchile.cl
Study Locations
-
-
Metropolitana
-
Santiago, Metropolitana, Chile
- Recruiting
- Institute of Nutrition and Food Technology University of Chile
-
Contact:
- Veronica Cornejo, MSc
- Phone Number: +56229781411
- Email: vcornejo@inta.uchile.cl
-
Contact:
- Patricio Peirano, MD
- Phone Number: +562291781411
- Email: ppeirano@inta.uchile.cl
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Active product
A powder containing 20 g of apple derived fiber will be consumed daily
|
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
|
This is a combination of soluble and insoluble fiber
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gastrointestinal symptom rating scale
Time Frame: every 2 weeks during 8 weeks
|
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
Time Frame: every 2 weeks during 8 weeks
|
the title is auto-explicative
|
every 2 weeks during 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 1, 2020
Primary Completion (ANTICIPATED)
January 10, 2021
Study Completion (ANTICIPATED)
January 31, 2021
Study Registration Dates
First Submitted
November 6, 2020
First Submitted That Met QC Criteria
November 6, 2020
First Posted (ACTUAL)
November 12, 2020
Study Record Updates
Last Update Posted (ACTUAL)
November 12, 2020
Last Update Submitted That Met QC Criteria
November 6, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Manzana
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
All information will be in databases without any identification information of participants
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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