Clinical trial NCT04625881: Effects of an Apple Derived Fibre Supplement on Constipation
Official title: Effects of an Apple Derived Fibre Supplement on Digestive Symptoms and Evacuation Frequency in People With Constipation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Constipation
Functional Gastrointestinal Disorders
Keywords: constipation
dyspepsia
Lead sponsor: University of Chile
Sponsor class: OTHER
Collaborators: name: Gladys Barrera Acevedo
First posted: 2020-11-12
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blind parallel study comparing a fiber supplement with a fiberless placebo
Primary purpose: TREATMENT

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

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

Eligibility 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

Primary outcomes:
measure: Gastrointestinal symptom rating scale
timeFrame: every 2 weeks during 8 weeks
Secondary outcomes:
measure: Number of complete spontaneous bowel movements per week
timeFrame: every 2 weeks during 8 weeks
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Institute of Nutrition and Food Technology University of Chile
state: Metropolitana
Study officials:
References:
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. doi: 10.1080/00365520310004209.
citation: 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.