Bioavailability of Vitamin D Photoisomers From UVB-exposed Button Mushrooms

NCT05668832 | Unknown

• 1 other identifier: UHalle 2022-123
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dietary Exposure; Safety Issues

Keywords

lumisterol; tachysterol; hydroxy-photoisomers; vitamin D

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• 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 lipids

  at baseline (before the intervention), 3 hours postprandial, 6 hours postprandial, at day 8, changes from baseline at 3 months

• Inflammation markers

  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

  at baseline (before the intervention), 3 hours postprandial, 6 hours postprandial, at day 8, changes from baseline at 3 months

Study Arms (2)

oral intake of UVB-exposed mushrooms

EXPERIMENTAL

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

oral intake of non-UVB-exposed mushrooms

PLACEBO COMPARATOR

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

Interventions

UVB-exposed button mushrooms DIETARY_SUPPLEMENT

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.

oral intake of UVB-exposed mushrooms; oral intake of non-UVB-exposed mushrooms

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Martin-Luther-Universität Halle-Wittenberg: lead

Study Officials

• Gabriele I Stangl, Prof. Dr.

  Martin-Luther-Universität Halle-Wittenberg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriele I Stangl, Prof. Dr.

CONTACT

+493455522707; gabriele.stangl@landw.uni-halle.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: December 15, 2022
• First Posted: December 30, 2022
• Study Start: January 9, 2023
• Primary Completion: July 30, 2023
• Study Completion: July 30, 2024
• Last Updated: December 30, 2022

Record last verified: 2022-12