Unidentified Stomach Discomfort Following Dairy ConsumptionNCT02219126
Effect of Homogenization and Pasteurization of Milk on the Stomach Problems in Adults
A study testing Dietary intervention in people with Unidentified Stomach Discomfort Following Dairy Consumption, run by University of Turku at 1 site in Finland.
Trial summary
This study aims to investigate differences in digestion rates and stomach problems caused by pasteurized and homogenized milk compared with raw milk in healthy adults by ingestible capsule that measures pH and pressure, diary of symptoms, blood glucose and triacylglycerol levels and plasma cytokine levels. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Unidentified Stomach Discomfort Following Dairy Consumption
- What is being tested?
- Dietary intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteFinland
- Study dates
- Aug 2014to 1 Jan 2018
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Homogenized and pasteurized milk causes stomach problems (self-reported)
- unhomogenized and unpasteurized milk does not cause stomach problems (self-reported)
- age 18-65
- BMI 18,5 - 30
- hemoglobin under normal range
- fasting plasma alanine aminotransferase ALAT < 60 U/l (normal liver function)
- fasting plasma thyroid-stimulating hormone (TSH) 0.4 - 4.5 mU/l (normal thyroid function)
- fasting plasma creatinine < 118 umol/l (normal kidney function)
Who cannot join
- pace maker
- Crohn's disease or other disease of the intestinal tract
- intestinal operation within the last 3 months
- difficult dysphagia
- smoking
- constipation
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to investigate differences in digestion rates and stomach problems caused by pasteurized and homogenized milk compared with raw milk in healthy adults by ingestible capsule that measures pH and pressure, diary of symptoms, blood glucose and triacylglycerol levels and plasma cytokine levels.
- Being tested
- Dietary intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Homogenized and pasteurized milk | Experimental | Milk that has undergone homogenization ans pasteurization treatment Receives: Other: Dietary intervention |
| Nonhomogenized and nonpasteurized milk | Experimental | Unhomogenized and unpasteurized milk (raw milk) Receives: Other: Dietary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure in the intestinal tract
Pressure in the intestinal tract as measured by ingestible Smart Pill -capsule.
Measured: Day 0 - Day 5
Gastrointestinal symptoms (self-reported)
Gastrointestinal symptoms (self-reported) as measured by a questionnaire. The questionnaire is devided into seven types of stomach discomfort, and also includes a possibility to describe a stomach discomfort outside these seven given alternatives. The severity of the symptoms is self-reported on a three-step scale.
Measured: Day 0 - Day 5
Secondary outcomes (4)
Plasma triacylglycerols
Measured: 20min, 40min, 60min, 120min, 180min, 240min
Plasma glucose
Measured: 20min, 40min, 60min, 90min, 120min, 180min, 240min
Plasma triacylglycerols
Measured: 20min, 40min, 60min, 90min, 120min, 180min, 240min
Plasma insulin
Measured: 20min, 40min, 60min, 90min, 120min, 180min, 240min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionMar 2016
- Study completion1 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unidentified Stomach Discomfort Following Dairy 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
- 11 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 M Linderborg, PhD, Principal investigator, University of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02219126
- Sponsor's protocol ID
- MILK
- Status last verified
- Jan 2018
- First submitted
- 14 Aug 2014
- Last updated
- 16 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Homogenization and Pasteurization of Milk on the Stomach Problems in Adults
- ClinicalTrials.gov ID
- NCT02219126
- Acronym / sponsor ID
- MILK
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 18 Aug 2014 (estimated)
- 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.
This study aims to investigate differences in digestion rates and stomach problems caused by pasteurized and homogenized milk compared with raw milk in healthy adults by ingestible capsule that measures pH and pressure, diary of symptoms, blood glucose and triacylglycerol levels and plasma cytokine levels.
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 |
|---|---|---|
| Homogenized and pasteurized milk | Experimental | Other: Dietary interventionMilk that has undergone homogenization ans pasteurization treatment |
| Nonhomogenized and nonpasteurized milk | Experimental | Other: Dietary interventionUnhomogenized and unpasteurized milk (raw milk) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Homogenized and pasteurized milk causes stomach problems (self-reported)
- unhomogenized and unpasteurized milk does not cause stomach problems (self-reported)
- age 18-65
- BMI 18,5 - 30
- hemoglobin under normal range
Key exclusion criteria (6 listed)
- pace maker
- Crohn's disease or other disease of the intestinal tract
- intestinal operation within the last 3 months
- difficult dysphagia
- smoking
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 |
|---|---|---|
| Dietary intervention | Other | Homogenized and pasteurized milk, Nonhomogenized and nonpasteurized milk |
Primary outcome
Pressure in the intestinal tract
Time frame: Day 0 - Day 5
Pressure in the intestinal tract as measured by ingestible Smart Pill -capsule.
Gastrointestinal symptoms (self-reported)
Time frame: Day 0 - Day 5
Gastrointestinal symptoms (self-reported) as measured by a questionnaire. The questionnaire is devided into seven types of stomach discomfort, and also includes a possibility to describe a stomach discomfort outside these seven given alternatives. The severity of the symptoms is self-reported on a three-step scale.
4 secondary outcomes
Plasma triacylglycerols
Time frame: 20min, 40min, 60min, 120min, 180min, 240min
Plasma glucose
Time frame: 20min, 40min, 60min, 90min, 120min, 180min, 240min
Plasma triacylglycerols
Time frame: 20min, 40min, 60min, 90min, 120min, 180min, 240min
Plasma insulin
Time frame: 20min, 40min, 60min, 90min, 120min, 180min, 240min
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 16 Jan 2018.
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 M Linderborg, PhD principal investigator
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 Dietary intervention in people with Unidentified Stomach Discomfort Following Dairy 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 8 inclusion and 6 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 16 Jan 2018. 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?
Pressure in the intestinal tract (time frame: Day 0 - Day 5). The study lists 2 primary outcomes in all. 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 16 Jan 2018.