Health Evaluation of Mushrooms withVitamin D2

NCT ID: NCT05716698

Last Updated: 2023-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-15

Study Completion Date

2022-06-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control Group

no Pleurotus citrinopileatus intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

D2 10ug Pleurotus citrinopileatus Group

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

Group Type EXPERIMENTAL

Pleurotus citrinopileatus after bio-optics (10 ug group)

Intervention Type DIETARY_SUPPLEMENT

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

D2 100ug Pleurotus citrinopileatus Group

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

Group Type EXPERIMENTAL

Pleurotus citrinopileatus after bio-optics (100 ug group)

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Pleurotus citrinopileatus after bio-optics (10 ug group)

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

Intervention Type DIETARY_SUPPLEMENT

Pleurotus citrinopileatus after bio-optics (100 ug group)

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Taipei Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chih-Han Lin, MS

Role: PRINCIPAL_INVESTIGATOR

Office of Human Research, Taipei Medical University

Locations

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Taipei Medical University

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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N202111054

Identifier Type: -

Identifier Source: org_study_id

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