Effects of continuous intake of study foods on auditory function- double-blind, placebo-controlled, parallel-group study.
- Conditions
- Healthy subjects
- Registration Number
- JPRN-UMIN000046947
- Lead Sponsor
- HUMA R&D CORP
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 100
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hearing in Noise Test-Japanese
- Secondary Outcome Measures
Name Time Method (Secondary outcomes) J-matrix test, temporal processing measurement, Visual Analog Scale (Safety evaluation) Vital signs, body measurements(weight,BMI), blood biochemistry, hematology, adverse events