Back to resultsCombining Cereals With Pulses - Reduced Gastrointestinal Symptoms?
Primary Purpose
Unidentified Gastrointestinal Symptoms Following Pulses Consumption
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Pulses and cereals
Sponsored by
About this trial
This is an interventional basic science trial for Unidentified Gastrointestinal Symptoms Following Pulses Consumption
Eligibility Criteria
Inclusion Criteria:
- Healthy subjects with subjective experience of gut symptoms after consumption of pulses
- Celiac disease and wheat allergy excluded by antigen test
- Age 18-65
- BMI 18,5 - 30
- Normal liver, thyroid and kidney functions
Exclusion Criteria:
- Celiac disease, Crohn's disease, ulcerative colitis or acute diverticulitis
- Any medication affecting the gastrointestinal tract (e.g. laxatives and acid-suppressive drugs)
- Antibiotic treatment within previous 3 months
- Blood donation or participation to another clinical trial within one month prior to study entry
Sites / Locations
- Department of Biochemistry, University of Turku
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Pulses and Cereal 1
Pulses and Cereal 2
Arm Description
Pulses and cereal 1 containing study product is served. Dietary intervention.
Pulses and cereal 2 containing study product is served. Dietary intervention.
Outcomes
Primary Outcome Measures
Breath gases
Breath hydrogen and methane are measured by Gastrocheck device.
Secondary Outcome Measures
Gastrointestinal symptoms (self-reported)
Gastrointestinal symptoms as measured as questionnaires.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04273659
Brief Title
Combining Cereals With Pulses - Reduced Gastrointestinal Symptoms?
Official Title
Combining Cereals With Pulses - Reduced Gastrointestinal Symptoms?
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
February 12, 2020 (Actual)
Primary Completion Date
August 30, 2021 (Actual)
Study Completion Date
August 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Turku
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the study is to compare self-reported gastrointestinal symptoms and intestinal fermentation rates of the study products as measured by breath hydrogen and methane in adult population with self-reported mild abdominal sensitivity to pulses. The study products are a pulse products with two different cereals.
Detailed Description
The study is a randomized, controlled, double-blind, cross-over intervention trial. The aim is to recruit 25 subjects to the trial. The study will be conducted with a cross-over setting, where the subjects will go through exposure meals and breath gas measurement two times (two different test products) in a randomized order. The study meals are identical in appearance but differ in fiber content. After study breakfast the breath gases are analyzed every 15 minutes during 8 hours.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unidentified Gastrointestinal Symptoms Following Pulses Consumption
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pulses and Cereal 1
Arm Type
Experimental
Arm Description
Pulses and cereal 1 containing study product is served. Dietary intervention.
Arm Title
Pulses and Cereal 2
Arm Type
Experimental
Arm Description
Pulses and cereal 2 containing study product is served. Dietary intervention.
Intervention Type
Dietary Supplement
Intervention Name(s)
Pulses and cereals
Intervention Description
Dietary intervention. Ingestion of pulses with cereals and gastrointestinal health.
Primary Outcome Measure Information:
Title
Breath gases
Description
Breath hydrogen and methane are measured by Gastrocheck device.
Time Frame
Day 4
Secondary Outcome Measure Information:
Title
Gastrointestinal symptoms (self-reported)
Description
Gastrointestinal symptoms as measured as questionnaires.
Time Frame
Day 1-4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy subjects with subjective experience of gut symptoms after consumption of pulses
Celiac disease and wheat allergy excluded by antigen test
Age 18-65
BMI 18,5 - 30
Normal liver, thyroid and kidney functions
Exclusion Criteria:
Celiac disease, Crohn's disease, ulcerative colitis or acute diverticulitis
Any medication affecting the gastrointestinal tract (e.g. laxatives and acid-suppressive drugs)
Antibiotic treatment within previous 3 months
Blood donation or participation to another clinical trial within one month prior to study entry
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kaisa Linderborg, PhD
Organizational Affiliation
Department of Biochemistry, University of Turku
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Biochemistry, University of Turku
City
Turku
ZIP/Postal Code
20014
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Combining Cereals With Pulses - Reduced Gastrointestinal Symptoms?
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