UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050636 |
|---|---|
| Receipt number | R000057679 |
| Scientific Title | The effect of long-term intake of Maitake (Grifola frondosa) on human health |
| Date of disclosure of the study information | 2025/04/11 |
| Last modified on | 2026/03/20 13:03:33 |
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Basic information
Public title
The effect of long-term intake of Maitake (Grifola frondosa) on human health
Acronym
The effect of long-term intake of Maitake (Grifola frondosa) on human health
Scientific Title
The effect of long-term intake of Maitake (Grifola frondosa) on human health
Scientific Title:Acronym
The effect of long-term intake of Maitake (Grifola frondosa) on human health
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of test-food intake on healthy adults
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Complete blood count
Key secondary outcomes
General items of blood biochemistry
Blood properties including various metaboric markaers
Body size
Muscle strength
Emotion
Cognitive function
Immune regulation
Physical condition
Defecation status
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Consumption of the test food (containing maitakeA) to subject for 12 or 18 weeks
Interventions/Control_2
Consumption of the test food (containing maitakeB) to subject for 12 or 18 weeks
Interventions/Control_3
Consumption of the test food (placebo) to subject for 12 or 18 weeks
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Subjects who aged from 40 to 85 or 18 to 25, when giving the informed consent.
2)Subjects who do not have diseases which would affect trial results.
3)Subjects who agree to participate in the current with written informed consent.
4)Subjects who can speak Japanese.
Key exclusion criteria
1)Subgects who are pregnant.
2)Subjects who undergoing treatment for dementia, osteoporosis, liver disorder, kidney disorder and/or malignant tumor.
3)Subjects whose fasting serum triglyceride is >=199mg/dl.
4)Subjects who take steroids and/or immunosuppressant.
5)Subjects who regularly take muscle enhancers under the direction of a doctor.
6)Subjects who regularly take intestinal regulators under the direction of a doctor.
7)Subjects who have allergy of maitake.
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Shuzo |
| Middle name | |
| Last name | Ohata |
Organization
Kato Hospital, Jinjukai Healthcare Corporation
Division name
Kato Hospital, Jinjukai Healthcare Corporation
Zip code
6960001
Address
Kawamoto383-1, Shimane, Japan
TEL
0855720640
info@k-jinju.or.jp
Public contact
Name of contact person
| 1st name | Nohara |
| Middle name | |
| Last name | Takahashi |
Organization
Kato Hospital, Jinjukai Healthcare Corporation
Division name
General Affairs Division
Zip code
6960001
Address
Kawamoto383-1, Shimane, Japan
TEL
0855720640
Homepage URL
info@k-jinju.or.jp
Sponsor or person
Institute
Kato Hospital, Jinjukai Healthcare Corporation
Institute
Department
Personal name
Funding Source
Organization
YUKIGUNI MAITAKE CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kato Hospital, Jinjukai Healthcare Corporation
Address
Kawamoto383-1, Shimane, Japan
Tel
0855720640
info@k-jinju.or.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
171
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2022 | Year | 09 | Month | 26 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 02 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 03 | Month | 20 | Day |
Last modified on
| 2026 | Year | 03 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057679
