UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058368 |
|---|---|
| Receipt number | R000066713 |
| Scientific Title | Verification of the effect of continuous intake of carbonated water on smoking habits |
| Date of disclosure of the study information | 2025/07/04 |
| Last modified on | 2025/07/04 11:54:56 |
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Basic information
Public title
Verification of the effect of continuous intake of carbonated water on smoking habits
Acronym
Verification of the effect of continuous intake of carbonated water on smoking habits
Scientific Title
Verification of the effect of continuous intake of carbonated water on smoking habits
Scientific Title:Acronym
Verification of the effect of continuous intake of carbonated water on smoking habits
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify whether incorporating carbonated water into daily life contributes to reducing the number of cigarettes smoked by smokers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of cigarettes smoked
Key secondary outcomes
Psychological nicotine dependence, physical nicotine dependence, exhaled CO concentration/carboxyhemoglobin level
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is 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
Consume 500ml/day of unsweetened carbonated water for 8 weeks
Interventions/Control_2
Consume 500ml/day of placebo foods for 8 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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Japanese men and women aged 20 to 60 years old at the time of consent
2) Healthy individuals not undergoing any medical treatment or medication(Except when using medication as needed)
3) Drinking less than 500ml of unsweetened carbonated water per week
4) Those who are able to record the specified information
5) Those who have been fully informed of the purpose and content of the study and have given their voluntary consent
6) Those who use cigarettes or heated tobacco products
7) Those who smoke 10 or more cigarettes per day
8) Those who intend to quit smoking
9) Those whose daily smoking volume does not fluctuate much
Key exclusion criteria
1) Those with drug or food allergies
2) Those who dislike the study foods
3) Pregnant or breastfeeding people
4) Those who cannot refrain from taking foods for specified health uses, functional foods, or other so-called health foods during the study period
5) Those who cannot take the study foods as instructed
6) Those who participating in other clinical trials, research, or clinical studies
7) Those who the principal investigator deems inappropriate
8) Those using smoking cessation clinics/smoking cessation medications, etc.
9) Those whose number of cigarettes smoked has been restricted by a doctor, etc.
10) Those using things other than medicine (foods, drinks, supplements, etc.) to reduce the number of cigarettes smoked
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Soma |
| Middle name | |
| Last name | Ode |
Organization
Macromill, Inc.
Division name
Clinical Trial Unit, Life Science Division
Zip code
108-0075
Address
Shinagawa East One Tower 11F, 2-16-1 Konan, Minato-ku, Tokyo, Japan
TEL
03-6716-0700
ohde@macromill.com
Public contact
Name of contact person
| 1st name | Aya |
| Middle name | |
| Last name | Takahashi |
Organization
Macromill, Inc.
Division name
Clinical Trial Unit, Life Science Division
Zip code
108-0075
Address
Shinagawa East One Tower 11F, 2-16-1 Konan, Minato-ku, Tokyo, Japan
TEL
080-5076-8663
Homepage URL
ay_takahashi@macromill.com
Sponsor or person
Institute
Macromill, Inc.
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 kanda-misakicho chiyoda-ku, Tokyo, Japan
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
| 2025 | Year | 07 | Month | 04 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 07 | Month | 03 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 03 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 04 | Day |
Last follow-up date
| 2025 | 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
| 2025 | Year | 07 | Month | 04 | Day |
Last modified on
| 2025 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066713
