UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062993 |
|---|---|
| Receipt number | R000072114 |
| Scientific Title | Effects of Chilled Food Ingestion on Physiological Strain and Subjective Perceptions during Walking Exercise in the Heat: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/10/02 |
| Last modified on | 2026/09/19 13:14:13 |
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Basic information
Public title
Effects of Chilled Food Ingestion on Physiological Strain and Subjective Perceptions during Walking Exercise in the Heat: A Randomized Controlled Trial
Acronym
Effects of Chilled Food Ingestion on Physiological Strain and Subjective Perceptions during Walking Exercise in the Heat: A Randomized Controlled Trial
Scientific Title
Effects of Chilled Food Ingestion on Physiological Strain and Subjective Perceptions during Walking Exercise in the Heat: A Randomized Controlled Trial
Scientific Title:Acronym
Effects of Chilled Food Ingestion on Physiological Strain and Subjective Perceptions during Walking Exercise in the Heat: A Randomized Controlled Trial
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to investigate and compare the effects of ingesting chilled solid food versus fluid controls before exercise and during mid-exercise rest on core gastrointestinal temperature, physiological responses (heart rate and blood pressure), and subjective perceptual ratings (thermal sensation, thermal comfort, perceived exertion, and gastrointestinal distress) during intermittent walking exercise under hot environmental conditions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gastrointestinal core body temperature (Baseline value, mean value during each walking bout, peak value, maximum change from baseline, and cumulative thermal area under the curve across the experimental protocol)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
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
Ingestion of chilled solid food before exercise and during mid-exercise rest.
Interventions/Control_2
Drink cold water before exercise and during rest periods between exercises.
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
| 35 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy adult males aged 18 to 35 years
Individuals with regular exercise habits and sufficient fitness to safely complete 90 minutes of walking in the heat
Individuals who provide written (online) informed consent
Key exclusion criteria
History or presence of cardiac, renal, or gastrointestinal diseases
History of severe heat illness Known allergy to test foods or ingredients
Regular use of medications affecting thermoregulation, hydration status, or metabolism
Deemed unsuitable by the principal investigator
Target sample size
21
Research contact person
Name of lead principal investigator
| 1st name | Yosuke |
| Middle name | |
| Last name | Nagashima |
Organization
Musashigaoka Junior College
Division name
Department of Health and Nutrition, Course of Health and Nutrition
Zip code
355-0154
Address
111-1 Minami-Yoshimi, Yoshimi-machi, Hiki-gun, Saitama, Japan
TEL
0493545101
nagashima-y@musashigaoka.ac.jp
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Nagashima |
Organization
Musashigaoka Junior College
Division name
Department of Health and Life Sciences
Zip code
3550037
Address
111-1, Minami Yoshimi, Yoshimi-Town, Hiki-Gun, Saitama
TEL
09048177121
Homepage URL
nagashima-y@musashigaoka.ac.jp
Sponsor or person
Institute
Musashigaoka Junior College
Institute
Department
Personal name
Funding Source
Organization
Akagi Nyugyo 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
Musashigaoka Junior College
Address
111-1, Minami Yoshimi, Yoshimi-Town, Hiki-Gun, Saitama Pref.
Tel
0493545101
info@musashigaoka.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
| 2026 | Year | 10 | Month | 02 | 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 | 09 | Month | 04 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 14 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 20 | Day |
Last follow-up date
| 2028 | 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
| 2026 | Year | 09 | Month | 19 | Day |
Last modified on
| 2026 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072114
