UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058277 |
|---|---|
| Receipt number | R000066426 |
| Scientific Title | Preliminary study concerning the effects of consumption of strong carbonated water on improving eating behavior, fatigue symptom, sleep, body composition, and physical activity |
| Date of disclosure of the study information | 2025/07/07 |
| Last modified on | 2025/07/16 07:19:41 |
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Basic information
Public title
Preliminary study concerning the effects of consumption of strong carbonated water on improving eating behavior, fatigue symptom, sleep, body composition, and physical activity
Acronym
Strong carbonated water in Sado Island
Scientific Title
Preliminary study concerning the effects of consumption of strong carbonated water on improving eating behavior, fatigue symptom, sleep, body composition, and physical activity
Scientific Title:Acronym
Strong carbonated water in Sado Island
Region
| Japan |
Condition
Condition
Mild obesity
Classification by specialty
| Medicine in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate strong carbonated water, we will examine the effects on changes in eating behavior, fatigue, sleep, and physical activity levels.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Eating behavior questionnaire
Key secondary outcomes
fatigue, sleep quality, body composition, alcohol consumption
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Drink 500 mL of strong carbonated water
Interventions/Control_2
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
| 30 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) able to participate the regular measurement sessions
(2) 30 years of age or older, and under 75 years
(3) Body Mass Index (BMI) of 23 kg/m2 or more
(4) who have been fully informed of the purpose and content of this study, are able to consent, have a good understanding of the study, volunteer to participate, and can give written consent to participate in this study
Key exclusion criteria
(1) pregnant or breastfeeding
(2) participants in other clinical studies within 3 months of consent
(3) who regularly drink carbonated water
(4) otherwise deemed ineligible by the study director
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tetsu |
| Middle name | |
| Last name | Kinoshita |
Organization
Institute of Community Life Sciences Co., Ltd.
Division name
Institute of Social Epidemiology
Zip code
791-0243
Address
Hiraimachi 1383-2, Matsuyama, Ehime
TEL
089-904-7811
tetsu.prospective@gmail.com
Public contact
Name of contact person
| 1st name | Tetsu |
| Middle name | |
| Last name | Kinoshita |
Organization
Institute of Community Life Sciences Co., Ltd
Division name
Institute of Social Epidemiology
Zip code
791--0243
Address
Hiramimachi 1383-2, Matsuyama, Ehime
TEL
0899047811
Homepage URL
tetsu.prospective@gmail.com
Sponsor or person
Institute
Institute of Community Life Sciences 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
Institutional Review Board (IRB) of Sado General Hospital
Address
161 Chigusa, Sado, Niigata 952-1209, Japan
Tel
0259-63-3121
kenko@js2.so-net.ne.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
sgh20250521-0311
Org. issuing International ID_1
Institutional Review Board (IRB) of Sado General Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 07 | 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
| 2025 | Year | 05 | Month | 21 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 06 | Month | 25 | Day |
Last modified on
| 2025 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066426
