Bioavailability of Vitamin D Photoisomers From UVB-exposed Button Mushrooms

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Safety Issues; Dietary Exposure
• Intervention / Treatment: Dietary supplement: UVB-exposed button mushrooms

Detailed Description

according to protocol

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gabriele I Stangl, Prof. Dr.; Phone Number: +493455522707; Email: gabriele.stangl@landw.uni-halle.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: oral intake of UVB-exposed 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)	Dietary supplement: UVB-exposed button mushrooms; 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.
Placebo Comparator: oral intake of non-UVB-exposed 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)	Dietary supplement: UVB-exposed button mushrooms; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Martin-Luther-Universität Halle-Wittenberg
• Investigators: Principal Investigator: Gabriele I Stangl, Prof. Dr., Martin-Luther-Universität Halle-Wittenberg

Study record dates

Study Major Dates

• Study Start (Anticipated): January 9, 2023
• Primary Completion (Anticipated): July 30, 2023
• Study Completion (Anticipated): July 30, 2024

Study Registration Dates

• First Submitted: December 15, 2022
• First Submitted That Met QC Criteria: December 24, 2022
• First Posted (Actual): December 30, 2022

Study Record Updates

• Last Update Posted (Actual): December 30, 2022
• Last Update Submitted That Met QC Criteria: December 24, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: vitamin D; lumisterol; tachysterol; hydroxy-photoisomers
• Other Study ID Numbers: UHalle 2022-123

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No