N/A(healthy adults)
Conditions
Interventions
Ingestion of test food A for 16 weeks
Ingestion of test food B for 16 weeks
Ingestion of placebo for 16 weeks
Sponsors
Yamazaki Otolaryngology Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Japanese subjects aged 40-59 years. 2) Subjects who are healthy and Healthy persons who are not currently undergoing treatment for any serious illness. 3) Subjects who are concerned about their hearing. 4) Subjects with an average hearing level of less than 25 dB in a pure tone audiometry.
Exclusion criteria
Exclusion criteria: 1) Subjects who consume foods containing the same ingredients as the test foods on a daily basis. 2) Subjects who are not negative on the antigen test (simplified method) for the new coronavirus. 3)Subjects who have difficulty participating in the study due to liver disease, kidney disease, heart disease, respiratory disorder, endocrine disorder, metabolic disorder, neuropathy, consciousness disorder, diabetes (according to the standards set by the Japan Diabetes Society), and other diseases. 4)Subjects who go to the hospital or take medication for the treatment of lifestyle-related diseases such as hypertension, hyperglycemia, hyperuricemia, heart disease, and high cholesterol. 5) Subjects who are allergic to test foods. 6) Subjects who may change their lifestyle significantly during the test period. 7) Subjects who are pregnant, breastfeeding or planning to become pregnant during the test period. 8) Subjects with a history of major surgery in the gastrointestinal tract area, such as gastrectomy, gastrointestinal suture, or intestinal resection. 9) Subjects with a history of serious cardiovascular disease. 10)Subjects who regularly use medicines and health foods / supplements (including Food for Specified Health Uses, Foods with Functional Claims, and Food with Nutrient Function Claims) that may affect this study (however, those who can stop taking them when consent is obtained are not applicable) 11) Subjects who are participating in other clinical trials or within 4 weeks of completing the trial. 12) Heavy alcohol drinkers and excessive smokers 13)Subjects with extremely irregular eating habits 14)Late night and irregular shift workers 15) Subjects who do not agree with the purpose of the examination after receiving the explanation of the examination beforehand. 16) Any other subjects who are deemed by the investigator to be inappropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hearing test | — |
Countries
Japan
Contacts
Public Contactyoshimichi kozai
Kyowa Trial Co., Ltd. Clinical Trials Division
Outcome results
None listed