Male/female adults
Conditions
Interventions
Oral consumption of the test food (1 capsule, once daily) for 8 weeks
Oral consumption of the placebo food (1 capsule, once daily) for 8 weeks
Sponsors
CPCC Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females aged 55 years to less than 70 years at the time of informed consent acquisition. 2. Individuals who are able to give informed consent to participate in this study after receiving a detailed explanation of the protocol and understanding its contents.
Exclusion criteria
Exclusion criteria: 1. Individuals engaged in physically demanding occupations such as heavy lifting. 2. Individuals who have maintained a habitual exercise routine for more than 1 year, consisting of 30 minutes or over of exercise at least twice per week. (Light daily activities such as casual walking are not considered habitual exercise; however, resistance training, dance, ball sports, and similar structured exercise are included.) 3. Individuals with irregular lifestyle patterns, including rotating shift work. 4. Individuals who have sustained injuries affecting physical function (e.g., fractures, tendon ruptures) within the past year. 5. Individuals who regularly consume Foods for Specified Health Uses, Foods with Function Claims, or health foods (including supplements) with claims (e.g., products marketed for reducing fatigue) and are unable to discontinue their use after providing consent. 6. Individuals who have routinely taken supplements containing vitamin D, amino acids, or polyunsaturated fatty acids (DHA/EPA) within the past 3 months, and are unable to discontinue their use after providing consent. 7. Individuals who routinely take medications or quasi-drugs that may affect the study outcomes (e.g., nutritional tonics for physical fatigue, restorative tonics, antibiotics, DHA/EPA-containing products) and who are unable to discontinue their use after providing consent. 8. Individuals who have taken steroids or hormonal agents (e.g., androgen- or estrogen-containing compounds) that may affect muscle function within the past 3 months, and those who cannot discontinue such agents after providing consent. 9. Individuals with limitations in activities of daily living, including those who require the use of a cane. 10. Individuals with excessive alcohol intake. 11. Individuals who have previously been identified as having electrocardiographic abnormalities during health examinations.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VO2max Changes in heart rate during exercise Changes in Borg Scale ratings before and after exercise Skeletal muscle mass Handgrip strength Lower-limb muscle strength Timed Up and Go (TUG) test Natural killer (NK) cell activity Interleukin-6 (IL-6) Growth differentiation factor 15 (GDF15) Lipopolysaccharide (LPS) Cognitrax cognitive test scores Athens Insomnia Scale score | — |
Countries
Japan
Contacts
Public ContactMasanori Numa
CPCC Company Limited Clinical Planning Department
Outcome results
None listed