UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062398 |
|---|---|
| Receipt number | R000071415 |
| Scientific Title | Evaluation of Hydration-Related Physiological Responses Following Consumption of Functional Beverages |
| Date of disclosure of the study information | 2026/08/01 |
| Last modified on | 2026/07/30 10:10:23 |
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Basic information
Public title
Evaluation of Hydration-Related Physiological Responses Following Consumption of Functional Beverages
Acronym
Study of hydration beverage effects
Scientific Title
Evaluation of Hydration-Related Physiological Responses Following Consumption of Functional Beverages
Scientific Title:Acronym
Study of hydration beverage effects
Region
| Japan |
Condition
Condition
NA
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the effects of functional beverage consumption on body fluid balance.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Beverage hydration index
Key secondary outcomes
Cumulative urine output and net fluid balance
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
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Investigational hydration beverage A
Interventions/Control_2
Investigational hydration beverage B
Interventions/Control_3
Investigational hydration beverage C
Interventions/Control_4
Investigational hydration beverage D
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 and Female
Key inclusion criteria
Healthy young adult men and women, approximately 18-30 years of age, who are considered healthy based on self-report and do not have any diagnosed disease or symptoms requiring medical treatment, regular hospital visits, or medical follow-up.
Key exclusion criteria
Participants will be excluded if they:
1. are smokers or have obesity according to Japanese criteria (BMI >25);
2. have a history of cardiovascular disease;
3. have cardiac arrhythmia;
4. have a history of bronchial asthma;
5. have a history of gastrointestinal disease;
6. have epilepsy;
7. are taking medication for chronic disease or other ongoing medical conditions;
8. have previously experienced a vasovagal reaction associated with needle puncture or blood sampling;
9. are unable to undergo capillary blood sampling;
10. regularly consume foods for specified health uses, foods with functional claims, or health foods (including supplements) that may affect the study outcomes at least three times per week and are unable to discontinue them from the time of informed consent (e.g., products containing highly stimulating ingredients such as capsaicin or spices, or those affecting blood flow, body temperature, or sweating);
11. are heavy alcohol drinkers;
12. have allergies to medications or foods relevant to the study;
13. are currently participating in other clinical studies involving pharmaceuticals or health foods, are within 4 weeks of completing such studies, or plan to participate in another clinical study after providing consent for this study;
14. have donated blood components or 200 mL of whole blood within 1 month prior to the start of the study;
15. have donated 400 mL of whole blood within 3 months prior to the start of the study;
16. have a total blood collection volume within the 12 months prior to the study that, when combined with the planned blood collection volume for this study, exceeds 1200 mL; or
17. are considered unsuitable for participation by the principal investigator for any other reason.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Tatsuro |
| Middle name | |
| Last name | Amano |
Organization
Niigata University
Division name
Faculty of Education
Zip code
950-2181
Address
8050 Igarashi-Ninocho, Nishiku, Niigata
TEL
0252627161
amano@ed.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuro |
| Middle name | |
| Last name | Amano |
Organization
Niigata University
Division name
Faculty of Education
Zip code
950-2181
Address
8050 Igarashi-Ninocho, Nishiku, Niigata
TEL
0252627161
Homepage URL
amano@ed.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Tatsuro Amano
Funding Source
Organization
The Coca-Cola Company
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
The United States
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The human ethical committee of Niigata University
Address
8050, Igarashi 2, Nishi-ku, Niigata, Niigata
Tel
025-227-2625
ethics@adm.niigata-u.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
新潟大学教育学部（新潟県）/Faculty of Education, Niigata University, Niigata
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 01 | 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 | 07 | Month | 07 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 07 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 03 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 15 | 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 | 07 | Month | 30 | Day |
Last modified on
| 2026 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071415
