UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061820 |
|---|---|
| Receipt number | R000070738 |
| Scientific Title | Effects of carbohydrate beverages on hydration statusbody fluid retention in young and middle-aged and older adults: a pilot study |
| Date of disclosure of the study information | 2026/06/08 |
| Last modified on | 2026/06/06 21:07:47 |
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Basic information
Public title
Effects of carbohydrate beverages on body fluid retentionhydration status in young and middle-aged and older adults
Acronym
Hydration study of carbohydrate beverages
Scientific Title
Effects of carbohydrate beverages on hydration statusbody fluid retention in young and middle-aged and older adults: a pilot study
Scientific Title:Acronym
Pilot hydration study of carbohydrate beverages
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This pilot study aims to investigate the effects of different carbohydrate beverages on body fluid retention in healthy young and middle-aged and older adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Urine volume
Key secondary outcomes
Body fluid balance parameters (e.g., plasma volume), blood glucose metabolism parameters (e.g., blood glucose, insulin), and questionnaires on subjective sensations
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
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingestion of water
Interventions/Control_2
Ingestion of a beverage containing glucose and fructose
Interventions/Control_3
Ingestion of an isomaltulose beverage
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
- Healthy male and female adults
- Age between 18 and 30 years or 40 and 65 years old
Key exclusion criteria
- Smokers
- obese individuals
- Participants with medical or surgical diseases
- Participants deemed inappropriate for the study by the principal investigator
Target sample size
20
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 2, Nishi-ku, Niigata, Niigata
TEL
025-262-7161
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 2, Nishi-ku, Niigata, Niigata
TEL
025-262-7161
Homepage URL
amano@ed.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Funding Source
Organization
Mitsui DM Sugar Co., Ltd.
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
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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 08 | 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 | 01 | Month | 14 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 17 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2028 | 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 | 06 | Month | 06 | Day |
Last modified on
| 2026 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070738
