None listed
Conditions
Interventions
Oral intake of the test food for 48 weeks with an exercise intervention
Oral intake of the placebo food for 48 weeks with an exercise intervention
Oral intake of the test food for 48 weeks without an
Sponsors
Morinaga & Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Males or females aged 50-79 years who had provided informed consent. 2) Ability to perform the physical activities required for the conduct of the study. 3) Ability to provide their own smartphone and email address, and to download and use the program/app necessary for the study on that smartphone. 4) Ability to understand the study purpose and procedures, and participate voluntarily.
Exclusion criteria
Exclusion criteria: 1)A total HDS-R score of 20 or less at screening. 2)Difficulty with color discrimination or other problems that interfere with cognitive testing. 3)Unable to complete web questionnaires. 4)Current, prior, or suspected dementia, psychiatric, neurological, or cerebrovascular disease. 5)Current menopausal disorder. 6)Taking medications that could affect the study results. 7)Have undergone cognitive testing within 3 months before screening, or plan non-study cognitive testing during the study. 8)Having a disorder affecting motor function and currently receiving pharmacological treatment. 9)Regularly engaging in activities that influence motor function. 10)Absolute contraindication to exercise therapy or exercise stress testing. 11)Unable to perform measurements or exercise due to injury or illness. 12)Engage regularly in moderate-to-vigorous exercise totaling 3 hours or more per week. 13)Planned unavoidable intense exercise during the study. 14)Have major surgery planned during the study or are awaiting major surgery. 15)Current or past serious illnesses (e.g., malignant neoplasm, diabetes, liver, kidney, or heart disease). 16)Are at risk of developing an allergy related to the study. 17)Regularly using dietary supplements or medications containing the study's active ingredient. 18)Regularly consuming supplements intended to affect cognition, motor, or immune function. 19)Will have multiple occurrences of irregular lifestyle during the study. 20)Plan to change lifestyle habits during the study unrelated to participation in this study. 21)Regular heavy alcohol consumption. 22)Smoke 21 or more cigarettes per day. 23)Participation in another clinical trial within 1 month before consent, or planned during the study. 24)Pregnant or breastfeeding, or plan pregnancy during the study. 25)Judged unsuitable as a study subject based on responses to questionnaire or screening. 26)Any other reason the principal investigator considers the candidate unsuitable for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-minute walk test | — |
Secondary
| Measure | Time frame |
|---|---|
| grip strength, measurement of blood markers, cognitive assessment score | — |
Countries
Japan
Contacts
Public ContactShinpei Kawakami
Morinaga & Co., Ltd. Health Science and Research Center, R&D institute
Outcome results
None listed