Health Evaluation of Mushrooms withVitamin D2

NCT05716698 | Completed

• 1 other identifier: N202111054
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

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

  Baseline and week 4

Study Arms (3)

Control Group

NO INTERVENTION

no Pleurotus citrinopileatus intervention

D2 10ug Pleurotus citrinopileatus Group

EXPERIMENTAL

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

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

D2 100ug Pleurotus citrinopileatus Group

EXPERIMENTAL

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

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

Interventions

Pleurotus citrinopileatus after bio-optics (10 ug group) DIETARY_SUPPLEMENT

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

D2 10ug Pleurotus citrinopileatus Group

Pleurotus citrinopileatus after bio-optics (100 ug group) DIETARY_SUPPLEMENT

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

D2 100ug Pleurotus citrinopileatus Group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. Healthy human

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (1)

Taipei Medical University

Taipei, Taiwan

Location

MeSH Terms

Interventions

Population Groups

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Chih-Han Lin, MS

  Office of Human Research, Taipei Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: February 8, 2023
• Study Start: April 15, 2022
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: February 8, 2023

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)