Healthy older adults
Conditions
Interventions
Test food intake with Karate exercises
Test food intake without Karate exercises
Control food intake with Karate exercises
Control food intake without Karate exercises
Sponsors
feileB Co., Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male and female individuals aged 65 to 79 years. 2) Healthy individuals capable of maintaining a one-legged stance with eyes open for 10 seconds or longer. 3) Individuals with a Body Mass Index (BMI) of 18.5 to less than 30.0 kg/m2. 4) Individuals who have received a full explanation of the study's purpose and procedures and have provided written informed consent prior to participation.
Exclusion criteria
Exclusion criteria: 1) Individuals meeting the diagnostic criteria for sarcopenia (handgrip strength less than 26 kg for male or less than 18 kg for female, and a gait speed less than 0.8 m/sec) 2) Individuals with knee osteoarthritis or rheumatoid arthritis. 3) Individuals with a regular exercise habit of twice or more per week. 4) Individuals who have practiced Karate within the past 3 months. 5) Individuals who have received medical treatment for joint pain (such as in the knees or lower back) within 3 months prior to the start of the study. 6) Individuals who have sustained severe musculoskeletal injuries (e.g., fractures, tendon ruptures, or muscle strains) within the past year, or who find it difficult to perform physical exercise due to musculoskeletal pain or discomfort. 7) Individuals with a history of gastrointestinal surgery (excluding appendectomy). 8) Individuals with a current or past medical history of serious diseases (e.g., malignant tumors, cardiac disease, or neurological disorders). 9) Individuals who routinely consume health foods (e.g., Food for Specified Health Uses [FOSHU], dietary supplements, Foods with Function Claims) or calcium/vitamin D supplements that may affect the study parameters. 10) Individuals who are unable to discontinue the consumption of health foods (e.g., FOSHU, dietary supplements) from the time of informed consent until the completion of the study. 11) Heavy drinkers with an average pure alcohol intake of 60g per day or more 12) Individuals with extremely irregular dietary habits. 13) Shift workers or night-shift workers. 14) Individuals with a history of anaphylactic shock. 15) Individuals with an allergy to Japanese yam (Yamaimo). 16) Individuals who have participated in other clinical trials within 3 months prior to the date of informed consent, or who plan to participate in other clinical trials during the study period. 17) Individuals judged to be inappropriate for participation by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gait function(gait speed, cadence, stride length, gait speed during cognitive tasks, and gait variability) | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual Analog Scale (VAS) for pain during walking, lower limb muscle strength (Stand-up Test), handgrip strength, bone metabolism markers (TRACP-5b, BAP, P1NP), DHEAs, estrogen, bone mineral density, skeletal muscle mass, balance tests: postural control (static balance) and postural stability during visual occlusion, and serum Rubicon protein levels (autophagy inhibitor), Safety assessment (blood tests, body weight, BMI, blood pressure, and adverse events). | — |
Countries
Japan
Contacts
Public ContactYoshihiro Otake
feileB Co., Ltd Clinical Research Support dev.
Outcome results
None listed