UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063544 |
|---|---|
| Receipt number | R000072721 |
| Scientific Title | Effect of test food ingestion on suppressing core body temperature elevation during physical activity under heat stress |
| Date of disclosure of the study information | 2026/11/06 |
| Last modified on | 2026/11/06 15:00:48 |
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Basic information
Public title
Effect of test food ingestion on suppressing core body temperature elevation during physical activity under heat stress
Acronym
Effect of test food ingestion on suppressing core body temperature elevation during physical activity under heat stress
Scientific Title
Effect of test food ingestion on suppressing core body temperature elevation during physical activity under heat stress
Scientific Title:Acronym
Effect of test food ingestion on suppressing core body temperature elevation during physical activity under heat stress
Region
| Japan |
Condition
Condition
Healthy Subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of test food ingestion on suppressing core body temperature elevation and on subjective measures during physical activity in a hot environment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Core body temperature (rectal)
Key secondary outcomes
Body weight
Rating of Perceived Exertion (RPE)
Thermal sensation
Thermal comfort
Thirst sensation
Safety assessment
Blood test (White blood cell count, Red blood cell count, Hemoglobin, Hematocrit, Platelet count, Total protein, Albumin, Blood urea nitrogen, Creatinine, Creatine kinase, Total cholesterol, Triglycerides, LDL cholesterol, HDL cholesterol, Total bilirubin, Glucose, Hemoglobin A1c, Aspartate aminotransferase, Alanine aminotransferase, Lactate dehydrogenase, Gamma-glutamyl transferase, Alkaline phosphatase, Uric acid, Sodium, Calcium, Potassium, Serum osmolality)
Blood pressure measurement (Systolic blood pressure, Diastolic blood pressure)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Test product ingestion
Interventions/Control_2
Control product ingestion
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
| 18 | years-old | <= |
Age-upper limit
| 46 | years-old | > |
Gender
Male
Key inclusion criteria
Healthy males aged 18 to under 46 years at the time of consent, with no history of serious illness
Body mass index (BMI) between 18.5 and 25
Regular exercise habit of at least twice a week
Individuals capable of providing voluntary written informed consent after receiving sufficient explanation and fully understanding the purpose, procedures, expected benefits, and risks of the study
Key exclusion criteria
Individuals currently undergoing treatment for any disease, or with a history of serious diseases requiring medical treatment (e.g., cardiovascular, respiratory, or metabolic diseases)
Individuals with a history of severe heatstroke (Grade II or higher) diagnosed by a physician
Individuals previously diagnosed with vasovagal reflex by a physician
Individuals with a history of losing consciousness after exercise
Individuals with orthopedic complaints (e.g., low back pain, knee pain) or a history of trauma that would interfere with cycling exercise
Individuals routinely taking medications or supplements that affect thermoregulation, circulatory function, or metabolism
Current smokers
Individuals with skin diseases that would interfere with the attachment of measurement devices, or allergies to the materials used
Individuals deemed unsuitable for the study by the principal investigator or responsible physician due to health conditions, safety concerns, or other reasons
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Fuminori |
| Middle name | |
| Last name | Takayama |
Organization
EUPHORIA Co., Ltd.
Division name
Corporate Business Division
Zip code
102-0083
Address
10th Floor, Crystal City East Building, 4-8-1 Kojimachi, Chiyoda-ku, Tokyo, Japan
TEL
03-6388-9260
fuminori.takayama@eu-phoria.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Urushizawa |
Organization
EUPHORIA Co., Ltd.
Division name
Corporate Business Division
Zip code
102-0083
Address
10th Floor, Crystal City East Building, 4-8-1 Kojimachi, Chiyoda-ku, Tokyo, Japan
TEL
03-6388-9260
Homepage URL
yuki.urushizawa@eu-phoria.jp
Sponsor or person
Institute
EUPHORIA Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
ITOEN, 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
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
Tel
03-5408-1599
shiba_palace@s-palace-clinic.com
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 | 11 | Month | 06 | 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
| 2026 | Year | 10 | Month | 29 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 29 | Day |
Anticipated trial start date
| 2026 | Year | 11 | Month | 07 | Day |
Last follow-up date
| 2027 | 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
| 2026 | Year | 11 | Month | 06 | Day |
Last modified on
| 2026 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072721
