UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060344 |
|---|---|
| Receipt number | R000069033 |
| Scientific Title | Study on the effects of sports drink consumption on psychological and physiological data -Randomized double-blind placebo-controlled crossover trial- |
| Date of disclosure of the study information | 2026/01/14 |
| Last modified on | 2026/01/13 22:27:46 |
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Basic information
Public title
Study on the effects of sports drink consumption on psychological and physiological data
Acronym
Study on the effects of sports drink consumption on psychological and physiological data
Scientific Title
Study on the effects of sports drink consumption on psychological and physiological data
-Randomized double-blind placebo-controlled crossover trial-
Scientific Title:Acronym
Study on the effects of sports drink consumption on psychological and physiological data
-Randomized double-blind placebo-controlled crossover trial-
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze the effects of test food on psychological and physiological data
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Heart rate, Body surface temperature, Temperature and humidity inside clothing
Key secondary outcomes
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
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Single administration of test food1
Interventions/Control_2
Single administration of test food2.
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
| 30 | years-old | > |
Gender
Male
Key inclusion criteria
(1) Healthy males aged 18 years or older and under 30 years old at the time of obtaining consent.
(2) The ability to obtain consent.
(3) No health abnormalities at the time of obtaining consent.
Key exclusion criteria
(1)People deemed inappropriate for participation in this study by the principal investigator.
(2)People with irregular lifestyles, such as those working rotating night shifts.
(3)People who is sensitive to hot and humid environments or confined spaces.
(4)People weighing less than 50 kg.
(5)People with systolic blood pressure below 90 mmHg.
(6)People with allergies to the ingredients contained in the test food.
(7)People who have withdrawn their consent.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Kazunori |
| Middle name | |
| Last name | Kato |
Organization
Toyo University
Division name
Department of Nutrition Sciences, Faculty of Health and Sports Sciences
Zip code
115-8650
Address
1-7-11 Akabane-dai, Kita-ku, Tokyo
TEL
03-5924-2836
k-kato@toyo.jp
Public contact
Name of contact person
| 1st name | Kazunori |
| Middle name | |
| Last name | Kato |
Organization
Toyo University
Division name
Department of Nutrition Sciences, Faculty of Health and Sports Sciences
Zip code
115-8650
Address
1-7-11 Akabane-dai, Kita-ku, Tokyo
TEL
03-5924-2836
Homepage URL
k-kato@toyo.jp
Sponsor or person
Institute
Toyo University
Institute
Department
Personal name
Funding Source
Organization
Suntory beverage & Food limited.
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
CCES Corporation
Address
969-367 Mitsubori, Noda, Chiba 278-0011, Japan
Tel
080-9826-2501
atsushi.kudou@cces.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 | 01 | Month | 14 | 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 | 12 | Month | 16 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 15 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 14 | 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
| 2026 | Year | 01 | Month | 13 | Day |
Last modified on
| 2026 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069033
