UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058021 |
|---|---|
| Receipt number | R000066159 |
| Scientific Title | Evaluation of the Effects of Outdoor-Cultivated Agaricus brasiliensis KA21 on Quality of Life in Middle-Aged and Elderly Men |
| Date of disclosure of the study information | 2025/05/30 |
| Last modified on | 2025/05/30 07:53:56 |
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Basic information
Public title
Evaluation of the Effects of Outdoor-Cultivated Agaricus brasiliensis KA21 on Quality of Life in Middle-Aged and Elderly Men
Acronym
Evaluation of the Effects of Outdoor-Cultivated Agaricus brasiliensis KA21 on Quality of Life in Middle-Aged and Elderly Men
Scientific Title
Evaluation of the Effects of Outdoor-Cultivated Agaricus brasiliensis KA21 on Quality of Life in Middle-Aged and Elderly Men
Scientific Title:Acronym
Evaluation of the Effects of Outdoor-Cultivated Agaricus brasiliensis KA21 on Quality of Life in Middle-Aged and Elderly Men
Region
| Japan |
Condition
Condition
Middle-Aged and Elderly Men
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study evaluates the effects of an 8 week continuous intake of outdoor cultivated Agaricus brasiliensis KA21 on quality of life, (QOL) specific to middle and elderly men.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Questions Regarding the Quality of Life (QOL) and Performance of Middle-Aged and Elderly Men
Key secondary outcomes
The Aging Males' Symptoms (AMS) scale, Erection Hardness Score (EHS), International Prostate Symptom Score (IPSS), Overactive Bladder Symptom Score (OABSS), blood cortisol and testosterone levels, mental state evaluation via voice analysis, and others.
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Consume 800mg of the test food every day for 8 weeks.
Interventions/Control_2
Consume placebo every day for 8 weeks.
Interventions/Control_3
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
| 40 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male
Key inclusion criteria
Men aged 40 years or older at the time of consent, with mild, moderate, or severe scores on the Aging Males' Symptoms (AMS) scale.
Key exclusion criteria
1)Subjects who are regularly consuming food or supplement containing beta-glucan which is the active ingredient of test food.
2)Subjects under treatment which would affects the trial results.
3)Subjects who do not carry out the inspection including collecting blood samples under the test rule.
4)Subjects who would be allergic to test foods.
5)Others who have been determined ineligible by principal investigator or cooperating institution.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hirobumi |
| Middle name | |
| Last name | Tada |
Organization
Shigakkan University
Division name
Department of Nutrition, Faculty of Wellness
Zip code
474-8651
Address
55 Nakoyama, Yokonemachi, Obu, Aichi 474-8651, Japan
TEL
+81-562-46-1291
tada@sgk.ac.jp
Public contact
Name of contact person
| 1st name | Akitomo |
| Middle name | |
| Last name | Motoi |
Organization
Toei Shinyaku Co.,Ltd.
Division name
President
Zip code
181-0013
Address
1-11-23 Shimorenjaku, Mitaka, Tokyo, Japan
TEL
+81-422-26-7310
Homepage URL
akitomo-motoi@toeishinyaku.com
Sponsor or person
Institute
Shigakkan University
Institute
Department
Personal name
Funding Source
Organization
Toei Shinyaku Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
1)Toei Shinyaku Co.,Ltd.
2)RAICA CO.,LTD
3)eHealth clinic Shinjuku
4)SHIN4NY Inc.
5)D Clinic Shinjyuku
6)National Center for Geriatrics and Gerontology
7)Gloo LynQ Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shigakkan University Research Ethics Review Committee
Address
55 Nakoyama, Yokonemachi, Obu, Aichi 474-8651, Japan
Tel
+81-562-46-1291
grant@sgk.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
304
Org. issuing International ID_1
Shigakkan University Research Ethics Review Committee
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 | 05 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 04 | Month | 07 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 05 | Month | 30 | Day |
Last modified on
| 2025 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066159
