Healthy adults
Conditions
Interventions
Participants will intake 1 g of powdered test food, 1 sachet, 1.0 g, with water once daily at any time for 24 weeks.
Participants will intake 1 g of powdered placebo food, 1 sachet, 1.0 g, with water
Sponsors
IMEQRD Co. Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 60 or older but less than 75 years. 2. Japanese male and female. 3. Aware of declines in muscle strength or muscle mass. 4. BMI of 18.5 kg/m^2 or greater but less than 25.0 kg/m^2. 5. Capable of entering data into an electronic diary using a smartphone or PC. 6. Provided written informed consent after receiving sufficient explanation regarding the study's purpose and content and voluntarily agreed to participate.
Exclusion criteria
Exclusion criteria: 1. Current or past history of severe diseases. 2. Individuals under physician-supervised dietary or exercise therapy. 3. Have a musculoskeletal disorder affecting mobility including sarcopenia. Sarcopenia is defined as meeting both of the following criteria: -SMI < 7.0 kg/m^2 for men or < 5.7 kg/m^2 for women -Handgrip strength < 28 kg for men, < 18 kg for women, or normal walking speed < 1 m/sec. 4. Regular use of medications or quasi-drugs (e.g., anti-diabetic drugs, laxatives, NSAIDs, steroids, or topical agents with anti-inflammatory effects) that may influence the study and inability to refrain from such use during the study except occasional use. 5. Habitual use of functional foods, health supplements, or dietary supplements targeting muscle strength or mass maintenance at least three times weekly. Habitual consumption of food products containing active study ingredients is also excluded unless discontinued from the time of consent through the study period. 6. History or current presence of drug or food allergies. 7. Excessive alcohol intake. 8. Excessive smoking habits. 9. Habitual engagement in strength training. 10. Shift workers with night shifts. 11. Anticipated significant changes in lifestyle including diet, sleep, or exercise during the study period. 12. Planned overseas travel during the study period. 13. Presence of implanted orthopedic metal devices. 14. Enrollment in another clinical trial within one month prior to obtaining consent, ongoing participation, or plans to participate in another trial during the study period. 15. Considered unsuitable for study participation by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Muscle mass | — |
Secondary
| Measure | Time frame |
|---|---|
| -Body composition (body weight, BMI, fat mass) -Bone mineral density -Physical performance (normal walking speed, Timed Up and Go [TUG] test, chair stand test, knee extension strength, handgrip strength) -Inflammatory markers (IL-6, high-sensitivity CRP) -Frailty criteria (based on the J-CHS criteria) - Profile of Mood States (POMS2) - MOS 36-Item Short-Form Health Survey (SF-36) -Blood tests (hematology and biochemical tests) -Physiological examinations (blood pressure, pulse rate) -Incidence of adverse events and side effects | — |
Countries
Japan
Contacts
Public ContactHirokuni Kayama
IMEQRD Co., Ltd Planning and Sales Department
Outcome results
None listed