UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058665 |
|---|---|
| Receipt number | R000067068 |
| Scientific Title | Verification of the effect of improving parent-child relationships when Calpis joint production experiences are carried out multiple times - Continuous use test - |
| Date of disclosure of the study information | 2025/08/01 |
| Last modified on | 2025/08/01 15:08:21 |
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Basic information
Public title
Verification of the effect of improving parent-child relationships when Calpis joint production experiences are carried out multiple times - Continuous use test -
Acronym
Verification of the effect of improving parent-child relationships when Calpis joint production experiences are carried out multiple times - Continuous use test -
Scientific Title
Verification of the effect of improving parent-child relationships when Calpis joint production experiences are carried out multiple times - Continuous use test -
Scientific Title:Acronym
Verification of the effect of improving parent-child relationships when Calpis joint production experiences are carried out multiple times - Continuous use test -
Region
| Japan |
Condition
Condition
Healthy voluntee
Classification by specialty
| Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By repeatedly conducting an experience in which parents and children collaboratively create and taste "Calpis" beverages, and comprehensively analyzing psychological scale questionnaires administered before and after the experience and communication features obtained during the experience, the factors that contribute to a good parent-child relationship, the interrelationships between them, and the impact that the continuation of the experience has on the parent-child relationship will be clarified.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Psychological questionnaire assessing the quality of the parent-child relationship and communication features extracted from video of the collaborative "Calpis" beverage experience (facial expressions, gaze behavior, vocal signals, conversational metrics, etc.).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Parents and children make and drink "Calpis" beverages for 8 weeks
Interventions/Control_2
Live a normal life without drinking "Calpis" beverages
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
| 4 | years-old | <= |
Age-upper limit
| 9 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)The participants must be one child between the ages of 4 (preschool age) and 3rd grade of elementary school, of Japanese nationality, and live in the Tokyo metropolitan area, and one parent.
2)Those who do not drink Calpis on a daily basis
Key exclusion criteria
1)Families with children with developmental disabilities or mental illnesses (because the purpose of the study is to understand the general state of parent-child relationships)
2)People who cannot drink Calpis
3)Families with children who drink Calpis on a daily basis
4)People who are allergic to Calpis, dairy products, or soybeans
5)People who do not agree with the purpose or content of the study
6)People who have significant difficulty communicating in Japanese
7)People who have previously participated in a similar study and are deemed to have the potential to influence the results
8)People with significant facial trauma, inflammation, swelling, or dermatologic disease
9)People whose facial movements (e.g., smiling) are restricted due to an underlying medical condition
Target sample size
66
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 Soft Drinks Co. Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Oruche Human Tech Lab, Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional review board of Tsukiji Futaba Clinic
Address
1-9-9, Tsukiji, Chuou-ku, Tokyo, Japan
Tel
03-6226-5812
tohru@hikobae.net
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 | 08 | Month | 01 | 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 | 31 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | 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 | 08 | Month | 01 | Day |
Last modified on
| 2025 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067068
