HealthyNCT05511077
Biomarkers of Oat Product Intake: The BiOAT Marker Study
A study testing Diet in people with Healthy, run by Chalmers University of Technology at 1 site in Sweden.
Trial summary
The aim of this project is to evaluate avenanthramides and avenacosides and their metabolites as specific biomarkers of oat product intake in humans. Biomarkers will be evaluated after i) a single dose through a single meal based on a solid and a liquid oat-based product (pharmacokinetic study) ii) week-long… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteSweden
- Study dates
- 9 Sep 2022to 19 Dec 2022
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Females and males
- Age 18-80 years
- Body mass index (BMI) 18.5-30 kg/m2
- Fasting glucose ≤ 6.1 mmol/l
- Low density lipoprotein (LDL) Cholesterol ≤ 5.30 mmol/L
- Triglycerides ≤ 2.60 mmol/L
- Signed informed consent
Who cannot join
- Food allergies or intolerances preventing consumption of any products included in the study.
- Unable to sufficiently understand written and spoken Swedish to provide written consent and understand information and instructions from the study personal.
- Pregnant, lactating or planning a pregnancy during the study period.
- Antibiotic use for the last 3 months.
- Blood donation or participation in a clinical study with blood sampling within 30 days prior to screening visit and throughout the study.
- History of stomach or gastrointestinal conditions (Inflammatory bowel disease, Crohn's disease, malabsorption, colostomy, bowel resection, gastric bypass surgery etc.)
Show all 9Show fewer
- Previous major gastrointestinal surgery
- Have type I diabetes
- Thyroid disorder
Trial locations and contacts
1 site in 1 country.
Sweden1 site
University of Gothenburg, Department of Food and Nutrition and Sport Science
Gothenburg
About this study
The aim of this project is to evaluate avenanthramides and avenacosides and their metabolites as specific biomarkers of oat product intake in humans. Biomarkers will be evaluated after i) a single dose through a single meal based on a solid and a liquid oat-based product (pharmacokinetic study) ii) week-long consumption at three different intake levels (dose-response). The study will be carried out as a two-way cross-over design with two different oat products, liquid or solid, where each product is provided 3 times per day during 5 days per product. A wash-out period of 8 days where participants consume their habitual diet is implemented. The first day of study meal intervention includes postprandial measurements during 8 hours.
- Conditions
- Healthy
- Being tested
- Diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietOther
Intervention products consist of two different oat products, one solid and one liquid. The content of oat in the products differs.
| Study group | Role | What they receive |
|---|---|---|
| Liquid oat product | Other | Not described Receives: Other: Diet |
| Solid oat product | Other | Not described Receives: Other: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentrations of avenanthramides and avenacosides and their metabolites.
Difference in the plasma concentrations of diet specific biomarkers comparing before (baseline) and after intervention meal (average plasma concentration over a 24 h period).
Measured: 24 hours
Plasma concentration-time profile over 24h (AUCs) of avenanthramides and avenacosides and their metabolites.
Differences in plasma AUCs between the intake levels for each biomarker candidate.
Measured: 24 hours
Urine concentrations of avenanthramides and avenacosides and their metabolites
Difference in the plasma concentrations of diet specific biomarkers comparing before (baseline) and after intervention meal (average urine concentration over a 8 h period).
Measured: 8 hours
Secondary outcomes (4)
Gut microbiome
Fecal samples will analyzed for composition of the gut microbiome, baseline compared with after 5 days of intervention products.
Measured: 5 days
Plasma metabolites
Untargeted metabolomics will be performed using established methods for plasma. Analyzed exploratorily using untargeted metabolomics to find potential biomarker panels that reflect oats product intake. Baseline compared with after intervention products.
Measured: 5 days
Urine metabolites
Untargeted metabolomics will be performed using established methods for urine. Analyzed exploratorily using untargeted metabolomics to find potential biomarker panels that reflect oats product intake.
Measured: 24 hours
Blood concentrations of avenanthramides and avenacosides and their metabolites
Evaluate new simple sampling techniques using dried blood spots.
