Innovative Tools to Produce Legume-based Foods for Increased Consumer Acceptance - Trial NCT05118243
Access comprehensive clinical trial information for NCT05118243 through Pure Global AI's free database. This phase not specified trial is sponsored by University of Helsinki and is currently Active, not recruiting. The study focuses on IBS - Irritable Bowel Syndrome. Target enrollment is 20 participants.
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Study Focus
Sponsor & Location
University of Helsinki
Timeline & Enrollment
N/A
Sep 06, 2021
Dec 01, 2022
Primary Outcome
The intensity of stomach pain measured by a visual analogue scale,The intensity of stomach cramps measured by a visual analogue scale,The intensity of bloating measured by a visual analogue scale,The intensity of flatulence measured by a visual analogue scale,The intensity of stomach noise measured by a visual analogue scale,The intensity of nausea measured by a visual analogue scale,The intensity of heartburn measured by a visual analogue scale,The intensity of an unpleasant feeling in the upper abdomen or the feeling of feeling full fast related to eating measured by a visual analogue scale,The intensity of a sudden need to defecate measured by a visual analogue scale,The composition of gut microbiota analyzed from fecal samples using 16S rRNA amplicon sequencing
Summary
The aim of this study is to investigate the effects of enzymatic treatment to reduce GOS
 (galactooligosaccharides) in legume-based crackers in IBS (irritable bowel syndrome) persons.
 The crackers are pea-based: the control crackers contain high amounts of GOS, while the
 enzymatically treated crackers contain a minimal amount of GOS. The participants will eat
 each type of cracker for three days (daily dose of 12 crackers) and report their gut symptoms
 (e.g. flatulence, stomach pain, bloating) by using a mobile app. There is a washout period of
 four days between the different crackers. In addition, the participants will keep food
 records on the cracker eating days as well as collect five fecal samples during the study.
 The participants will also report their physical activity and the number of defecations on
 each day. The study is carried out in a double-blinded crossover setting.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT05118243
Non-Device Trial