Bioavailability of Vitamin D Photoisomers From UVB-exposed Button Mushrooms

Not Applicable

Not yet recruiting

• Conditions: Dietary Exposure; Safety Issues
• Interventions: Dietary Supplement: UVB-exposed button mushrooms

• Registration Number: NCT05668832
• Lead Sponsor: Martin-Luther-Universität Halle-Wittenberg

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

Study Timeline

• Status Verified: 2022-12
• Study First Submitted: 2022-12-15
• Study First Submitted QC: 2022-12-24
• Last Update Submitted: 2022-12-24
• Study First Posted: 2022-12-30
• Last Update Posted: 2022-12-30
• Study Start: 2023-01-09
• Primary Completion: 2023-07-30
• Study Completion: 2024-07-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
oral intake of UVB-exposed mushrooms	UVB-exposed button mushrooms	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)
oral intake of non-UVB-exposed mushrooms	UVB-exposed button mushrooms	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)

Primary Outcome Measures

Name	Time	Method
Circulating vitamin D photoisomers	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

Secondary Outcome Measures

Name	Time	Method
Plasma lipids	at baseline (before the intervention), 3 hours postprandial, 6 hours postprandial, at day 8, changes from baseline at 3 months	Plasma triglycerides, cholesterol
Inflammation markers	at baseline (before the intervention), 3 hours postprandial, 6 hours postprandial, at day 8, changes from baseline at 3 months	Plasma CRP, Interleukin-6
mRNA and protein expression in peripheral mononuclear blood cells	at baseline (before the intervention), 3 hours postprandial, 6 hours postprandial, at day 8, changes from baseline at 3 months	Vitamin D receptor target genes, CYP enzymes
Parameters of vitamin D metabolism	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 metabolites (vitamin D2, vitamin D3, 25-hydroxyvitamin D2, 25-hydroxyvitamin D3, 24,25-dihydroxyvitamin D2, calcitriol, ergosterol)
Parameters of mineral metabolism	at baseline (before the intervention), 3 hours postprandial, 6 hours postprandial, at day 8, changes from baseline at 3 months	Plasma calcium, phosphate, parathyroid hormone, fibroblast growth factor-23