Mycotoxin BiomonitoringHISU_101NCT07050680
How Healthy Are Your Oats?
A study testing Dietary intervention in people with Mycotoxin Biomonitoring, run by University of Aberdeen at 1 site in United Kingdom.
Trial summary
Oat foods are commonly consumed as healthy breakfast options and their nutritional value is well recognised. Oats are a rich source of fibre, micronutrients and non-nutrient bioactive compounds, but at the same time cereals including oats can be contaminated with mycotoxins. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Mycotoxin Biomonitoring
- What is being tested?
- Dietary intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Jun 2025to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adult males and females (aged 18 - 65 years) who are healthy with a BMI in the normal to overweight range (18.5-29.9)
Who cannot join
- Anyone who currently suffers from gastrointestinal or metabolic diseases, liver disease or kidney disease
- Anyone who currently has an eating disorder (anorexia, bulimia, binge eating, night eating syndrome)
- Anyone who is taking prescribed medication related to gastrointestinal, metabolic, liver or kidney disease
- Anyone who has taken antibiotics in the past 3 months
- Anyone who is allergic or intolerant to oat foods
- Anyone who is currently pregnant or breastfeeding
Show all 10Show fewer
- Anyone who is currently taking vitamin or mineral supplements (unless they agree to discontinue supplementation 2 weeks before the study)
- Anyone currently participating in another research study
- Anyone who is unable to fluently speak, read and understand English
- Anyone who is unable to give written informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Rowett Institute, University of Aberdeen
Aberdeen, AB25 2ZD
About this study
Official title: Assessment of Bioaccessibility of Oat Bioactive Compounds and Contaminants in Human Volunteers
Oat foods are commonly consumed as healthy breakfast options and their nutritional value is well recognised. Oats are a rich source of fibre, micronutrients and non-nutrient bioactive compounds, but at the same time cereals including oats can be contaminated with mycotoxins. To fully understand the nutritional benefits and potential food safety risks of oat consumption, this study aims to assess the nutritional composition of an oat food and the bioavailability of bioactive oat constituents and their metabolite profile in urine of volunteers consuming a single portion of an oat breakfast. This study requires 16 healthy volunteers to consume one portion of oats and collect their urine over 48 hours after the test meal. No other sample collection is required.
Read the detailed description
Cereal foods are important part of a healthy, balanced diet. Amongst cereals, oats form an important part of a Scottish diet and are an important agricultural commodity. Oats are well-known for their high nutritional value containing high-quality fatty acids (oleic and linoleic acids), proteins with high amino acid profiles and dietary fibre, most namely in the form of soluble β-glucans. These β-glucans have well-documented health benefits regarding cholesterol-lowering effects in humans. In addition to macronutrients, oats are also a rich source of micronutrients including tocopherols and a range of minerals. As such, the consumption of oats is highly recommended by dietary advice. However, oats and other cereals are also known to be at risk of contamination with naturally occurring fungal toxins called mycotoxins. Previous studies have demonstrated the presence of detectable levels of mycotoxins formed by Fusarium fungi in oat crops and oat foods. Current risk assessments by the European Food Safety Authority and the UK Food Standard Agency aim to establish maximum permitted levels of these mycotoxins in foods. The maximum levels aim to protect consumers from high level exposure and potential health effects.
Rationale for Study This study is part of a wider programme of work investigating the health benefits and potential food safety risks of oats. The presence of phytochemicals and Fusarium mycotoxins in oat foods has been confirmed and the bioaccessibility of these bioactive compounds in the human gut has been demonstrated in-vitro. To fully quantify dietary exposure of individuals to these bioactive compounds, detailed work is needed to understand the rate of bioaccessibility of bioactive compounds from oat foods and their absorption and excretion into urine in humans. This detailed information will inform future studies aimed at assessing dietary exposure and risk.
The proposed study aims to feed a single dose of an oat food to healthy volunteers. The study will assess how the oat food is digested and the bioactive compounds absorbed and excreted in vivo. The food will be selected to contain low and safe mycotoxin levels.
- Conditions
- Mycotoxin Biomonitoring
- Being tested
- Dietary intervention
- Keywords
- Human exposure, Toxicokinetics, Urinary excretion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary interventionOther
Single dose of commercially available Oat food test meal
| Study group | Role | What they receive |
|---|---|---|
| Oat intervention arm | Experimental | All participants will consume a single dose of an oat test meal Receives: Other: Dietary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinetics of mycotoxin absorption and excretion
Urinary excretion profile of oat-derived mycotoxins and metabolites will be assessed after consumption of a single oat-based test meal in 16 volunteers. Volunteers will collect hourly urine samples. Samples will be analysed for mycotoxin metabolites using established LC-MS/MS methodology.
