UMIN-CTR 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 | 2026/08/24 02:15:28 |
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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 for any of the following:
1. current smoking or BMI >=25 kg/m2;
2. history of cardiovascular disease, bronchial asthma, gastrointestinal disease, epilepsy, kidney disease, kidney stones, kidney dysfunction, electrolyte abnormalities, or endocrine disorders (e.g., diabetes), or presence of cardiac arrhythmia;
3. medication use for a chronic disease or other ongoing medical condition;
4. previous vasovagal reaction to needle puncture or blood sampling, or inability to undergo capillary blood sampling;
5. consumption >=3 times/week of foods for specified health uses, foods with functional claims, health foods, or supplements that may affect study outcomes (e.g., products containing capsaicin or spices or affecting blood flow, body temperature, or sweating);
6. alcohol intake >2 standard drinks/day or caffeine intake >400 mg/day;
7. relevant medication or food allergies;
8. current participation in a clinical study involving pharmaceuticals or health foods, completion of such a study within the previous 4 weeks, or planned participation in another clinical study after consent;
9. donation of blood components or 200 mL whole blood within 1 month, donation of 400 mL whole blood within 3 months, or total blood collection during the previous 12 months plus planned study collection >1200 mL;
10. pregnancy, lactation, or planned pregnancy during the study;
11. vomiting, diarrhea, or fever within 2 weeks before screening;
12. inability to comply with alcohol/caffeine washout requirements;
13. initiation or change of hormonal contraceptives within 3 months before screening; or
14. any other reason considered unsuitable by the principal investigator.
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
Open public recruiting
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 | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071415
