Healthy adults
Conditions
Interventions
Intake of test food for 16 weeks
Intake of placebo food for 16 weeks
Sponsors
Miura Clinic, Medical Corporation Kanonkai
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Japanese men and women aged between 40 and 69. (2) Subjects who feel a decline in cognitive function, motor function, or auditory function (falling under any of the categories below). 1. A total score of 7 or more on the SCD-Q (My-Cog) 2. A total score of 7 or more on the Locomo 25 3. A score of 18 or higher on the HHIA (3) Subjects who received sufficient explanation about the purpose and content of the test, had the ability to consent, voluntarily volunteered to participate after understanding it well, and agreed to participate in the test in writing.
Exclusion criteria
Exclusion criteria: (1) SUbjects with a history of mental illness, diabetes, liver diseases, renal disease, gastrointestinal disease, cardiac disease, respiratory disesase, peripheral vascular disease, or other serious disease (2) Subjects who have had surgery on the digestive tract (excluding appendectomy) (3) Subjects with a current medical condition or a history of a serious medical condition that required medical treatment (4) Subjects with autoimmune diseases (Graves' disease, rheumatoid arthritis, Hashimoto's thyroiditis, type 1 diabetes, systemic lupus erythematosus, polymyositis, Sjogren's syndrome, systemic sclerosis, etc.) or a history of such diseases (5) Subjects with mental illness (depression, etc.), chronic fatigue syndrome, or insomnia, or subjects with a history of such disorders (6) Subjects undergoing treatment (including counseling) for sleep, stress, or fatigue (7) Subjects who are unable to walk independently. (8) Subjects with anemia symptoms (9) Subjects who regularly use medicines, foods for specified health uses, health foods, etc. that may affect the study (10) Subjects who are at risk of developing allergies related to the study (11) Subjects who wish to become pregnant during the study period, pregnant women (including those who may be pregnant), or breastfeeding subjects (12) Subjects with a MMSE-J score of 23 or less in the screening test (13) Subjects who participate in strenuous sports and subjects who are trying to lose weight (14) Subjects who drink more than 40 g of average daily pure alcohol (15) Subjects who smoke an average of 21 or more cigarettes per day (16) to (18) are listed in the "Other related information" column
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subjective cognitive decline-questionnaire(My-Cog) 25-question geriatric locomotive function scale Hearing Handicap Inventory for Adults . | — |
Secondary
| Measure | Time frame |
|---|---|
| Subjective cognitive decline-questionnair(Their-Cog) Everyday memory checklist Mini-Mental State Examination - Japanese version Brain Health Check R Grip Strength Body composition(Muscle Mass, Appendicular Skeletal Muscle Index, Phase Angle) Hearing Disability and Handicap Scale Tinnitus Handicap Inventory Oral Fraily Index-8 Oral Health Impact Profile-49 National Eye Institute Visual Function Questionnaire-25 Center for Epidemiologic STudies Deoression Scale Skindex-29 | — |
Countries
Japan
Contacts
Public ContactMakoto Terashima
Oneness Support Co., Ltd. Clinical Trial Division
Outcome results
None listed