UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060377 |
|---|---|
| Receipt number | R000069067 |
| Scientific Title | Confirmation of the hydration effect of food intake on the body -A randomized, placebo controlled, double-blind, crossover trial- |
| Date of disclosure of the study information | 2026/01/16 |
| Last modified on | 2026/01/16 14:32:28 |
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Basic information
Public title
Confirmation of the hydration effect of food intake on the body
Acronym
Confirmation of the hydration effect of food intake on the body
Scientific Title
Confirmation of the hydration effect of food intake on the body
-A randomized, placebo controlled, double-blind, crossover trial-
Scientific Title:Acronym
Confirmation of the hydration effect of food intake on the body
-A randomized, placebo controlled, double-blind, crossover trial-
Region
| Japan |
Condition
Condition
Healthy male adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effect of a single intake of test foods on hydration of the body in males aged 20 to 65.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fluid balance
Key secondary outcomes
Water retention rate, urinary excretion, specific gravity, pH, hematocrit, blood viscosity, ALB, NA, K, UREA Nitrogen/Creatinine, Osmolarity, Plasma Volume, Body Weight
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
The test food is ingested once.
Interventions/Control_2
The control food is ingested once.
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male
Key inclusion criteria
(1) Men aged 20 years or older at the time of consent and under 65 years old at the end of the study
(2) Subjects who can be admitted to a designated facility on the scheduled date of visit
(3) Subjects who can enter data into an electronic diary using a PC, smartphone, etc.
(4) Those who have fully understood the purpose and content of this study and have obtained written consent.
Key exclusion criteria
1. Systolic blood pressure less than 90 mmHg.
2. Donated blood components or 200 mL or more whole blood within 4 weeks before study start.
3. Donated 400 mL or more whole blood within 12 weeks before study start.
4. Total blood drawn from the month before study start plus planned study draws exceeds 1200 mL.
5. Participating in other studies within 4 weeks after another study or planning other study participation during this study.
6. Any of the following
a. Heart liver gastrointestinal or kidney disease including complications
b. History of circulatory disease
c. Diabetes
d. Allergy to test or prescribed food
e. History of serious diseases such as cancer or tuberculosis
7. Undergoing medical treatment at screening SCR.
8. Regular use of drugs or quasi-drugs.
9. Smoking 11 cigarettes per day or more.
10. Average daily alcohol over 60 g or drinking more than 6 days per week.
11. Extremely irregular eating habits.
12. Shift or late-night worker.
13. Severe anemia.
14. History of poor mood or physical condition after blood sampling.
15. Difficulty with peripheral blood collection or major gastrointestinal surgery history such as gastrectomy gastrointestinal suturing or intestinal resection.
16. Deemed unsuitable by principal or sub-investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Maekawa |
| Middle name | |
| Last name | Toshihiro |
Organization
Suntory beverage & Food limited.
Division name
Development & Designed Department
Zip code
211-0067
Address
13-2 Imaikami-cho, Nakahara-ku, Kawasaki, Kanagawa, JAPAN
TEL
050-1804-0276
Toshihiro_Maekawa@suntory.co.jp
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Honjo |
Organization
Suntory beverage & Food limited.
Division name
Development & Designed Department
Zip code
211-0067
Address
13-2 Imaikami-cho, Nakahara-ku, Kawasaki, Kanagawa, JAPAN
TEL
050-1734-6882
Homepage URL
Takayuki_Honjo@suntory.co.jp
Sponsor or person
Institute
Transgenic Inc.
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
Iryouhoujinsyadan Shoureikan Shinsapporo Seiryou Hospital Ethics Review Board
Address
2-1-30,Atsubetsuhigashi 4-jo,Atsubetsu-ku,Sapporo city,Hokkaido
Tel
011-898-2151
chiken-be@hpgr.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
25324
Org. issuing International ID_1
Transgenic Inc.
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
医療法人社団翔嶺館 新札幌聖陵ホスピタル
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 16 | 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 | 18 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 19 | Day |
Last follow-up date
| 2026 | Year | 09 | 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 | 01 | Month | 16 | Day |
Last modified on
| 2026 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069067
