UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058479 |
|---|---|
| Receipt number | R000066848 |
| Scientific Title | Evaluation of the effect of ingesting test food on reducing heat stress |
| Date of disclosure of the study information | 2025/07/15 |
| Last modified on | 2025/07/15 14:18:05 |
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Basic information
Public title
Evaluation of the effect of ingesting test food on reducing heat stress
Acronym
Evaluation of the effect of ingesting test food on reducing heat stress
Scientific Title
Evaluation of the effect of ingesting test food on reducing heat stress
Scientific Title:Acronym
Evaluation of the effect of ingesting test food on reducing heat stress
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluating the effect of ingesting the test food for 15 to 20 days on heat stress indexes
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Core body temperature
Key secondary outcomes
Questionnaire
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
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingesting the test food for 15 to 20 days, followed by a washout period and then the placebo food for 15 to 20 days.
Interventions/Control_2
Ingesting the placebo food for 15 to 20 days, followed by a washout period and then the test food for 15 to 20 days.
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
| 65 | years-old | > |
Gender
Male
Key inclusion criteria
1) Men aged 20 to 65 at the time of obtaining consent
2) Participants who are exposed to heat stress in their daily work
Key exclusion criteria
1) Participants who have abnormalities in their regular health checkup results and are deemed unsuitable for participation in the study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Eiji |
| Middle name | |
| Last name | Yuasa |
Organization
Karada Lab, Inc. (Arkray Group)
Division name
Product Development Team
Zip code
601-8046
Address
8 nishiyama-cho, Higashi-kujo, Minami-ku, Kyoto, JAPAN
TEL
050-5830-1040
yuasa.al@arkray.co.jp
Public contact
Name of contact person
| 1st name | Eiji |
| Middle name | |
| Last name | Yuasa |
Organization
Karada Lab, Inc. (Arkray Group)
Division name
Product Development Team
Zip code
601-8046
Address
8 nishiyama-cho, Higashi-kujo, Minami-ku, Kyoto, JAPAN
TEL
050-5830-1040
Homepage URL
yuasa.al@arkray.co.jp
Sponsor or person
Institute
Karada Lab, Inc. (Arkray Group)
Institute
Department
Personal name
Eiji Yuasa
Funding Source
Organization
Karada Lab, Inc. (Arkray Group)
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
Ethics Review Committee of the ARKRAY,Inc.
Address
Yousuien-nai, 59 Gansuin-cho, Kamigyo-ku, Kyoto, JAPAN
Tel
050-5527-9303
kachitori@arkray.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
| 2025 | Year | 07 | Month | 15 | 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 | 06 | Month | 27 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 15 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 16 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 17 | Day |
Date of closure to data entry
| 2025 | Year | 09 | Month | 22 | Day |
Date trial data considered complete
| 2025 | Year | 09 | Month | 26 | Day |
Date analysis concluded
| 2025 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 07 | Month | 15 | Day |
Last modified on
| 2025 | Year | 07 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066848
