Healthy Japanese Individuals
Conditions
Keywords
Knee discomfort, Physical function, Muscle mass
Brief summary
The goal of this clinical trial is to test the effects of the test products on the locomotor system in healthy Japanese adults with low muscle mass and knee joint discomfort. The main question it aims to answer is: • Does the daily consumption of the test product improve subjective knee symptoms, quality of life (QOL), and physical function? Participants will be asked to: * Take 3 capsules of the test product daily for 12 weeks. * Complete questionnaires regarding subjective knee symptoms and QOL. * Undergo bilateral X-ray imaging. * Undergo assessment of lower limb extension strength. * Perform the stand-up test to evaluate lower limb muscle endurance. * Perform the 10-meter walk test to evaluate walking ability. * Undergo anthropometric and physical measurements. Researchers will compare Test Product 1, Test Product 2, and Test Product 3, against a placebo group to see if consumption of the study products improves knee symptoms, QOL, and physical function.
Interventions
DIETARY_SUPPLEMENTFood containing NAG and HA
Take 3 capsules with water daily for 12 weeks.
DIETARY_SUPPLEMENTFood containing NAG
Take 3 capsules with water daily for 12 weeks.
DIETARY_SUPPLEMENTPlacebo
Take 3 capsules with water daily for 12 weeks.
Sponsors
Bloomage Biotechnology Corp., Ltd.
Orthomedico Inc.
WORSO.Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Japanese 2. Men or women 3. Adults 4. Healthy individuals 5. Individuals whose body mass index is ≥18.5 and \<30 kg/m2 6. Individuals who have low whole-body muscle mass 7. Individuals with KL grades of 0 or I on radiographic examination 8. Individuals with high knee pain intensity using the JKOM, as measured by VAS
Exclusion criteria
1. Individuals receiving treatment for or have a history of malignant tumors, heart failure, or myocardial infarction 2. Individuals with an implanted pacemaker or implantable cardioverter-defibrillator 3. Individuals 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 consuming Foods for Specified Health Uses (FOSHU) or FFC 5. Individuals taking or using medications (including herbal medicines) or supplements 6. Individuals who are allergic to medications or foods related to the test product 7. Individuals engaging at least 60 minutes per week in physical activity that induces heavy breathing and sweating 8. Individuals engaging in strength training (including bodyweight exercises such as push-ups), running, walking, cycling, or swimming at least twice a week 9. Individuals who are pregnant, lactating, or planning to become pregnant during the study period 10. Individuals usually taking FOSHU or FFC, e.g., NAG, proteoglycan from salmon nasal cartilage (SNC), undenatured type II collagen from SNC, glucosamine hydrochloride, curcumin, elastin peptide from skipjack, or collagen peptide 11. Individuals engaging in intense knee joint-loading exercise (e.g., ball sports, such as soccer, baseball, and basketball, jogging, running, skiing, or snowboarding) 12. Individuals who use a cane or joint support, or may use them during this study 13. Individuals deemed unsuitable to participate in this study by the principal investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee pain intensity evaluated by Visual Analogue Scale (VAS) | Baseline and Week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total score based on the JKOM | Baseline, Week 1, and Week 12 | 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. |
| Knee pain and stiffness subscale score based on the JKOM | Baseline, Week 1, 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. |
| Condition of daily life subscale score based on the JKOM | Baseline, Week 1, and Week 12 | 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 activity subscale score based on the JKOM | Baseline, Week 1, and Week 12 | 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. |
| Health conditions subscale score based on the JKOM | Baseline, Week 1, 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. |
| Number of participants showing an improvement of >= 1 grade in the JKOM questionnaire items | Week 1 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. |
| Serum interleukin-6 (IL-6) level | Baseline and Week 12 | 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 parameters evaluated by 10 m walk test | Baseline and Week 12 | 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 parameters evaluated by LocomoScan G | Baseline and Week 12 | 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. |
| Number of stand-ups in the 30-second sit-to-stand test | Baseline and Week 12 | Lower-body muscle endurance will be assessed using a sit-to-stand test. |
| Body composition parameters | Baseline and Week 12 | 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 composition parameters (body height) | Baseline | Body height is measured using a height rod |
| Body composition parameters (body mass index (BMI)) | Baseline and Week 12 | BMI (kg/m\^2) is calculated as body weight (kg) divided by the square of body height (m). |
| Changes from baseline in body composition parameters | Baseline and Week 12 | 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). |
| Percentage changes from baseline in body composition parameters | Baseline and Week 12 | 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%. |
| Individuals who experienced adverse events | Intervention period | 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. |
| Individuals whose values of urinalysis and peripheral blood test are outside the reference range after intervention despite within the reference range at baseline | Baseline and Week 12 | 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 pressure | Baseline and Week 12 | Systolic and diastolic blood pressures will be measured using a digital blood pressure monitor. |
| Parameters evaluated by urinalysis | Baseline and Week 12 | 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. |
| Parameters evaluated by peripheral blood tests | Baseline and Week 12 | 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). |
Countries
Japan
Contacts
CONTACTNaoko Suzuki
CONTACTAsami Baba, PhD
STUDY_CHAIRTsuyoshi Takara, MD
Medical Corporation Seishinkai, Takara Clinic
Outcome results
None listed