The healthy older adults.
Conditions
Interventions
Beta-lactolin (Once a day for six weeks) &
cognitive training game (25 minutes daily for six weeks)
Placebo (Once a day for six weeks) &
cognitive training game (25 minutes daily for six weeks)
Beta-lactolin (Once a day for six weeks) &
active control game (25 minutes daily for six weeks)
Placebo (Once a day for six weeks) &
active control game (25 minutes daily for six weeks)
Sponsors
Institute of Development, Aging and Cancer, Tohoku University.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 120 healthy, right-handed, whose first language is Japanese, elderly men and women (age: 60 years and older, 75 years and younger). Those who do not regularly play games (less than 1 hour per week of games (including videos, computers, and smartphones) in the past 2 years). Those who are able to participate in a pre-test from 1 week before to the day before the intervention period, a 6-week intervention period, and a post-test from the day after the last day of the intervention to 1 week after.
Exclusion criteria
Exclusion criteria: 1. A person who continuously consumes whey enzyme-degraded enzyme-enriched foods, health foods, foods for specified health uses, foods with nutrient function, or functional foods at least once a week. 2. Taking protein-rich supplements (high-protein supplements) or foods (foods highlighted as "high-protein") for the purpose of increasing muscle strength at least once a week on a continuous basis. 3. Those who continuously consume medicines, health foods, food for specified health uses, food with nutrient function, or food with functional labeling for the purpose of improving cognitive function at least once a week. 4. Those with major life changes planned during the study period. 5. A person who constantly consumes more than the appropriate amount of alcohol (about 20 g of alcohol per day on a daily basis: about 1 medium bottle of beer, about 180 mL of wine, about 1 glass of sake, about 60 mL of whiskey double). 6. Those with a history of mental illness, diabetes, neurological disease, or heart disease (cardiac disease), or those with an MMSE score of 26 or less. 7. Smokers or those who have begun to quit smoking within 12 months prior to the pretest. 8. Currently participating in another study or participating in another clinical trial within the month prior to the pretest. 9. Taking medications that affect cognitive function (e.g., benzodiazepines, antidepressants, central nervous system drugs). 10. Those judged to be unsuitable as subjects based on their responses to the lifestyle questionnaire. 11. The presence of metal in the body 12. Claustrophobia. 13. People with extreme myopia 14. People with food allergies (especially those allergic to milk, eggs, wheat, buckwheat, peanuts, shrimp, and crab). 15. Those who are lactose intolerant. 16. Who are unable to perform either game interventions or complete a life intervention diary. Any other person who is deemed unsuitable as a subject by the physician-in-charge.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Brain MRI data | — |
Secondary
| Measure | Time frame |
|---|---|
| Cognitive function test scores: A Frontal assessment battery at bedside, Stroop test, Trail Making Test, Verbal fluency task, Mini-Mental State Examination, Raven's Progressive Matrices, Japanese Reading Ability Test, Logical Memory, Rivermead Behavioral Memory Test, visual paired-associates, Standard verbal paired-associate learning test, Digit Span Task, Memory Updating Task, Digital Cancellation Test, Digit Symbol-Coding, Symbol Search, Mental Rotation Task. Questionnaire test scores: State-Trait Anxiety Inventory, WHO-Five well-being index, General Health Questionnaire 12, Profile of Mood States, Center for epidemiologic studies depression scale, Geriatric Depression Scale, Subjective cognitive decline questionnaire, Two dimensional mood scale, and Apathy Scale, Pittsburgh Sleep Quality Index, Eating Habits, Ten Item Personality Inventory, Effortful Control Scale. | — |
Countries
Japan
Contacts
Public ContactYagi Ayano
Institute of Development, Aging and Cancer, Tohoku University. Department of Cognitive Health Science
Outcome results
None listed