Effects of continuous consumption of test foods on auditory function in subjects with perceived decline in hearing function -A single arm open-label study
- Conditions
- Healthy Adults
- Registration Number
- JPRN-UMIN000048951
- Lead Sponsor
- Macromill, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 100
Not provided
1. Persons who are diagnosed with hearing loss or abnormalities related to auditory function. 2. Persons who use hearing aids. 3. Persons who are diagnosed with dementia or have a tendency of dementia. 4. Persons who have mental disorder and have a history of taking medication or attending hospital, or currently attend hospital. 5. Persons who are on exercise or diet therapy under the supervision of a physician. 6. Persons who have current or history of drug or alcohol dependence. 7. Smokers or those who stopped smoking within the past 12 months. 8. Persons who have irregular lifestyle due to night work, shift work, etc. 9. Persons who have extremely irregular eating, sleeping, and other lifestyle habits. 10. Persons who have who have extremely unbalanced diet. 11. Persons who have any allergies to the ingredients used in the test food. 12. Persons who regularly take large amounts of the ingredients contained in test food. 13. Persons who have any chronic illnesses with medication and who have any serious disease histories. 14. Persons who are taking medicines regularly. 15. Persons who use medicines or foods with health claims, that may affect auditory function and those who are unable to stop taking them during the study period. 16. Persons who are breast-feeding, pregnant and planning or wishing to become pregnant during the study period. 17. Persons who have participated in other studies within the past three months before the start of current study, or those who intend to participate in other studies after consenting to the current study. 18. Persons who plan to travel abroad within one month prior to each examination. 19.Persons who are judged to be unsuitable as subjects based on the results of the pre-intervention test. 20.Persons who have donated more than 200 mL of blood within one month or 400 mL of blood within three months. 21.Persons who were judged as inappropriate for study participant by the principal investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Subjective effectiveness of auditory function (Hearing Questionnaire 2002) (Japanese version of the Hearing Disability and Handicap Scale) (Hearing Handicap Inventory for Adults or Hearing Handicap Inventory for the Elderly) (Visual analogue scale) Objective auditory function (Pure tone audiometry) (iCI-2004)
- Secondary Outcome Measures
Name Time Method