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

N/ANot Yet RecruitingNCT07729657

Bloomage Biotechnology Corp., Ltd.90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Healthy Japanese Individuals

Interventions

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Knee pain intensity evaluated by Visual Analogue Scale (VAS)

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.

Time frame: Baseline and Week 12

Secondary Outcomes

Total score based on the JKOM

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.

Time frame: Baseline, Week 1, and Week 12

Knee pain and stiffness subscale score based on the JKOM

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.

Time frame: Baseline, Week 1, and Week 12

Condition of daily life subscale score based on the JKOM

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.

Time frame: Baseline, Week 1, and Week 12

General activity subscale score based on the JKOM

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.

Time frame: Baseline, Week 1, and Week 12

Health conditions subscale score based on the JKOM

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.

Time frame: Baseline, Week 1, and Week 12

Number of participants showing an improvement of >= 1 grade in the JKOM questionnaire items

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.

Time frame: Week 1 and Week 12

Serum interleukin-6 (IL-6) level

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.

Time frame: Baseline and Week 12

Walking parameters evaluated by 10 m walk test

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).

Time frame: Baseline and Week 12

Lower limb muscle strength parameters evaluated by LocomoScan G

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.

Time frame: Baseline and Week 12

Number of stand-ups in the 30-second sit-to-stand test

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

Time frame: Baseline and Week 12

Body composition parameters

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.

Time frame: Baseline and Week 12

Body composition parameters (body height)

Body height is measured using a height rod

Time frame: Baseline

Body composition parameters (body mass index (BMI))

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

Time frame: Baseline and Week 12

Changes from baseline in body composition parameters

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).

Time frame: Baseline and Week 12

Percentage changes from baseline in body composition parameters

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%.

Time frame: Baseline and Week 12

Individuals who experienced adverse events

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.

Time frame: Intervention period

Individuals whose values of urinalysis and peripheral blood test are outside the reference range after intervention despite within the reference range at baseline

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.

Time frame: Baseline and Week 12

Systolic and diastolic blood pressure

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

Time frame: Baseline and Week 12

Parameters evaluated by urinalysis

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.

Time frame: Baseline and Week 12

Parameters evaluated by peripheral blood tests

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).

Time frame: Baseline and Week 12

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

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts