Health Evaluation of Mushrooms withVitamin D2

January 28, 2023 updated by: Taipei Medical University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Taipei Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline and week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 15, 2022

Primary Completion (ACTUAL)

June 1, 2022

Study Completion (ACTUAL)

June 1, 2022

Study Registration Dates

First Submitted

January 9, 2023

First Submitted That Met QC Criteria

January 28, 2023

First Posted (ACTUAL)

February 8, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

January 28, 2023

Last Verified

February 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • N202111054

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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