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CompletedNCT05716698Updated Feb 8, 2023

Health Evaluation of Mushrooms withVitamin D2

An interventional study of Pleurotus citrinopileatus after bio-optics (10 ug group) and Pleurotus citrinopileatus after bio-optics (100 ug group) in Healthy, sponsored by Taipei Medical University. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-08.

Sponsored by Taipei Medical University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Apr 2022, registered Jan 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Taipei Medical University is the lead sponsor of 245 studies on the registry; 56 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Healthy human

Exclusion criteria

Exclusion Criteria:

  1. 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.
  2. 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.
  3. Women who are pregnant or breastfeeding will be excluded.
  4. Those who use steroids, supplements with vitamin D-containing dietary supplements and hormones will be excluded.
  5. Those with blood 25(OH)D concentration > 30 ng/ml will be excluded.
  6. Those who are unwilling to fill out the consent form and refuse the questionnaire survey.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • No intervention
    Control Group

    no Pleurotus citrinopileatus intervention

  • Experimental
    D2 10ug Pleurotus citrinopileatus Group

    took D2 10ug Pleurotus citrinopileatus per day for a total of 4 weeks.

    Dietary Supplement: Pleurotus citrinopileatus after bio-optics (10 ug group)

  • Experimental
    D2 100ug Pleurotus citrinopileatus Group

    took D2 100ug Pleurotus citrinopileatus per day for a total of 4 weeks.

    Dietary Supplement: Pleurotus citrinopileatus after bio-optics (100 ug group)

Interventions

  • Dietary supplementPleurotus citrinopileatus after bio-optics (10 ug group)

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

  • Dietary supplementPleurotus citrinopileatus after bio-optics (100 ug group)

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

06

What researchers measure

Primary outcomes

  1. Change from baseline in 25OHD at 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

    Time frame: Baseline and week 4

07

Study locations

1 site
  • Taipei Medical University
    Taipei, Taiwan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05716698
Lead sponsor
Taipei Medical University
Responsible party
Sponsor
First posted
Feb 8, 2023
Start date
Apr 15, 2022
Primary completion
Jun 1, 2022
Completion
Jun 1, 2022
Last update
Feb 8, 2023

Study contacts

Chih-Han Lin, MS
principal investigator · Office of Human Research, Taipei Medical University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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