UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057731 |
|---|---|
| Receipt number | R000065971 |
| Scientific Title | Study on the confirmation of hearing effects from test food intake |
| Date of disclosure of the study information | 2025/04/28 |
| Last modified on | 2025/07/23 13:01:26 |
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Basic information
Public title
Study on the confirmation of hearing effects from test food intake
Acronym
Study on the confirmation of hearing effects from test food intake
Scientific Title
Study on the confirmation of hearing effects from test food intake
Scientific Title:Acronym
Study on the confirmation of hearing effects from test food intake
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the efficacy on hearing of intake of test food for 24 consecutive weeks, using placebo as a control.
To assess relationship between food habit and hearing at the time of screening.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
the questionnaire on hearing 2002
Key secondary outcomes
J-Matrix Test, HHIE
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of test food for 24 consecutive weeks
Interventions/Control_2
Intake of placebo for 24 consecutive 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
| 60 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Healthy males and females from 60 to 79 years of age
(2) Subjects who recognize not hearing clearly in daily life due to aging
(3) Subjects who fully understand the purpose and content of the study and voluntarily agree to participate in the study
Key exclusion criteria
(1) Subjects who have been diagnosed as hearing loss or hearing impairment in the past
(2) Subjects who are diagnosed with dementia or have been diagnosed with it in the past
(3) Subjects who are under treatment serious diseases (e.g., liver disease, kidney disease, heart disease, lung disease, respiratory disease, endocrine disease or metabolic disorders)
(4) Subjects who are diagnosed as mental disorder or depressive illness or have those tendencies
(5) Subjects who are taking medication that affect the central nervous system (e.g., antipsychotic medication, antiparkinsonian drug, antimaniac drug, antiepileptic drugs, anticoagulants) or hypnotic or antianxiety agent, or subjects who have plans to change dosage of medication for sleep (hypnotic or antianxiety agent) during the study period
(6) Subjects who are taking healthy foods or Chinese herbal medicine related cognitive function or hearing
(7) Subjects who are smoking a lot or in the habit of consuming alcohol on a daily basis or with an extremely irregular food habit
(8) Subjects who have irregular lifestyle, or mainly active at midnight, or have experience working under constant noise
(9) Subjects who have experience working under constant noise
I have allergies to gelatin and eggs
(10) Subjects who are judged to be inappropriate as study subjects based on their answers to the lifestyle questionnaire
(11) Subjects who participate in other human clinical trials, or subjects who are participating in other clinical trials currently
(12) Subjects who plan to travel abroad during the study period
(13) Subjects who are judged to be inappropriate as study subjects based on the results of the pre-test
(14) Subjects who are judged as unsuitable for the study by the investigator for other reason
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yumi |
| Middle name | |
| Last name | Takeda |
Organization
Kewpie Corporation
Division name
R&D Division
Zip code
182-0002
Address
2-5-7 Sengawacho, Chofu-shi, Tokyo
TEL
03-5384-7759
yumi_takeda@kewpie.co.jp
Public contact
Name of contact person
| 1st name | Kaori |
| Middle name | |
| Last name | Yoshimura |
Organization
EP Mediate Co., Ltd.
Division name
Development Department Trial Planning Section
Zip code
162-0814
Address
6-29 Shinogawamachi, Shinjuku-ku, Tokyo
TEL
080-1193-3234
Homepage URL
yoshimura.kaori265@eps.co.jp
Sponsor or person
Institute
EP Mediate Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Kewpie Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguro-ku, Tokyo
Tel
03-6452-2712
nakajima.megumi888@eps.co.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
社会福祉法人新栄会 滝野川病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 28 | 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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 04 | Month | 24 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 24 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 02 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 23 | 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 | 04 | Month | 28 | Day |
Last modified on
| 2025 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065971
