Bioavailability of Vitamin D Photoisomers From UVB-exposed Button Mushrooms

Martin-Luther-Universität Halle-Wittenberg

Status: Not yet enrolling

Conditions: Dietary Exposure; Safety Issues

Treatments: Dietary Supplement: UVB-exposed button mushrooms

Study type: Interventional

Funder types: Other

Identifiers

NCT05668832

UHalle 2022-123

Details and patient eligibility

About

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.

Full description

according to protocol

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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36 participants in 2 patient groups, including a placebo group

oral intake of UVB-exposed mushrooms

Experimental group

Description:

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)

Treatment:

Dietary Supplement: UVB-exposed button mushrooms

oral intake of non-UVB-exposed mushrooms

Placebo Comparator group

Description:

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)

Treatment:

Dietary Supplement: UVB-exposed button mushrooms