Bioavailability of Vitamin D Photoisomers From UVB-exposed Button Mushrooms

Safety Issues Clinical Trial

Official title:

Bioavailability of Vitamin D Photoisomers From UVB-exposed Button Mushrooms

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05668832
• Other study ID #: UHalle 2022-123
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 9, 2023
• Est. completion date: July 30, 2024

Study information

• Verified date: December 2022
• Source: Martin-Luther-Universität Halle-Wittenberg
• Contact: Gabriele I Stangl, Prof. Dr.
• Phone: +493455522707
• Email: gabriele.stangl[@]landw.uni-halle.de
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Description:

according to protocol

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: July 30, 2024
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Dietary Exposure
• Safety Issues

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Martin-Luther-Universität Halle-Wittenberg

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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