Healthy subjects
Conditions
Interventions
24-weeks intake of the test food
24-weeks intake of the placebo food
Sponsors
HUMA R&D CORP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Japanese men and women whose age at the time of obtaining written consent is a healthy person and a hearing person between the ages of 40 and 70. 2.Subject who feels that their auditory function is not as good as it used to be. 3.Subject with BMI>=18.5kg/m2 and <25kg/m2 (not applicable to obesity). 4.Subject who has received sufficient explanation of the purpose and content of this test, has the ability to consent, volunteered voluntarily after fully understanding, and agreed to participate in writing.
Exclusion criteria
Exclusion criteria: 1.Subject who has received a diagnosis (auditory processing disorder) related to deafness or abnormal hearing function by a doctor or a medical examination. 2.Subject who uses hearing aids. 3.Subject who has been or are prone to dementia in the past. 4.Subject who has been or are prone to depression in the past. 5.Subject who is attends the hospital due to mental or sleep disorders or have a history of mental illness in the past. 6.Subject who has or are prone to autism spectrum disorders, attention deficit hyperactivity disorder / attention deficit hyperactivity disorder in the past. 7.Subject who is currently undergoing medication or outpatient treatment due to some serious illness. 8.Subject who is currently exercising or dieting under the supervision of a doctor. 9.Subject with current or history of drug or alcohol dependence. 10.Subject who smokes or started smoking cessation within 12 months. 11.Subject with irregular life rhythms due to night shifts or shift work. 12.Subject who has extremely irregular eating or sleeping habits. 13.Subject who has an extremely unbalanced diet. 14.Subject who has serious diseases such as brain disease, malignant tumor, immune disease, diabetes, liver disease (hepatitis), renal disease, heart disease, thyroid disease, adrenal disease, and other serious current or past diseases such as metabolic disease. 15.Subject who uses or cannot refrains from using health foods, supplements, and medicines that affect hearing. 16.Subject who is extremely claustrophobic.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hearing in Noise Test-Japanese | — |
Secondary
| Measure | Time frame |
|---|---|
| (Secondary outcomes) J-matrix test, temporal processing measurement, Visual Analog Scale (Safety evaluation) Vital signs, body measurements(weight,BMI), blood biochemistry, hematology, adverse events | — |
Countries
Japan
Contacts
Public ContactHidemasa Toya
HUMA R&D CORP Clinical Development Department
Outcome results
None listed