Verification Study of the Effects of Consumption of the Test Food on the Musculoskeletal System

Knee pain intensity will be assessed using the VAS component of the Japanese Knee Osteoarthritis Measure (JKOM). The VAS scores range from 0 mm (no pain) to 100 mm (worst possible pain), with higher scores indicating greater pain intensity.

Subjective knee symptoms and QOL will be evaluated using the JKOM and a modified questionnaire based on the JKOM. The total score ranges from 0 to 100, with lower scores indicating fewer symptoms and better health status. For the assessment at Week 1, the questionnaire is modified to ask about the participant's knee condition over the past 1 week, rather than the standard 1-month period used at Baseline and Week 12.

Symptoms regarding pain and stiffness will be evaluated using the subscale of the JKOM. The subscale score ranges from 0 to 32, with lower scores indicating milder symptoms. This domain standardly assesses the participant's knee function over the past few days at all evaluation timepoints.

The impact on daily living status will be evaluated using the subscale of the JKOM. The subscale score ranges from 0 to 40, with lower scores indicating better performance in daily life. This domain standardly assesses the participant's ability to perform daily routines over the past few days at all evaluation timepoints.

General activities will be evaluated using the subscale of the JKOM and a modified questionnaire based on the JKOM. The subscale score ranges from 0 to 20, with lower scores indicating higher frequency/ease of activities. For the assessment at Week 1, the questions are modified to ask about the participant's condition over the past 1 week, rather than the standard 1-month period used at Baseline and Week 12.

General health conditions will be evaluated using the subscale of the JKOM and a modified questionnaire based on the JKOM. The subscale score ranges from 0 to 8, with lower scores indicating better general health status. For the assessment at Week 1, the questions are modified to ask about the participant's condition over the past 1 week, rather than the standard 1-month period used at Baseline and Week 12.

The number of participants who show an improvement of >= 1 grade from baseline in each individual question item of the JKOM and the modified JKOM questionnaire will be analyzed.

Approximately 13 mL of venous blood will be collected from each study participant, and analysis will be outsourced to LSI Medience Co., Ltd. These parameters are assessed as baseline data and efficacy endpoints.

Walking ability will be assessed on a level 10 m walking course with approach lanes before and after the course to allow the participant to reach a steady walking speed. The evaluated parameters include walking time, walking speed, number of steps, stride length, and step rate (number of steps per unit of time).

Lower limb muscle strength will be measured using the LocomoScan G (ALCARE Co., Ltd., Tokyo, Japan). The evaluated parameters include maximum muscle strength, muscle-to-body-weight ratio, and lower-limb age for both the right and left legs.

Lower-body muscle endurance will be assessed using a sit-to-stand test.

Body weight, body fat percentage, lean body mass, and segmental fat/muscle mass (for the total body, right leg, left leg, right arm, left arm, and trunk) are measured using a body composition analyzer. These parameters are calculated by the body composition analyzer.

Body height is measured using a height rod

BMI (kg/m^2) is calculated as body weight (kg) divided by the square of body height (m).

The change from baseline (Week 12 value minus Baseline value) will be evaluated using a body composition analyzer. The evaluated parameters include body weight, BMI, body fat percentage, lean body mass, and segmental fat/muscle mass (for the total body, right leg, left leg, right arm, left arm, and trunk).

The percentage change from baseline will be evaluated using a body composition analyzer. The evaluated parameters include body weight, BMI, body fat percentage, lean body mass, and segmental fat/muscle mass (for the total body, right leg, left leg, right arm, left arm, and trunk). The percentage change is calculated as: (Week 12 value minus Baseline value) / Baseline value * 100%.

During the study period, if a participant exhibits any clinically significant "new manifestation of abnormality" or "aggravation" in his/her physical signs and symptoms, it is considered to be an adverse event.

The ratio of cases which had test items stated in urinalysis and peripheral blood examination within their respective standard ranges before intervention but exceeded the ranges after intervention are calculated, intergroup comparison at each time point is performed using tests for comparing proportions.

Systolic and diastolic blood pressures will be measured using a digital blood pressure monitor.

Approximately 10 mL of urine will be collected from each participant. The analysis of each parameter will be outsourced to LSI Medience Corporation (Tokyo, Japan) and measured according to standard methods. The evaluated parameters include qualitative urine protein, qualitative urine glucose, urine pH, and urine occult blood.

Approximately 13 mL of venous blood will be collected from each participant. The analysis of each parameter will be outsourced to LSI Medience Corporation and measured according to standard methods. The evaluated parameters include white blood cell count (WBC), red blood cell count (RBC), hemoglobin (Hb), hematocrit (Ht), and platelet count (PLT), AST (GOT), ALT (GPT), gamma-GT (gamma-GTP), total bilirubin (T-BIL), total protein (TP), blood urea nitrogen (UN), creatinine (CRE), uric acid (UA), sodium (Na), potassium (K), chloride (Cl), serum amylase, total cholesterol (T-Cho), HDL-cholesterol (HDL-Cho), LDL-cholesterol (LDL-Cho), triglycerides (TG), glucose (GLU), and hemoglobin A1c (HbA1c: NGSP).