UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053167 |
|---|---|
| Receipt number | R000060676 |
| Scientific Title | Verification of the effect of continuous intake of carbonated water on eating and drinking habits |
| Date of disclosure of the study information | 2023/12/19 |
| Last modified on | 2024/06/11 12:05:40 |
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Basic information
Public title
Verification of the effect of continuous intake of carbonated water on eating and drinking habits
Acronym
Verification of the effect of continuous intake of carbonated water on eating and drinking habits
Scientific Title
Verification of the effect of continuous intake of carbonated water on eating and drinking habits
Scientific Title:Acronym
Verification of the effect of continuous intake of carbonated water on eating and drinking habits
Region
| Japan |
Condition
Condition
Healthy adult
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
Meal record analysis values (calories, three major nutrients)
Key secondary outcomes
Blood test values, physical measurements, life diary (Number of snacks, Alcohol consumption)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Consume 500ml/day of unsweetened carbonated water for 12 weeks
Interventions/Control_2
Drink 500ml/day of water 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) Japanese men and women aged 20 to 65 at the time of obtaining consent
2) Healthy individuals who have not received any treatment
3) Those with a BMI of 23.0 kg/m2 or more and less than 30.0 kg/m2
4) Drinking less than 500ml of unsweetened carbonated water per week
5) Those who have a habit of consuming snacks, late-night snacks, and sugary drinks (at least twice a week)
6) Those who have a drinking habit (more than once a week)
7) Must be able to visit the designated testing facility and fill out records.
8) 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 suffering from a disease
2) Those with drug and food allergies
3) Those who exhibit hypersensitivity to research foods
4) Those who are pregnant or breastfeeding
5) Those who have collected more than 200ml of blood within one month or more than 400ml within three months before consent was obtained.
6) Drinking more than 60g of alcohol per day
7) Those who smoke more than 20 cigarettes per day
8) Those who have a habit of strength training (at least 5 times a week)
9) Those who cannot refrain from ingesting foods for specified health uses, foods with functional claims, and other so-called health foods during the research period.
10) Those who cannot consume research foods as directed
11) Those participating in other clinical trials, clinical research, or clinical trials
12) Those who cannot follow the doctor's instructions, or those who are judged to be inappropriate by the doctor.
Target sample size
46
Research contact person
Name of lead principal investigator
| 1st name | Soma |
| Middle name | |
| Last name | Ode |
Organization
Macromill, Inc.
Division name
Life Science Division
Zip code
1080075
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 | Soma |
| Middle name | |
| Last name | Ode |
Organization
Macromill, Inc.
Division name
Life Science Division
Zip code
1080075
Address
Shinagawa East One Tower. 11F, 2-16-1 Konan, Minato-ku, Tokyo, JAPAN
TEL
03-6716-0700
Homepage URL
ohde@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 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
医療法人社団菱秀会 金内メディカルクリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 19 | 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
46
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
| 2023 | Year | 11 | Month | 27 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 06 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 19 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 19 | Day |
Last modified on
| 2024 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060676
