Dietary ExposureNCT05668832
Bioavailability of Vitamin D Photoisomers From UVB-exposed Button Mushrooms
A study testing UVB-exposed button mushrooms in people with Dietary Exposure and Safety Issues, run by Martin-Luther-Universität Halle-Wittenberg.
Trial summary
The European Food Safety Authority has approved many applications for UVB light treated foods (e.g. UVB-exposed button mushrooms) in the last years. The UVB light treatment is used to increase the vitamin D content in foods and improve the vitamin D status of subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Exposure, Safety Issues
- What is being tested?
- UVB-exposed button mushrooms
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 9 Jan 2023to 30 Jul 2024
- 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
- Healthy subjects
- Age between 18 and 65 years
- Body Mass Index in the range of 18.5 to 29.9 kg/m2
Who cannot join
- Acute or chronic illnesses (high blood pressure, heart disease, diabetes, kidney disease, liver disease, alcohol dependence, etc.)
- Taking medication (except oral contraceptives)
- Pregnancy or breastfeeding
- Food intolerances or allergies to mushrooms and dairy products
- Smokers
- Visits to solariums or previous holidays in southern countries or in the Alps or other high mountains
Show all 10Show fewer
- Participation in another study
- Blood donation during the last 2 months before the start of the study
- Dieting
- Severe weight loss or weight loss (≥ 3 kg) within the last month
Trial locations and contacts
No sites are listed yet.
About this study
The European Food Safety Authority has approved many applications for UVB light treated foods (e.g. UVB-exposed button mushrooms) in the last years. The UVB light treatment is used to increase the vitamin D content in foods and improve the vitamin D status of subjects. However, UVB irradiation is accompanied by the formation of vitamin D photoisomers such as lumisterol and tachysterol. The current study aims to investigated whether these vitamin D photoisomers can enter the circulation and are metabolised in humans that consume UVB-treated mushrooms.
Read the detailed description
according to protocol
- Conditions
- Dietary Exposure, Safety Issues
- Being tested
- UVB-exposed button mushrooms
- Keywords
- lumisterol, tachysterol, hydroxy-photoisomers, vitamin D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UVB-exposed button mushroomsDietary supplement
Healthy subjects will be randomized into two groups and received either UVB-exposed button mushrooms or non-UVB-exposed button mushrooms for 7 days. Blood samples from each subject will be taken at baseline (before the intake of the mushrooms, 3 h and 6 h thereafter, and at day 8. Three months later, another blood sample was taken.
| Study group | Role | What they receive |
|---|---|---|
| oral intake of UVB-exposed mushrooms | Experimental | Daily intake of 500 g of UVB-exposed button mushrooms over 7 days (provided as mushroom cream soup) and blood sampling (at baseline, 3 h postprandial, 6 h postprandial and at day 8) Receives: Dietary Supplement: UVB-exposed button mushrooms |
| oral intake of non-UVB-exposed mushrooms | Placebo comparator | Daily intake of 500 g of non-UVB-exposed button mushrooms over 7 days (provided as mushroom cream soup) and blood sampling (at baseline, 3 h postprandial, 6 h postprandial and at day 8) Receives: Dietary Supplement: UVB-exposed button mushrooms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circulating vitamin D photoisomers
Plasma concentrations of vitamin D photoisomers (such as lumisterol, tachysterol and their hydroxy derivates) after the consumption of the UVB-exposed versus non UVB-exposed button mushrooms
Measured: at baseline (before the intervention), 3 hours postprandial, 6 hours postprandial, at day 8, changes from baseline at 3 months
Secondary outcomes (5)
Parameters of vitamin D metabolism
Plasma concentrations of vitamin D metabolites (vitamin D2, vitamin D3, 25-hydroxyvitamin D2, 25-hydroxyvitamin D3, 24,25-dihydroxyvitamin D2, calcitriol, ergosterol)
Measured: at baseline (before the intervention), 3 hours postprandial, 6 hours postprandial, at day 8, changes from baseline at 3 months
Parameters of mineral metabolism
Plasma calcium, phosphate, parathyroid hormone, fibroblast growth factor-23
Measured: at baseline (before the intervention), 3 hours postprandial, 6 hours postprandial, at day 8, changes from baseline at 3 months
Plasma lipids
Plasma triglycerides, cholesterol
Measured: at baseline (before the intervention), 3 hours postprandial, 6 hours postprandial, at day 8, changes from baseline at 3 months
Inflammation markers
Plasma CRP, Interleukin-6
Measured: at baseline (before the intervention), 3 hours postprandial, 6 hours postprandial, at day 8, changes from baseline at 3 months
mRNA and protein expression in peripheral mononuclear blood cells
Vitamin D receptor target genes, CYP enzymes
Measured: at baseline (before the intervention), 3 hours postprandial, 6 hours postprandial, at day 8, changes from baseline at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2022
- Study start9 Jan 2023 (estimated)
- Primary completion30 Jul 2023 (estimated)
- Study completion30 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary ExposureStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Martin-Luther-Universität Halle-Wittenberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriele Stangl, Martin-Luther-Universität Halle-Wittenberg
- Investigators
- Gabriele I Stangl, Prof. Dr., Principal investigator, Martin-Luther-Universität Halle-Wittenberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05668832
- Sponsor's protocol ID
- UHalle 2022-123
- Status last verified
- Dec 2022
- First submitted
- 15 Dec 2022
- Last updated
- 30 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability of Vitamin D Photoisomers From UVB-exposed Button Mushrooms
- ClinicalTrials.gov ID
- NCT05668832
- Acronym / sponsor ID
- UHalle 2022-123
- Conditions
- Dietary Exposure, Safety Issues
- Keywords
- lumisterol, tachysterol, hydroxy-photoisomers, vitamin D
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Martin-Luther-Universität Halle-WittenbergUniversity, hospital or other
- Study start
- 9 Jan 2023 (estimated)
- Primary completion
- 30 Jul 2023 (estimated)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 30 Dec 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 European Food Safety Authority has approved many applications for UVB light treated foods (e.g. UVB-exposed button mushrooms) in the last years. The UVB light treatment is used to increase the vitamin D content in foods and improve the vitamin D status of subjects. However, UVB irradiation is accompanied by the formation of vitamin D photoisomers such as lumisterol and tachysterol. The current study aims to investigated whether these vitamin D photoisomers can enter the circulation and are metabolised in humans that consume UVB-treated mushrooms.
