- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04273659
Combining Cereals With Pulses - Reduced Gastrointestinal Symptoms?
October 4, 2021 updated by: Kaisa Linderborg, University of Turku
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Turku, Finland, 20014
- Department of Biochemistry, University of Turku
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 64 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pulses and Cereal 1
Pulses and cereal 1 containing study product is served.
Dietary intervention.
|
Dietary intervention.
Ingestion of pulses with cereals and gastrointestinal health.
|
Experimental: Pulses and Cereal 2
Pulses and cereal 2 containing study product is served.
Dietary intervention.
|
Dietary intervention.
Ingestion of pulses with cereals and gastrointestinal health.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Breath gases
Time Frame: Day 4
|
Breath hydrogen and methane are measured by Gastrocheck device.
|
Day 4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gastrointestinal symptoms (self-reported)
Time Frame: Day 1-4
|
Gastrointestinal symptoms as measured as questionnaires.
|
Day 1-4
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kaisa Linderborg, PhD, Department of Biochemistry, University of Turku
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 12, 2020
Primary Completion (Actual)
August 30, 2021
Study Completion (Actual)
August 30, 2021
Study Registration Dates
First Submitted
February 14, 2020
First Submitted That Met QC Criteria
February 14, 2020
First Posted (Actual)
February 18, 2020
Study Record Updates
Last Update Posted (Actual)
October 5, 2021
Last Update Submitted That Met QC Criteria
October 4, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pulses
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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