Health Evaluation of Mushrooms withVitamin D2

Although Taiwan has plenty of sunshine, the intake of vitamin D and the concentration of 25(OH)D in the blood are low. Ingestion of mushrooms and extracts rich in D2 can increase the nutritional source of vitamin D. The purpose of this study is to evaluate the intake of D2 mushrooms and extracts in humans to achieve the effective concentration of 25(OH)D in the serum and recommendations for health improvement.

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Key information

Conditions

Healthy

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Medical University

Taipei, Taiwan

About this study

The subjects were divided into 3 groups: no mushroom intervention, intervention with D2 10ug Pleurotus citrinopileatus after bio-optics optimization (low dose group) or intervention with D2 100ug Pleurotus citrinopileatus after bio-optics optimization (high dose group). The low-dose group took D2 10ug per day, and the high-dose group received D2 100ug per day for a total of 4 weeks.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy human

Exclusion criteria

Any acute disease, such as infection, stroke, myocardial infarction or major surgery within three months, upper or lower gastrointestinal bleeding, blood pressure, and poor blood sugar control will be excluded.
Chronic diseases, such as malignant tumors, infection with human immunodeficiency virus (HIV) and related diseases, liver cirrhosis, or those with liver function exceeding 3 times the normal value (more than 120 IU/L), renal function (Cr) more than 2.5 mg /dl, chronic anemia (Hb <9 g/dl), metabolic diseases except diabetes (such as thyroid/parathyroid dysfunction), and those who have undergone abdominal surgery to cause intestinal sticking are excluded.
Women who are pregnant or breastfeeding will be excluded.
Those who use steroids, supplements with vitamin D-containing dietary supplements and hormones will be excluded.
Those with blood 25(OH)D concentration > 30 ng/ml will be excluded.
Those who are unwilling to fill out the consent form and refuse the questionnaire survey.

Treatment and study plan

Pleurotus citrinopileatus after bio-optics (10 ug group)

Dietary Supplement

The participants took D2 10ug per day for a total of 4 weeks.

Pleurotus citrinopileatus after bio-optics (100 ug group)

Dietary Supplement

The participants took D2 100ug per day for a total of 4 weeks.

Primary outcomes

Change from baseline in 25OHD at week 4

Time frame: Baseline and week 4

The participants' blood was taken to analyze the concentration of 25OHD to compare the changes between baseline and 4 weeks later. 25OHD concentration standard is:

25OHD < 20 ng/ml: deficiency 20 ng/ml < 25OHD < 30 ng/ml: Insufficiency 25OHD > 30 ng/ml: Normal

Sponsors and collaborators

Lead sponsor

Taipei Medical University

Other

Registry information

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2022
First posted: Feb 8, 2023
Registry last updated: Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed