UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055119 |
|---|---|
| Receipt number | R000062963 |
| Scientific Title | Health guidance and carbonated water as workplace health measures Verification of the effects of continuous intake on eating habits and body weight |
| Date of disclosure of the study information | 2024/07/30 |
| Last modified on | 2025/06/10 19:58:23 |
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Basic information
Public title
Health guidance and carbonated water as workplace health measures
Verification of the effects of continuous intake on eating habits and body weight
Acronym
Health guidance and carbonated water as workplace health measures
Verification of the effects of continuous intake on eating habits and body weight
Scientific Title
Health guidance and carbonated water as workplace health measures
Verification of the effects of continuous intake on eating habits and body weight
Scientific Title:Acronym
Health guidance and carbonated water as workplace health measures
Verification of the effects of continuous intake on eating habits and body weight
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify whether incorporating carbonated water into daily life changes dietary behavior.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Life record analysis values (frequency and amount of snacks/night snacks)
Key secondary outcomes
Blood test values, physical measurements
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Consume 500ml/day of unsweetened carbonated water for 12 weeks
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Japanese men and women aged over 20 at the time of obtaining consent
2) Drinking less than 500ml of unsweetened carbonated water per week
3) Those who have a habit of consuming snacks, late-night snacks, and sugary drinks (at least twice a week)
4) Those who have a drinking habit (more than once a week)
5) Records that can be filled in.
6) Those who have received a sufficient explanation of the purpose and content of the research and have given their free will and written consent to participate.
Key exclusion criteria
1) Those who exhibit hypersensitivity to research foods
2) Those who are pregnant or breastfeeding
3) Those who cannot consume research foods as directed
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Hashimoto |
Organization
Asahi SoftDrink Sales Co., Ltd.
Division name
Research & Development Strategy Department
Zip code
302-0106
Address
1-1-21 Midori, Moriya, Ibaraki Japan
TEL
0297(46)1728
hideki.hashimoto@asahiinryo.co.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Hashimoto |
Organization
Asahi SoftDrink Sales Co., Ltd.
Division name
Research & Development Strategy Department
Zip code
302-0106
Address
1-1-21 Midori, Moriya, Ibaraki Japan
TEL
0297(46)1728
Homepage URL
hideki.hashimoto@asahiinryo.co.jp
Sponsor or person
Institute
Asahi SoftDrink Sales Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Asahi SoftDrink Sales 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
Mibyou Research Ethics Review Committee
Address
2-18-4 Kandamisakicho,Chiyoda-ku, Tokyo
Tel
03-6272-9163
renraku@npo-mibyou.com
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 | 07 | Month | 30 | 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
Completed
Date of protocol fixation
| 2024 | Year | 07 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 30 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 31 | 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 | 07 | Month | 30 | Day |
Last modified on
| 2025 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062963