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start9 Sep 2022
- Primary completion19 Dec 2022
- Study completion19 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chalmers University of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Oatly Group Inc
- Responsible party
- Principal investigator, Rikard Landberg, Chalmers University of Technology
- Investigators
- Rikard Landberg, Dr, Principal investigator, Chalmers University of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05511077
- Sponsor's protocol ID
- ChalmersU
- Status last verified
- Feb 2023
- First submitted
- 19 Aug 2022
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Armeni M, Cardilin T, Fristedt R, Karlsson T, Jenkins CO, Nordin E, Qin P, Jirstrand M, Kristiansen K, Savolainen O, Landberg R. Avenanthramides and avenacosides as biomarkers of oat intake: a pharmacokinetic study of solid and liquid oat consumption under single and repeated dose conditions. Nutr J. 2025 Sep 9;24(1):136. doi: 10.1186/s12937-025-01204-7.
PubMed 40926245
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers of Oat Product Intake: The BiOAT Marker Study
- ClinicalTrials.gov ID
- NCT05511077
- Acronym / sponsor ID
- ChalmersU
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Chalmers University of TechnologyUniversity, hospital or other
- Collaborators
- Oatly Group Inc
- Study start
- 9 Sep 2022 (actual)
- Primary completion
- 19 Dec 2022 (actual)
- Study completion
- 19 Dec 2022 (actual)
- First posted
- 22 Aug 2022 (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 this project is to evaluate avenanthramides and avenacosides and their metabolites as specific biomarkers of oat product intake in humans. Biomarkers will be evaluated after i) a single dose through a single meal based on a solid and a liquid oat-based product (pharmacokinetic study) ii) week-long consumption at three different intake levels (dose-response). The study will be carried out as a two-way cross-over design with two different oat products, liquid or solid, where each product is provided 3 times per day during 5 days per product. A wash-out period of 8 days where participants consume their habitual diet is implemented. The first day of study meal intervention includes postprandial measurements during 8 hours.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liquid oat product | Other | Other: Diet |
| Solid oat product | Other | Other: Diet |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Females and males
- Age 18-80 years
- Body mass index (BMI) 18.5-30 kg/m2
- Fasting glucose ≤ 6.1 mmol/l
- Low density lipoprotein (LDL) Cholesterol ≤ 5.30 mmol/L
Key exclusion criteria (9 listed)
- Food allergies or intolerances preventing consumption of any products included in the study.
- Unable to sufficiently understand written and spoken Swedish to provide written consent and understand information and instructions from the study personal.
- Pregnant, lactating or planning a pregnancy during the study period.
- Antibiotic use for the last 3 months.
- Blood donation or participation in a clinical study with blood sampling within 30 days prior to screening visit and throughout the study.
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 |
|---|---|---|
| DietIntervention products consist of two different oat products, one solid and one liquid. The content of oat in the products differs. | Other | Liquid oat product, Solid oat product |
Primary outcome
Plasma concentrations of avenanthramides and avenacosides and their metabolites.
Time frame: 24 hours
Difference in the plasma concentrations of diet specific biomarkers comparing before (baseline) and after intervention meal (average plasma concentration over a 24 h period).
Plasma concentration-time profile over 24h (AUCs) of avenanthramides and avenacosides and their metabolites.
Time frame: 24 hours
Differences in plasma AUCs between the intake levels for each biomarker candidate.
Urine concentrations of avenanthramides and avenacosides and their metabolites
Time frame: 8 hours
Difference in the plasma concentrations of diet specific biomarkers comparing before (baseline) and after intervention meal (average urine concentration over a 8 h period).
4 secondary outcomes
Gut microbiome
Time frame: 5 days
Plasma metabolites
Time frame: 5 days
Urine metabolites
Time frame: 24 hours
Blood concentrations of avenanthramides and avenacosides and their metabolites
Time frame: 8 hours
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 21 Feb 2023.
- Derived from this study: PubMed 40926245Armeni M, Cardilin T, Fristedt R, Karlsson T, Jenkins CO, Nordin E, Qin P, Jirstrand M, Kristiansen K, Savolainen O, Landberg R. Avenanthramides and avenacosides as biomarkers of oat intake: a pharmacokinetic study of solid and liquid oat consumption under single and repeated dose conditions. Nutr J. 2025 Sep 9;24(1):136. doi: 10.1186/s12937-025-01204-7.
- Individual participant dataSharing planned: No
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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.
Rikard Landberg, Dr principal investigator
Chalmers University of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet in people with Healthy, run by Chalmers University of Technology at 1 site in Sweden.
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 7 inclusion and 9 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 21 Feb 2023. 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 Sweden. 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?
Plasma concentrations of avenanthramides and avenacosides and their metabolites. (time frame: 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05511077, which also lists 1 linked publication.
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 21 Feb 2023; AzTrials last refreshed its copy on 7 Nov 2026.