UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062691 |
|---|---|
| Receipt number | R000071777 |
| Scientific Title | Effects of Ingesting Electrolyte-Containing Food on Physiological Strain and Conditioning in the Heat: A Randomized, Double-Blind, Parallel-Group Trial |
| Date of disclosure of the study information | 2026/08/26 |
| Last modified on | 2026/08/26 04:48:15 |
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Basic information
Public title
Effects of Ingesting Electrolyte-Containing Food on Physiological Strain and Conditioning in the Heat: A Randomized, Double-Blind, Parallel-Group Trial
Acronym
Ingesting Electrolyte Food in the Heat
Scientific Title
Effects of Ingesting Electrolyte-Containing Food on Physiological Strain and Conditioning in the Heat: A Randomized, Double-Blind, Parallel-Group Trial
Scientific Title:Acronym
E-FOOD Trial
Region
| Japan |
Condition
Condition
Healthy volunteers under heat stress
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the effects of ingesting electrolyte-containing food in combination with fluid intake on core body temperature elevation, dehydration rate, and subjective conditioning during prolonged exercise in the heat. Through this randomized controlled trial, we evaluate effective nutritional supplementation strategies for reducing physiological strain and preventing heat-related disorders during physical activity under heat stress.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Core body temperature responses
Monitored using a telemetric temperature sensor from pre- to post-exercise, evaluating the mean value, peak value, and changes from baseline throughout the exercise session.
Percentage of body mass loss (Dehydration rate)
Evaluated by calculating the percentage of body mass loss based on body mass measurements taken before and immediately after the exercise protocol.
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
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingestion of an electrolyte-containing food containing sodium, potassium, calcium, magnesium, and carbohydrates along with regular water intake at scheduled intervals during an exercise protocol under heat stress.
Interventions/Control_2
Ingestion of a placebo food (matched in appearance, flavor, and energy content to the active food, with electrolyte minerals replaced by carbohydrates) along with regular water intake at scheduled intervals during an exercise protocol under heat stress.
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
| 22 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy adult males aged 18 years or older who have sufficient physical fitness and exercise experience to safely complete the specified exercise protocol in the heat, and who have provided voluntary informed consent after fully understanding the study protocol.
Key exclusion criteria
Individuals with a history of cardiovascular, renal, or gastrointestinal diseases; a history of severe heat-related illness; known allergies to the test food ingredients; or those regularly taking medications that may affect metabolism, thermoregulation, or hydration status.
Target sample size
24
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 Science
Zip code
3550154
Address
111-1 Minami-Yoshimi, Yoshimi-machi, Hiki-gun, Saitama, Japan
TEL
4935515101
info@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
3550154
Address
111-1 Minamiyoshimi, Yoshimi, Saitama, Japan
TEL
4935515101
Homepage URL
nagashima-y@musashigaoka.ac.jp
Sponsor or person
Institute
Musashigaoka Junior College
Institute
Department
Personal name
Funding Source
Organization
Musashigaoka Junior College
Organization
Division
Category of Funding Organization
Other
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, Saitama, Japan
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 | 08 | Month | 26 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 03 | Month | 12 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 19 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 27 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 30 | 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 | 08 | Month | 26 | Day |
Last modified on
| 2026 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071777
