Effects of an Apple Derived Fibre Supplement on Constipation

Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04625881
• Other study ID #: Manzana
• Status: Recruiting
• Phase: Phase 3
• Start date: October 1, 2020
• Est. completion date: January 31, 2021

Study information

• Verified date: November 2020
• Source: University of Chile
• Contact: Francisco Perez, Ph D
• Phone: +56229781411
• Email: fperez[@]inta.uchile.cl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 31, 2021
• Est. primary completion date: January 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Constipation
• Digestive System Diseases
• Functional Gastrointestinal Disorders
• Gastrointestinal Diseases

Intervention

Dietary Supplement:
• Apple derived fiber
This is a combination of soluble and insoluble fiber

Locations

Country	Name	City	State
Chile	Institute of Nutrition and Food Technology University of Chile	Santiago	Metropolitana

Sponsors (2)

Lead Sponsor	Collaborator
University of Chile	Gladys Barrera Acevedo

Country where clinical trial is conducted

Chile, 

References & Publications (2)

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 I — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastrointestinal symptom rating scale	This scale assesses abdominal pain, bloating and type of stools	every 2 weeks during 8 weeks
Secondary	Number of complete spontaneous bowel movements per week	the title is auto-explicative	every 2 weeks during 8 weeks