- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05118243
Innovative Tools to Produce Legume-based Foods for Increased Consumer Acceptance (LeguComf)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A human intervention study with volunteers suffering from either irritable bowel syndrome (IBS) or functional bloating (FB) will be carried out to investigate the effects of enzymatic treatment of pea-based product on gastrointestinal symptoms and gut microbiota composition as well as hydrogen production due to carbohydrate fermentation. Enzyme-treated product will be compared to a control product.
The aim of the study is to investigate, whether enzyme-treated cracker, compared to a control product, will reduce gastrointestinaI symptoms, or have an impact on fecal microbiome or carbohydrate fermentation measured by breath hydrogen concentration. The effects of eating enzyme-treated crackers on food intake, exercise and stool frequency will also be investigated.
The study is carried out in a randomized, double-blinded, placebo-controlled crossover design. The study includes two 1-week treatment periods with 1-week run-in period before the intervention. Participants (N=35 at the maximum) are adult males and females who meet Rome IV criteria for IBS or FB.
Exclusion criteria will be as follows:
- coeliac disease
- inflammatory bowel disease
- pregnancy or breastfeeding
- antibiotics within the last 3 months
- colonoscopy and preparations for it within 4 weeks
During both treatment weeks each participant will receive three-day portion of either α-galactosidase-treated or control pea-based crackers. The participants will be advised to avoid foods that trigger their gastrointestinaI symptoms and otherwise follow their habitual diets for the whole 3-week study period. They will be asked to report severity of nine gastrointestinaI symptoms, keep food record, collect fecal samples, measure breath hydrogen and report their physical activity as well as stool frequency.
The participants will report their gastrointestinal symptoms throughout the study weeks (twice a day on cracker eating days, once on washout days). Physical activity and stool frequency will also be reported daily. Fecal samples will be collected during the run-in period (at baseline) and on third and seventh day of each treatment week. Breath hydrogen will be measured on second day of both treatment weeks. Nutrient intake and food consumption will be analyzed from 3-day food records during the run-in week and each treatment week (total 9 days). Nutrient intake will be calculated using a new Finnish 'Aromi Diet' software.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Uusimaa
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Helsinki, Uusimaa, Finland, 00014
- University of Helsinki
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- IBS (Rome IV criteria) or functional bloating
- over 18 years old
Exclusion Criteria:
- IBD (inflammatory bowel disease)
- coeliac disease
- pregnancy or breastfeeding
- antibiotics within the last 3 months
- colonoscopy and preparations for it within 4 weeks
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control cracker
All participants eat control crackers, which contain high amounts of GOS (approx.
5g GOS/daily portion of crackers)
|
The gut symptoms caused by control crackers are studied in IBS persons
|
Active Comparator: Enzyme-treated cracker
All participants eat enzyme-treated crackers, which contain minimal amounts of GOS (less than 1g GOS/daily portion of crackers)
|
The gut symptoms caused by enzyme-treated crackers are studied in IBS persons
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The intensity of stomach pain measured by a visual analogue scale
Time Frame: 2 weeks
|
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
Time Frame: 2 weeks
|
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
Time Frame: 2 weeks
|
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
Time Frame: 2 weeks
|
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
Time Frame: 2 weeks
|
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
Time Frame: 2 weeks
|
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
Time Frame: 2 weeks
|
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
Time Frame: 2 weeks
|
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
Time Frame: 2 weeks
|
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
Time Frame: 2 weeks
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anne-Maria Pajari, University of Helsinki
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LeguComf-HY
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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