UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060293 |
|---|---|
| Receipt number | R000068971 |
| Scientific Title | Health and Productivity Management program " #Watashi no kinkatsu" : Verification of effects on the gut environment and subjective health by mushroom consumption among employees |
| Date of disclosure of the study information | 2026/01/08 |
| Last modified on | 2026/01/08 11:13:16 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Health and Productivity Management program " #Watashi no kinkatsu" : Verification of effects on the gut environment and subjective health by mushroom consumption among employees
Acronym
Health and Productivity Management program " #Watashi no kinkatsu" : Verification of effects on the gut environment and subjective health by mushroom consumption among employees
Scientific Title
Health and Productivity Management program " #Watashi no kinkatsu" : Verification of effects on the gut environment and subjective health by mushroom consumption among employees
Scientific Title:Acronym
Health and Productivity Management program " #Watashi no kinkatsu" : Verification of effects on the gut environment and subjective health by mushroom consumption among employees
Region
| Japan |
Condition
Condition
Healthy male/female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
As part of our health and productivity management, we will provide employees with opportunities to consume mushrooms and examine the effects of mushroom consumption on fecal short-chain fatty acid levels and various health-related indicators.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fecal metabolites (short-chain fatty acids and organic acids)
Key secondary outcomes
1Defecation status (the number of days, frequency, property, feeling of incomplete evacuation, abdominal pain)
2Presenteeism
3Subjective health status
4Body weight
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingestion of mushrooms at 40 g per day for 4 weeks.
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Male or female employees of HOKUTO Group (HOKUTO Corporation or Hokuto Industry Corporation) who are aged 20 years or older at the time of informed consent.
(2) Subjects who receive explanation about the study, are able to understand the contents, and provide written informed consent by themselves.
Key exclusion criteria
(1) Individuals who have taken medications that may affect the gut environment (e.g., antibiotics, intestinal regulators, laxatives) within 1 month prior to starting intake of the test food, or who cannot restrict such use during the study. Use for hay fever is permitted.
(2) Individuals who are currently participating in another clinical trial of drugs or health foods, within 4 weeks after completing another trial, or who plan to participate in another clinical trial after consenting to this study.
(3) Individuals with excessive alcohol consumption.
(4) Individuals who have undergone surgery within 6 months prior to consent that may affect the study (e.g., colorectal endoscopic surgery, cholecystectomy for gallstones, gastric bypass).
(5) Individuals with a history or current serious disease of the heart, liver, kidneys, or gastrointestinal tract.
(6) Individuals who are pregnant, breastfeeding, or intend to become pregnant during the study period.
(7) Individuals with a mushroom allergy or who cannot tolerate mushrooms.
(8) Individuals judged by the principal investigator to be unsuitable for participation in this study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Nishizawa |
Organization
HOKUTO Corporation
Division name
Human Resources Department
Zip code
381-8533
Address
138-1 Minamihori, Nagano-shi, Nagano ,381-8533 , Japan
TEL
026-259-5955
jinji@hokto-kinoko.co.jp
Public contact
Name of contact person
| 1st name | Nanako |
| Middle name | |
| Last name | Sugawara |
Organization
HOKUTO Corporation
Division name
R & D
Zip code
381-0008
Address
Mushroom Research Laboratory 800-8 Oaza-Shimokomazawa, Nagano-shi, Nagano 381-0008, Japan
TEL
026-296-3211
Homepage URL
nanako.ishiyama@hokto-kinoko.co.jp
Sponsor or person
Institute
HOKUTO Corporation
Institute
Department
Personal name
Funding Source
Organization
HOKUTO Corporation
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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
Tel
+81-3-5297-5548
IRB@cpcc.co.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
| 2026 | Year | 01 | Month | 08 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 12 | Month | 19 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 19 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 30 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 01 | Month | 08 | Day |
Last modified on
| 2026 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068971
