UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061490 |
|---|---|
| Receipt number | R000070359 |
| Scientific Title | Effects of AI-generated misinformation about the effectiveness of dietary supplements against diabetes on health beliefs and behavioral intentions among the Japanese general public: a randomized controlled trial |
| Date of disclosure of the study information | 2026/05/08 |
| Last modified on | 2026/05/08 14:53:44 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of AI-generated misinformation about the effectiveness of dietary supplements against diabetes on health beliefs and behavioral intentions
Acronym
AI Supplement Misinformation RCT (diabetes)
Scientific Title
Effects of AI-generated misinformation about the effectiveness of dietary supplements against diabetes on health beliefs and behavioral intentions among the Japanese general public: a randomized controlled trial
Scientific Title:Acronym
AI Supplement Misinformation RCT (diabetes)
Region
| Japan |
Condition
Condition
Exposure to dietary supplement misinformation related to diabetes
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine whether exposure to AI-generated misinformation about the anti-diabetes effectiveness of dietary supplements affects beliefs about the anti-diabetes effectiveness of dietary supplements, purchase or intake intentions, information-sharing intentions, and intentions to consult health professionals among the Japanese general public.
Basic objectives2
Others
Basic objectives -Others
To examine the effects of exposure to health misinformation on health beliefs and behavioral intentions
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Beliefs about the effectiveness of dietary supplements against diabetes. This outcome is assessed using 12 items covering four dietary supplements: royal jelly, DHA and EPA, soy isoflavones, and calcium. For each supplement, three items assess perceived effectiveness for regulating blood glucose levels, improving insulin function related to blood glucose regulation, and preventing diabetes. Each item is rated on a 6-point Likert scale ranging from 1 = strongly disagree to 6 = strongly agree. Outcomes are measured before and immediately after viewing the intervention or control message. The primary analysis uses the post-message score as the primary endpoint.
Key secondary outcomes
Secondary outcomes include: 1) general beliefs about the health-promoting, disease-preventive, and disease-treatment effects of dietary supplements; 2) intentions to purchase or use dietary supplements for regulating blood glucose levels, improving insulin function, or preventing diabetes; 3) intentions to share AI-generated information claiming that dietary supplements are effective against diabetes via social media or word of mouth; and 4) intentions to consult health professionals about dietary supplement use. Each item is rated on a 6-point Likert scale ranging from 1 = strongly disagree to 6 = strongly agree. Outcomes are measured before and immediately after viewing the intervention or control message.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
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
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants in the intervention group view AI generated misinformation claiming that one of four dietary supplements, royal jelly, DHA and EPA, soy isoflavones, and calcium is effective for regulating blood glucose levels, improving insulin function related to blood glucose regulation, and preventing diabetes. The message is viewed once during the web-based survey. After viewing the message, participants answer questions on health beliefs and behavioral intentions. At the end of the survey, accurate information and cautionary statements are provided to prevent misunderstanding.
Interventions/Control_2
Participants in the control group view AI generated accurate information stating that one of the same four dietary supplements,royal jelly, DHA and EPA, soy isoflavones, and calcium is not effective for regulating blood glucose levels, improving insulin function related to blood glucose regulation, and preventing diabetes. The message is viewed once during the web-based survey. After viewing the message, participants answer questions on health beliefs and behavioral intentions.
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Individuals aged 18 to 64 years
Registered panel members of a Japanese survey company who are able to complete an online survey
Individuals who have experience using generative AI
Individuals who provide informed consent online
Key exclusion criteria
Individuals who are not aware of dietary supplements
Individuals who have no experience using generative AI
Health care professionals, including physicians, nurses, pharmacists, registered dietitians, and dietitians
Individuals working in the AI field, including AI researchers or developers
Individuals with a personal or household history of cancer
Individuals currently receiving dietary therapy under the guidance of health professionals
Individuals who fail the attention-check question
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Okuhara |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Health Communication, School of Public Health
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
+81-3-5841-3304
okuhara-ctr@umin.ac.jp
Public contact
Name of contact person
| 1st name | Mingxin |
| Middle name | |
| Last name | Liu |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Health Communication
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
09062421998
Homepage URL
liumingxin98@g.ecc.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science KAKENHI
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Health Communication, School of Public Health, The University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel
03-5800-8781
okuhara.hc@gmail.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
| 2026 | Year | 05 | Month | 08 | 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
991
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
| 2026 | Year | 03 | Month | 04 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 03 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 20 | 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 | 05 | Month | 08 | Day |
Last modified on
| 2026 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070359
