UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054493 |
|---|---|
| Receipt number | R000062243 |
| Scientific Title | Effects of rehydration with electrolyte-enriched carbonated water on fluid intake behavior and fluid balance after mild hypohydration: randomized cross-over study |
| Date of disclosure of the study information | 2024/06/01 |
| Last modified on | 2025/05/28 10:37:43 |
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Basic information
Public title
Effects of electrolyte-enriched carbonated water on recovery from mild hypohydration
Acronym
Rehydration effect of electrolyte-enriched carbonated water
Scientific Title
Effects of rehydration with electrolyte-enriched carbonated water on fluid intake behavior and fluid balance after mild hypohydration: randomized cross-over study
Scientific Title:Acronym
Effect of ingesting electrolyte concentration in carbonated water on recovery from mild dehydration
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In recent years, global warming has increased the incidence of heat stroke during the summer, making it a significant health concern. Since hypohydration elevates the risk of heat stroke, preventing hypohydration through adequate fluid intake is crucial. Although the consumption of carbonated water has risen in recent years, little research has been conducted on its effects on fluid balance after dehydration. Sodium ion intake is essential for fully restoring fluid volume during hypohydration.
This study aims to examine the effects of carbonated water with added minerals on fluid intake behavior (including the amount and pattern of intake) when subjects are allowed to drink freely after dehydration. Additionally, we will assess the impact of freely consuming mineralized carbonated water on fluid balance, physiological function, mood, and taste. This study is expected to provide fundamental data for establishing effective water intake methods to prevent dehydration.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Body fluid balance during the 2-hour dehydration period and the 2 and 3-hour rehydration period, calculated from changes in body weight measured with an electric balance.
2. Fluid retention ratio 2-3 hours after the onset of fluid ingestion, calculated from the ingested fluid weight and fluid balance.
3. Fluid intake, which is measured by weighing with an electric balance for 2-3 hours after the onset of fluid ingestion
4. Urinary flow rate is calculated from the weight of sampled urine, in which subjects were asked to empty the urinary bladder, and the time between sampling
5. Urinary excretion rate of osmotically active substances, sodium, potassium, and chloride, are calculated from the urine flow rate and urine osmolality (osmometer), sodium, potassium, and chloride (ion-selective electrodes)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Electrolyte-enriched carbonated water intake after mild dehydration
Interventions/Control_2
Electrolyte-enriched water intake after mild dehydration
Interventions/Control_3
Carbonated water intake after mild dehydration
Interventions/Control_4
Water intake after mild dehydration
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adult men and women.
Key exclusion criteria
Those with renal disease, cardiovascular disease, metabolic disease, or BMI <18.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takamata |
| Middle name | |
| Last name | Akira |
Organization
Nara Women's University
Division name
Faculty of Human Life and Environment
Zip code
6308506
Address
Kitauoya Nishimachi, Nara
TEL
0742203469
takamata@cc.nara-wu.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Takamata |
Organization
Nara Women's University
Division name
Faculty of Human Life and Environment
Zip code
6308506
Address
Kitauoya Nishimachi, Nara
TEL
0742203469
Homepage URL
takamata@cc.nara-wu.ac.jp
Sponsor or person
Institute
Nara Women's University
Institute
Department
Personal name
Funding Source
Organization
Nara Women's University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee on Research with Human Subjects, Nara Women's University
Address
Kitauoya Higashimachi, Nara-city, Nara
Tel
0742203762
kenkyou@cc.nara-wu.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
| 2024 | Year | 06 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 17 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 12 | 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
| 2024 | Year | 05 | Month | 27 | Day |
Last modified on
| 2025 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062243
