Unidentified Gastrointestinal Symptoms Following Pulses ConsumptionNCT04273659
Combining Cereals With Pulses - Reduced Gastrointestinal Symptoms?
A study testing Pulses and cereals in people with Unidentified Gastrointestinal Symptoms Following Pulses Consumption, run by University of Turku at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Unidentified Gastrointestinal Symptoms Following Pulses Consumption
- What is being tested?
- Pulses and cereals
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteFinland
- Study dates
- 12 Feb 2020to 30 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Pulses and cereals
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulses and cerealsDietary supplement
Dietary intervention. Ingestion of pulses with cereals and gastrointestinal health.
| Study group | Role | What they receive |
|---|---|---|
| Pulses and Cereal 1 | Experimental | Pulses and cereal 1 containing study product is served. Dietary intervention. Receives: Dietary Supplement: Pulses and cereals |
| Pulses and Cereal 2 | Experimental | Pulses and cereal 2 containing study product is served. Dietary intervention. Receives: Dietary Supplement: Pulses and cereals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breath gases
Breath hydrogen and methane are measured by Gastrocheck device.
Measured: Day 4
Secondary outcomes (1)
Gastrointestinal symptoms (self-reported)
Gastrointestinal symptoms as measured as questionnaires.
Measured: Day 1-4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start12 Feb 2020
- Primary completion30 Aug 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unidentified Gastrointestinal Symptoms Following Pulses ConsumptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kaisa Linderborg, University of Turku
- Investigators
- Kaisa Linderborg, PhD, Principal investigator, Department of Biochemistry, University of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04273659
- Sponsor's protocol ID
- Pulses
- Status last verified
- Oct 2021
- First submitted
- 14 Feb 2020
- Last updated
- 5 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Cereals With Pulses - Reduced Gastrointestinal Symptoms?
- ClinicalTrials.gov ID
- NCT04273659
- Acronym / sponsor ID
- Pulses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Study start
- 12 Feb 2020 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 18 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulses and Cereal 1 | Experimental | Dietary Supplement: Pulses and cerealsPulses and cereal 1 containing study product is served. Dietary intervention. |
| Pulses and Cereal 2 | Experimental | Dietary Supplement: Pulses and cerealsPulses and cereal 2 containing study product is served. Dietary intervention. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulses and cerealsDietary intervention. Ingestion of pulses with cereals and gastrointestinal health. | Dietary supplement | Pulses and Cereal 1, Pulses and Cereal 2 |
Primary outcome
Breath gases
Time frame: Day 4
Breath hydrogen and methane are measured by Gastrocheck device.
1 secondary outcome
Gastrointestinal symptoms (self-reported)
Time frame: Day 1-4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kaisa Linderborg, PhD principal investigator
Department of Biochemistry, University of Turku
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulses and cereals in people with Unidentified Gastrointestinal Symptoms Following Pulses Consumption, run by University of Turku at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breath gases (time frame: Day 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2021.