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Study on the confirmation of hearing effects from test food intake

Study on the confirmation of hearing effects from test food intake - Study on the confirmation of hearing effects from test food intake

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000057731
Enrollment
100
Registered
2025-04-28
Start date
2025-05-02
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy adult

Interventions

Intake of test food for 24 consecutive weeks Intake of placebo for 24 consecutive weeks

Sponsors

EP Mediate Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
the questionnaire on hearing 2002

Secondary

MeasureTime frame
J-Matrix Test, HHIE

Countries

Japan

Contacts

Public ContactKaori Yoshimura

EP Mediate Co., Ltd. Development Department Trial Planning Section

yoshimura.kaori265@eps.co.jp080-1193-3234

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026