Measured: Hourly urine sample collection up to 16 hours post-intervention, then bulk urine collection at 24 and 48 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start2 Jun 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mycotoxin BiomonitoringStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07050680
- Sponsor's protocol ID
- 2-037-25
- Acronym
- HISU_101
- Status last verified
- Oct 2026
- First submitted
- 19 Jun 2025
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Bioaccessibility of Oat Bioactive Compounds and Contaminants in Human Volunteers
- ClinicalTrials.gov ID
- NCT07050680
- Acronym / sponsor ID
- HISU_101 / 2-037-25
- Conditions
- Mycotoxin Biomonitoring
- Keywords
- Human exposure, Toxicokinetics, Urinary excretion
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 3 Jul 2025 (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.
Oat foods are commonly consumed as healthy breakfast options and their nutritional value is well recognised. Oats are a rich source of fibre, micronutrients and non-nutrient bioactive compounds, but at the same time cereals including oats can be contaminated with mycotoxins. To fully understand the nutritional benefits and potential food safety risks of oat consumption, this study aims to assess the nutritional composition of an oat food and the bioavailability of bioactive oat constituents and their metabolite profile in urine of volunteers consuming a single portion of an oat breakfast. This study requires 16 healthy volunteers to consume one portion of oats and collect their urine over 48 hours after the test meal. No other sample collection is required.
Detailed description
Cereal foods are important part of a healthy, balanced diet. Amongst cereals, oats form an important part of a Scottish diet and are an important agricultural commodity. Oats are well-known for their high nutritional value containing high-quality fatty acids (oleic and linoleic acids), proteins with high amino acid profiles and dietary fibre, most namely in the form of soluble β-glucans. These β-glucans have well-documented health benefits regarding cholesterol-lowering effects in humans. In addition to macronutrients, oats are also a rich source of micronutrients including tocopherols and a range of minerals. As such, the consumption of oats is highly recommended by dietary advice. However, oats and other cereals are also known to be at risk of contamination with naturally occurring fungal toxins called mycotoxins. Previous studies have demonstrated the presence of detectable levels of mycotoxins formed by Fusarium fungi in oat crops and oat foods. Current risk assessments by the European Food Safety Authority and the UK Food Standard Agency aim to establish maximum permitted levels of these mycotoxins in foods. The maximum levels aim to protect consumers from high level exposure and potential health effects.
Rationale for Study This study is part of a wider programme of work investigating the health benefits and potential food safety risks of oats. The presence of phytochemicals and Fusarium mycotoxins in oat foods has been confirmed and the bioaccessibility of these bioactive compounds in the human gut has been demonstrated in-vitro. To fully quantify dietary exposure of individuals to these bioactive compounds, detailed work is needed to understand the rate of bioaccessibility of bioactive compounds from oat foods and their absorption and excretion into urine in humans. This detailed information will inform future studies aimed at assessing dietary exposure and risk.
The proposed study aims to feed a single dose of an oat food to healthy volunteers. The study will assess how the oat food is digested and the bioactive compounds absorbed and excreted in vivo. The food will be selected to contain low and safe mycotoxin levels.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oat intervention arm | Experimental | Other: Dietary interventionAll participants will consume a single dose of an oat test meal |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult males and females (aged 18 - 65 years) who are healthy with a BMI in the normal to overweight range (18.5-29.9)
Key exclusion criteria (10 listed)
- Anyone who currently suffers from gastrointestinal or metabolic diseases, liver disease or kidney disease
- Anyone who currently has an eating disorder (anorexia, bulimia, binge eating, night eating syndrome)
- Anyone who is taking prescribed medication related to gastrointestinal, metabolic, liver or kidney disease
- Anyone who has taken antibiotics in the past 3 months
- Anyone who is allergic or intolerant to oat foods
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 interventionSingle dose of commercially available Oat food test meal | Other | Oat intervention arm |
Primary outcome
Kinetics of mycotoxin absorption and excretion
Time frame: Hourly urine sample collection up to 16 hours post-intervention, then bulk urine collection at 24 and 48 hours.
Urinary excretion profile of oat-derived mycotoxins and metabolites will be assessed after consumption of a single oat-based test meal in 16 volunteers. Volunteers will collect hourly urine samples. Samples will be analysed for mycotoxin metabolites using established LC-MS/MS methodology.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: No
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Malnutrition Pregnancy, Malnutrition in Children
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Mycotoxin Biomonitoring, run by University of Aberdeen at 1 site in United Kingdom.
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 1 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 8 Oct 2026. 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 United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
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?
Kinetics of mycotoxin absorption and excretion (time frame: Hourly urine sample collection up to 16 hours post-intervention, then bulk urine collection at 24 and 48 hours.). 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 8 Oct 2026.