UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061916 |
|---|---|
| Receipt number | R000070842 |
| Scientific Title | Fluid retention after ingestion of sucrose- and isomaltulose-containing beverages at low-to-moderate carbohydrate concentrations |
| Date of disclosure of the study information | 2026/06/15 |
| Last modified on | 2026/06/15 16:58:30 |
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Basic information
Public title
The Effects of Low-Carbohydrate Beverage Ingestion on Fluid Retention responses
Acronym
Low-Carbohydrate Beverage and Hydration Responses
Scientific Title
Fluid retention after ingestion of sucrose- and isomaltulose-containing beverages at low-to-moderate carbohydrate concentrations
Scientific Title:Acronym
Low-Carbohydrate Beverage and Hydration Responses
Region
| Japan |
Condition
Condition
NA
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The present study aimed to investigate the effects of sucrose- and isomaltulose-containing beverages at low-to-moderate carbohydrate concentrations (i.e., 1.5%, 4.0%, and 6.5%) on fluid-retention responses in healthy young adults at rest.
Basic objectives2
Others
Basic objectives -Others
NA
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total urine volume, beverage hydration index, and plasma volume
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
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Water : Participants consume 1 L of water over 30 min. After ingestion, participants rest in a seated or semi-recumbent position for 3 h. Each trial is separated by at least 7 days. Participants complete the water, sucrose, and isomaltulose trials in a randomized crossover order within each carbohydrate concentration condition; not all participants complete all three carbohydrate concentration conditions.
Interventions/Control_2
Sucrose-containing beverage: Participants consume 1 L of a sucrose-containing beverage over 30 min. The sucrose concentration is 1.5%, 4.0%, or 6.5%. After ingestion, participants rest in a seated or semi-recumbent position for 3 h. Each trial is separated by at least 7 days. Participants complete the water, sucrose, and isomaltulose trials in a randomized crossover order within each carbohydrate concentration condition; not all participants complete all three carbohydrate concentration conditions.
Interventions/Control_3
Isomaltulose-containing beverage: Participants consume 1 L of an isomaltulose-containing beverage over 30 min. The isomaltulose concentration is 1.5%, 4.0%, or 6.5%. After ingestion, participants rest in a seated or semi-recumbent position for 3 h. Each trial is separated by at least 7 days. Participants complete the water, sucrose, and isomaltulose trials in a randomized crossover order within each carbohydrate concentration condition; not all participants complete all three carbohydrate concentration conditions.
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
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Young healthy adults
Key exclusion criteria
1: Smokers and obese individuals
2: Individuals with a history of heart disease
3: Individuals with arrhythmia
4: Individuals with a history of bronchial asthma
5: Individuals with a history of gastrointestinal disorders
6: Individuals with epilepsy
7: Individuals taking medication for chronic conditions or other illnesses
8: Individuals who have previously experienced vagal nerve reflex associated with needle puncture
9: Individuals unable to draw their own blood
10: Individuals deemed ineligible by the principal investigator
Target sample size
36
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
Mitsui DM Sugar Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Human Ethics Committee of Niigata University
Address
8050 Igarashi-Ninocho, Nishiku, 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）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 15 | Day |
Related information
URL releasing protocol
NA
Publication of results
Unpublished
Result
URL related to results and publications
NA
Number of participants that the trial has enrolled
21
Results
Within each carbohydrate concentration condition (n = 12 each), participants consumed water, a sucrose-containing beverage, or an isomaltulose-containing beverage in a randomized crossover order. At a carbohydrate concentration of 6.5%, both sucrose- and isomaltulose-containing beverages reduced urine output and improved the beverage hydration index compared with water. In contrast, these fluid-retention effects were not observed at carbohydrate concentrations of 1.5% or 4.0%.
Results date posted
| 2026 | Year | 06 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
21 healthy young adults participated in this study. Twelve participants completed each carbohydrate concentration condition, and some participants took part in more than one carbohydrate concentration condition. Because this study used a crossover design, participants were not assigned to fixed parallel groups.
Participant flow
21 healthy young adults participated in this study. Twelve participants completed each carbohydrate concentration condition. Within each concentration condition, participants completed three trials in a randomized crossover order: water, sucrose-containing beverage, and isomaltulose-containing beverage. Some participants took part in more than one carbohydrate concentration condition. All participants completed their assigned trials and were included in the analyses of the primary outcomes, urine output and beverage hydration index.
Adverse events
No serious adverse events or other adverse events related to the study were observed.
Outcome measures
The primary outcome measures were cumulative urine output and beverage hydration index (BHI) after beverage ingestion. The secondary outcome measures were blood glucose concentration, plasma insulin concentration, plasma osmolality, percent change in plasma volume, thirst, stomach fullness, hunger, and beverage palatability.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 06 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 01 | 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 | 15 | Day |
Last modified on
| 2026 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070842
