UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060200 |
|---|---|
| Receipt number | R000068718 |
| Scientific Title | A randomized, double-blind, placebo-controlled, parallel-group comparative study to examine the effect of test food intake on heat acclimation |
| Date of disclosure of the study information | 2025/12/25 |
| Last modified on | 2025/12/25 12:27:24 |
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Basic information
Public title
A randomized, double-blind, placebo-controlled, parallel-group comparative study to examine the effect of test food intake on heat acclimation
Acronym
The effect of test food on heat acclimation
Scientific Title
A randomized, double-blind, placebo-controlled, parallel-group comparative study to examine the effect of test food intake on heat acclimation
Scientific Title:Acronym
The effect of test food on heat acclimation
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to verify whether combining exercise in a cool environment, a warm bath after exercise, and the intake of test food post-exercise can effectively enhance heat tolerance.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Results of the heat tolerance test (degree of increase in core temperature), blood volume, and blood albumin content.
Key secondary outcomes
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
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of test food for two weeks
Interventions/Control_2
Intake of placebo for two 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
| 45 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male
Key inclusion criteria
1. Healthy individuals
2. Males
3. Individuals aged 45 to 64 years at the time of consent
4. Individuals who have not participated in a regular exercise training program within the two years prior to the start of the study
5. Individuals who are able to participate in the study as specified, including exercise, hot baths, and blood sampling at the research facility
6. Individuals who have received a thorough explanation of the study and, after fully understanding it, have given their voluntary written consent
Key exclusion criteria
1. Smokers
2. Obese individuals (body mass index 30 kg/m2 or higher)
3. Individuals with abnormalities requiring exercise restriction in a health checkup within the past year
4. Individuals who have been advised by a doctor not to engage in strenuous exercise
5. Individuals with allergies to test foods (soy or milk)
6. Individuals deemed inappropriate for participation by the research co-investigator (physician)
7. Individuals who answer "yes" to at least one of the seven questions on the physical activity risk screening sheet
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | Kazunobu |
| Middle name | |
| Last name | Okazaki |
Organization
Osaka Metropolitan University
Division name
Center for Health Science Innovation
Zip code
558-8585
Address
3-3-138 Sugimoto, Sumiyoshi, Osaka, Japan
TEL
06-6605-2905
gr-knky-chsi@omu.ac.jp
Public contact
Name of contact person
| 1st name | Kazunobu |
| Middle name | |
| Last name | Okazaki |
Organization
Osaka Metropolitan University
Division name
Center for Health Science Innovation
Zip code
558-8585
Address
3-3-138 Sugimoto, Sumiyoshi, Osaka, Japan
TEL
06-6605-2905
Homepage URL
gr-knky-chsi@omu.ac.jp
Sponsor or person
Institute
Osaka Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical 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
Ethics Committee, Center for Health Science Innovation
Address
3-3-138 Sugimoto, Sumiyoshi, Osaka, Japan
Tel
06-6605-2905
gr-knky-chsi@omu.ac.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 | 12 | Month | 25 | 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
Suspended
Date of protocol fixation
| 2025 | Year | 08 | Month | 04 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 06 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 22 | Day |
Last follow-up date
| 2026 | Year | 03 | 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 | 12 | Month | 25 | Day |
Last modified on
| 2025 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068718
