Healthy Japanese
Conditions
Interventions
Duration: 12 weeks Test product: Lactic acid bacteria-containing food Exercise intervention: Perform resistance squat exercises equivalent to approximately 3.5 METs, 4 to 5 times per week (3 sets of
Sponsors
OSAKA SODA CO., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Individuals aged 60 or more 4. Healthy individuals 5. Individuals who have little or no exercise habit (i.e., exercising >=2 times per week, for >= 30 minutes per session, and continuing for >= 1 year) 6. Individuals with a short walking distance in the 6-minute walk test
Exclusion criteria
Exclusion criteria: 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction 2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 5. Individuals who are taking or using medications (including herbal medicines) or supplements 6. Individuals who are allergic to medicines or foods related to the test product 7. Individuals who experience pain while walking 8. Individuals who are unable to perform squats 9. Individuals who are pregnant, lactating, or planning to become pregnant during this study 10. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study 11. Individuals who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured value of the 6-minute walk distance at 12 weeks after intervention (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The change and percentage change in 6-minute walk distance from screening at 12w 2. The measured values of stand-up count, workload, walking time, walking speed, step count, stride length, and cadence at 12w, and their changes and percentage changes from screening 3. The measured values of body weight, body mass index (BMI), body fat percentage, fat mass, lean mass, muscle mass (whole body, right leg, left leg, right arm, left arm, trunk), waist circumference, AST (GOT), ALT (GTP), gamma-GT (gamma-GTP), total cholesterol (T-Cho), HDL-cholesterol (HDL-Cho), LDL-cholesterol (LDL-Cho), triglycerides (TG), lactic acid, and pyruvic acid at 12w, and their changes and percentage changes from screening | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed