Clinical trial NCT05668832: Bioavailability of Vitamin D Photoisomers From UVB-exposed Button Mushrooms
Official title: Bioavailability of Vitamin D Photoisomers From UVB-exposed Button Mushrooms
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dietary Exposure
Safety Issues
Keywords: lumisterol
tachysterol
hydroxy-photoisomers
vitamin D
Lead sponsor: Martin-Luther-Universität Halle-Wittenberg
Sponsor class: OTHER
First posted: 2022-12-30
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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

Eligibility criteria: Inclusion Criteria:

* Healthy subjects
* Age between 18 and 65 years
* Body Mass Index in the range of 18.5 to 29.9 kg/m2

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Circulating vitamin D photoisomers
timeFrame: at baseline (before the intervention), 3 hours postprandial, 6 hours postprandial, at day 8, changes from baseline at 3 months
Secondary outcomes:
measure: Parameters of vitamin D metabolism
timeFrame: at baseline (before the intervention), 3 hours postprandial, 6 hours postprandial, at day 8, changes from baseline at 3 months
measure: Parameters of mineral metabolism
timeFrame: at baseline (before the intervention), 3 hours postprandial, 6 hours postprandial, at day 8, changes from baseline at 3 months
measure: Plasma lipids
timeFrame: at baseline (before the intervention), 3 hours postprandial, 6 hours postprandial, at day 8, changes from baseline at 3 months
measure: Inflammation markers
timeFrame: at baseline (before the intervention), 3 hours postprandial, 6 hours postprandial, at day 8, changes from baseline at 3 months
measure: mRNA and protein expression in peripheral mononuclear blood cells
timeFrame: at baseline (before the intervention), 3 hours postprandial, 6 hours postprandial, at day 8, changes from baseline at 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Martin-Luther-Universität Halle-Wittenberg
name: Gabriele I Stangl, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: