Bioavailability of Vitamin D Photoisomers From UVB-exposed Button Mushrooms

Study Overview
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Brief Summary
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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
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according to protocol

Official Title
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Bioavailability of Vitamin D Photoisomers From UVB-exposed Button Mushrooms

Conditions
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Dietary Exposure, Safety Issues

Intervention / Treatment
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* Dietary Supplement: UVB-exposed button mushrooms


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: oral intake of UVB-exposed mushrooms<br>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) | Dietary Supplement: UVB-exposed button mushrooms<br>* 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.<br>|
| Placebo Comparator: oral intake of non-UVB-exposed mushrooms<br>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) | Dietary Supplement: UVB-exposed button mushrooms<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | at baseline (before the intervention), 3 hours postprandial, 6 hours postprandial, at day 8, changes from baseline at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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 | 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 | 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 | 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 | at baseline (before the intervention), 3 hours postprandial, 6 hours postprandial, at day 8, changes from baseline at 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lumisterol, tachysterol, hydroxy-photoisomers, vitamin D