UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055148 |
|---|---|
| Receipt number | R000063006 |
| Scientific Title | Effects of a 12-week functional water intake on anti-fatigue and health benefits |
| Date of disclosure of the study information | 2024/08/05 |
| Last modified on | 2025/11/07 15:32:33 |
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Basic information
Public title
Effects of a 12-week functional water intake
Acronym
Effects of a 12-week functional water intake
Scientific Title
Effects of a 12-week functional water intake on anti-fatigue and health benefits
Scientific Title:Acronym
Effects of a 12-week functional water intake on anti-fatigue and health benefits
Region
| Japan |
Condition
Condition
Healthy person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effects of a 12-week functional water intake on anti-fatigue and health benefits.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison of psychological, physiological, and biochemical parameters before and after the intake of the functional water.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) 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
Intake of the test drink twice a day for 12 weeks
Interventions/Control_2
Intake of the placebo drink twice a day for 12 weeks
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 and Female
Key inclusion criteria
1. Individuals aged 20 to 65 years who do not meet the exclusion criteria.
2. Individuals who understand the contents of the informed consent explanation and can provide written consent voluntarily.
Key exclusion criteria
1. Individuals with a history of serious diseases related to the brain, nervous system, cardiovascular system, or other severe conditions, or those currently undergoing treatment, including those taking prescribed medication.
2. Individuals with a history of seizures (such as loss of consciousness, coma, convulsions, etc.).
3. Individuals currently suffering from peptic ulcers (such as gastric ulcers).
4. Individuals with hearing or vision impairments that make it difficult to complete the essential evaluation items of this study.
5. Individuals who are currently pregnant or breastfeeding.
6. Individuals who cannot consume sugar-free carbonated beverages and cold drinks.
7. Individuals who have experienced symptoms of a vasovagal response due to blood sampling in the past.
8. Individuals currently participating in another clinical trial or who have participated in another interventional clinical trial within one month prior to obtaining consent.
9. Individuals who cannot comply with operational instructions for the trial (e.g., wearing masks for infection prevention).
10. Individuals deemed unsuitable by the principal investigator.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Kei |
| Middle name | |
| Last name | Mizuno |
Organization
Osaka Metropolitan University
Division name
Center for Health Science Innovation
Zip code
5300011
Address
3-1 Ofuka-cho, Kita-ku, Osaka City, JAPAN
TEL
+81-6-6485-0288
kyosuke.watanabe@dragon.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Kyosuke |
| Middle name | |
| Last name | Watanabe |
Organization
Osaka Metropolitan University
Division name
Center for Health Science Innovation
Zip code
5300011
Address
3-1 Ofuka-cho, Kita-ku, Osaka City, JAPAN
TEL
+81-6-6485-0288
Homepage URL
kyosuke.watanabe@dragon.kobe-u.ac.jp
Sponsor or person
Institute
ASAHI SOFT DRINKS CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
ASAHI SOFT DRINKS 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
Ethics Committee of Precision Healthcare Research Organization
Address
1-8-30 Tenmabashi, Kita-ku, Osaka City
Tel
+81-6-4309-6075
info@j-phr.org
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 | 08 | Month | 05 | 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
| 2024 | Year | 06 | Month | 29 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 12 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 07 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 08 | 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 | 08 | Month | 02 | Day |
Last modified on
| 2025 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063006
