Innovative Tools to Produce Legume-based Foods for Increased Consumer Acceptance

NCT05118243 | Unknown

• 1 other identifier: LeguComf-HY
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

IBS - Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (10)

• The intensity of stomach pain measured by a visual analogue scale

  Study participants report the intensity of experienced stomach pain on a scale of zero (no pain at all) to 100 (very intense pain) using a mobile application. The data will be summarized in Excel form and the differences between the treatments will be analyzed statistically.

  2 weeks

• The intensity of stomach cramps measured by a visual analogue scale

  Study participants report the intensity of experienced stomach cramps on a scale of zero (no cramps at all) to 100 (very intense cramps) using a mobile application. The data will be summarized in Excel form and the differences between the treatments will be analyzed statistically.

  2 weeks

• The intensity of bloating measured by a visual analogue scale

  Study participants report the intensity of experienced bloating on a scale of zero (no bloating) to 100 (very bloated) using a mobile application. The data will be summarized in Excel form and the differences between the treatments will be analyzed statistically.

  2 weeks

• The intensity of flatulence measured by a visual analogue scale

  Study participants report the intensity of experienced flatulence on a scale of zero (no flatulence at all) to 100 (very intense flatulence) using a mobile application. The data will be summarized in Excel form and the differences between the treatments will be analyzed statistically.

  2 weeks

• The intensity of stomach noise measured by a visual analogue scale

  Study participants report the intensity of experienced stomach noise on a scale of zero (no noise at all) to 100 (very loud noise) using a mobile application. The data will be summarized in Excel form and the differences between the treatments will be analyzed statistically.

  2 weeks

• The intensity of nausea measured by a visual analogue scale

  Study participants report the intensity of experienced nausea on a scale of zero (no nausea at all) to 100 (very intense nausea) using a mobile application. The data will be summarized in Excel form and the differences between the treatments will be analyzed statistically.

  2 weeks

• The intensity of heartburn measured by a visual analogue scale

  Study participants report the intensity of experienced heartburn on a scale of zero (no heartburn at all) to 100 (very intense heartburn) using a mobile application. The data will be summarized in Excel form and the differences between the treatments will be analyzed statistically.

  2 weeks

• 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

  Study participants report the intensity of an unpleasant feeling in the upper abdomen or the feeling of feeling full fast related to eating on a scale of zero (no no described unpleasant feeling at all) to 100 (very intense unpleasant feeling) using a mobile application. The data will be summarized in Excel form and the differences between the treatments will be analyzed statistically.

  2 weeks

• The intensity of a sudden need to defecate measured by a visual analogue scale

  Study participants report the intensity of a sudden need to defecate on a scale of zero (no need to defecate at all) to 100 (very intense need to defecate) using a mobile application. The data will be summarized in Excel form and the differences between the treatments will be analyzed statistically.

  2 weeks

• The composition of gut microbiota analyzed from fecal samples using 16S rRNA amplicon sequencing

  The composition of gut microbiota is analyzed from fecal samples using 16S rRNA amplicon sequencing and qPCR (quantitative polymerase chain reaction). The differences between the treatments will be analyzed statistically.

  2 weeks

Study Arms (2)

Control cracker

ACTIVE COMPARATOR

All participants eat control crackers, which contain high amounts of GOS (approx. 5g GOS/daily portion of crackers)

Other: Control cracker

Enzyme-treated cracker

ACTIVE COMPARATOR

All participants eat enzyme-treated crackers, which contain minimal amounts of GOS (less than 1g GOS/daily portion of crackers)

Other: Enzyme-treated cracker

Interventions

Control cracker OTHER

The gut symptoms caused by control crackers are studied in IBS persons

Control cracker

Enzyme-treated cracker OTHER

The gut symptoms caused by enzyme-treated crackers are studied in IBS persons

Enzyme-treated cracker

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• IBS (Rome IV criteria) or functional bloating
• over 18 years old

You may not qualify if:

• IBD (inflammatory bowel disease)
• coeliac disease
• pregnancy or breastfeeding
• antibiotics within the last 3 months
• colonoscopy and preparations for it within 4 weeks

Sponsors & Collaborators

• University of Helsinki: lead

Study Sites (1)

University of Helsinki

Helsinki, Uusimaa, 00014, Finland

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Anne-Maria Pajari

  University of Helsinki

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The study is double-masked - neither the researchers or the participants know which cracker they are eating.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 8, 2021
• First Posted: November 11, 2021
• Study Start: September 6, 2021
• Primary Completion: August 1, 2022
• Study Completion: December 1, 2022
• Last Updated: May 18, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)