Health Evaluation of Mushrooms withVitamin D2

Sponsor
Taipei Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT05716698
Collaborator
(none)
36
1
3
1.5
23.3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Pleurotus citrinopileatus after bio-optics (10 ug group)
  • Dietary Supplement: Pleurotus citrinopileatus after bio-optics (100 ug group)
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Health Evaluation of Mushrooms withVitamin D2
Actual Study Start Date :
Apr 15, 2022
Actual Primary Completion Date :
Jun 1, 2022
Actual Study Completion Date :
Jun 1, 2022

Arms and Interventions

Arm Intervention/Treatment
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)
The participants took D2 10ug per day for a total of 4 weeks.

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

Outcome Measures

Primary Outcome Measures

  1. Change from baseline in 25OHD at week 4 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. Healthy human
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Taipei Medical University Taipei Taiwan

Sponsors and Collaborators

  • Taipei Medical University

Investigators

  • Principal Investigator: Chih-Han Lin, MS, Office of Human Research, Taipei Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Taipei Medical University
ClinicalTrials.gov Identifier:
NCT05716698
Other Study ID Numbers:
  • N202111054
First Posted:
Feb 8, 2023
Last Update Posted:
Feb 8, 2023
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Feb 8, 2023