UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062894 |
|---|---|
| Receipt number | R000071977 |
| Scientific Title | Optimal Marketing Communication for Foods with Function Claims: A Survey of Purchase Intentions for Functional Wagashi Supporting Gut Health |
| Date of disclosure of the study information | 2026/10/01 |
| Last modified on | 2026/09/10 15:11:08 |
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Basic information
Public title
Optimal Marketing Communication for Foods with Function Claims: A Survey of Purchase Intentions for Functional Wagashi Supporting Gut Health
Acronym
A Study of How Information About Functional Wagashi Supporting Gut Health Affects Consumers Purchase Intentions
Scientific Title
Optimal Marketing Communication for Foods with Function Claims: A Survey of Purchase Intentions for Functional Wagashi Supporting Gut Health
Scientific Title:Acronym
A Study of How Information About Functional Wagashi Supporting Gut Health Affects Consumers Purchase Intentions
Region
| Japan |
Condition
Condition
Improvement of the Gastrointestinal Microbiome
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Chokatsu-an, a gut-health bean paste jointly developed by Hashimoto Food Industry Co., Ltd. and Fujita Health University, will be evaluated to investigate how functional foods influence consumers purchase intentions and to identify the most effective marketing communication strategies. Participants will undergo assessment of changes in their gut microbiota, taste the product, and complete a questionnaire regarding their purchase intentions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Effect of functional-information presentation on purchase intention for functional wagashi, assessed by questionnaire.
Key secondary outcomes
Evaluation of texture and taste of functional wagashi and changes in the gut environment (fecal gut microbiota) associated with consumption.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
functional wagashi
Interventions/Control_2
normal wagashi
Interventions/Control_3
none
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Individuals who receive written and oral explanations of the study, provide written informed consent, and voluntarily agree to participate in gut-health assessment, product tasting, and the questionnaire.
Key exclusion criteria
If a research participant requests withdrawal of consent or refuses further participation, their participation in the study will be discontinued at that time.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kazuko |
| Middle name | |
| Last name | Deno |
Organization
Osaka International University
Division name
Department of Business Administration
Zip code
570-8555
Address
6-21-57 Fujita-cho, Moriguchi-shi, Osaka
TEL
06-6902-0791
k-deno@oiu.jp
Public contact
Name of contact person
| 1st name | Kazuko |
| Middle name | |
| Last name | Deno |
Organization
Osaka International University
Division name
Department of Business Administration
Zip code
570-8555
Address
6-21-57 Fujita-cho, Moriguchi-shi, Osaka
TEL
06-6902-0791
Homepage URL
k-deno@oiu.jp
Sponsor or person
Institute
Osaka International University
Institute
Department
Personal name
Funding Source
Organization
Ibaraki city
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka International University
Address
6-21-57 Fujita-cho, Moriguchi, Osaka, Japan
Tel
06-6902-0791
k-deno@oiu.jp
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
| 2026 | Year | 10 | 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
60
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
| 2022 | Year | 10 | Month | 03 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 03 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 12 | Day |
Last follow-up date
| 2026 | 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
| 2026 | Year | 09 | Month | 12 | Day |
Last modified on
| 2026 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071977