Detailed description
according to protocol
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oral intake of UVB-exposed mushrooms | Experimental | Dietary Supplement: UVB-exposed button mushroomsDaily intake of 500 g of UVB-exposed button mushrooms over 7 days (provided as mushroom cream soup) and blood sampling (at baseline, 3 h postprandial, 6 h postprandial and at day 8) |
| oral intake of non-UVB-exposed mushrooms | Placebo comparator | Dietary Supplement: UVB-exposed button mushroomsDaily intake of 500 g of non-UVB-exposed button mushrooms over 7 days (provided as mushroom cream soup) and blood sampling (at baseline, 3 h postprandial, 6 h postprandial and at day 8) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy subjects
- Age between 18 and 65 years
- Body Mass Index in the range of 18.5 to 29.9 kg/m2
Key exclusion criteria (10 listed)
- Acute or chronic illnesses (high blood pressure, heart disease, diabetes, kidney disease, liver disease, alcohol dependence, etc.)
- Taking medication (except oral contraceptives)
- Pregnancy or breastfeeding
- Food intolerances or allergies to mushrooms and dairy products
- Smokers
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 |
|---|---|---|
| UVB-exposed button mushroomsHealthy subjects will be randomized into two groups and received either UVB-exposed button mushrooms or non-UVB-exposed button mushrooms for 7 days. Blood samples from each subject will be taken at baseline (before the intake of the mushrooms, 3 h and 6 h thereafter, and at day 8. Three months later, another blood sample was taken. | Dietary supplement | oral intake of UVB-exposed mushrooms, oral intake of non-UVB-exposed mushrooms |
Primary outcome
Circulating vitamin D photoisomers
Time frame: at baseline (before the intervention), 3 hours postprandial, 6 hours postprandial, at day 8, changes from baseline at 3 months
Plasma concentrations of vitamin D photoisomers (such as lumisterol, tachysterol and their hydroxy derivates) after the consumption of the UVB-exposed versus non UVB-exposed button mushrooms
5 secondary outcomes
Parameters of vitamin D metabolism
Time frame: at baseline (before the intervention), 3 hours postprandial, 6 hours postprandial, at day 8, changes from baseline at 3 months
Parameters of mineral metabolism
Time frame: at baseline (before the intervention), 3 hours postprandial, 6 hours postprandial, at day 8, changes from baseline at 3 months
Plasma lipids
Time frame: at baseline (before the intervention), 3 hours postprandial, 6 hours postprandial, at day 8, changes from baseline at 3 months
Inflammation markers
Time frame: at baseline (before the intervention), 3 hours postprandial, 6 hours postprandial, at day 8, changes from baseline at 3 months
mRNA and protein expression in peripheral mononuclear blood cells
Time frame: at baseline (before the intervention), 3 hours postprandial, 6 hours postprandial, at day 8, changes from baseline at 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2022.
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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.
Gabriele I Stangl, Prof. Dr. principal investigator
Martin-Luther-Universität Halle-Wittenberg
Questions about this trial
What is this clinical trial studying?
A study testing UVB-exposed button mushrooms in people with Dietary Exposure and Safety Issues, run by Martin-Luther-Universität Halle-Wittenberg.
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 3 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: status not confirmed, as of the sponsor's last update on 30 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gabriele I Stangl, Prof. Dr. (+493455522707, gabriele.stangl@landw.uni-halle.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Circulating vitamin D photoisomers (time frame: at baseline (before the intervention), 3 hours postprandial, 6 hours postprandial, at day 8, changes from baseline at 3 months). 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 30 Dec 2022.