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

Verification Study of the Effects of Consumption of the Test Food on the Musculoskeletal System: a Randomized, Placebo-controlled, Double-blind, Parallel-group Comparison Study

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 Overview

• Status: Not yet recruiting
• Conditions: Healthy Japanese Individuals
• Intervention / Treatment: Dietary supplement: Food containing NAG, HA, and PQQ; Dietary supplement: Food containing NAG and HA; Dietary supplement: Food containing NAG; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Naoko Suzuki; Phone Number: +81-3-3818-0610; Email: group_gakujutsu@orthomedico.jp
• Study Contact Backup: Name: Asami Baba, PhD; Phone Number: +81-3-3818-0610; Email: asami-baba@orthomedico.jp

Study Locations

• Japan
  • Tokyo
    • Nerima-ku, Tokyo, Japan, 176-0002
      • Nerima Medical Association Minami-machi Clinic
      • Contact: Naoko Suzuki; Phone Number: +81-3-3818-0610; Email: group_gakujutsu@orthomedico.jp
      • Contact: Asami Baba, PhD; Phone Number: +81-3-3818-0610; Email: asami-baba@orthomedico.jp
      • Principal Investigator: Masafumi Nagata, MD
    • Shinagawa-ku, Tokyo, Japan, 141-0022
      • Medical Corporation Seishinkai, Takara Clinic
      • Contact: Naoko Suzuki; Phone Number: +81-3-3818-0610; Email: group_gakujutsu@orthomedico.jp
      • Contact: Asami Baba, PhD; Phone Number: +81-3-3818-0610; Email: asami-baba@orthomedico.jp
      • Principal Investigator: Tsuyoshi Takara, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: NAG + HA + PQQ group; Participants in this arm will consume the active study product containing N-acetylglucosamine (NAG), hyaluronic acid (HA), and pyrroloquinoline quinone (PQQ).	Dietary supplement: Food containing NAG, HA, and PQQ; Take 3 capsules with water daily for 12 weeks.
Active Comparator: NAG + HA group; Participants in this arm will consume the active study product containing NAG and HA.	Dietary supplement: Food containing NAG and HA; Take 3 capsules with water daily for 12 weeks.
Active Comparator: NAG group; Participants in this arm will consume the active study product containing NAG.	Dietary supplement: Food containing NAG; Take 3 capsules with water daily for 12 weeks.
Placebo Comparator: Placebo group; Participants in this arm will consume a placebo product visually and organoleptically identical to the active products but without the active ingredients.	Dietary supplement: Placebo; Take 3 capsules with water daily for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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).	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.	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.	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.	Baseline and Week 12
Body composition parameters (body height)	Body height is measured using a height rod	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).	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).	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%.	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.	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.	Baseline and Week 12
Systolic and diastolic blood pressure	Systolic and diastolic blood pressures will be measured using a digital blood pressure monitor.	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.	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).	Baseline and Week 12

Collaborators and Investigators

• Sponsor: Bloomage Biotechnology Corp., Ltd.
• Collaborators: Orthomedico Inc.; WORSO.Co.,Ltd
• Investigators: Study Chair: Tsuyoshi Takara, MD, Medical Corporation Seishinkai, Takara Clinic

Study record dates

Study Major Dates

• Study Start (Estimated): July 30, 2026
• Primary Completion (Estimated): December 14, 2026
• Study Completion (Estimated): December 14, 2026

Study Registration Dates

• First Submitted: July 13, 2026
• First Submitted That Met QC Criteria: July 23, 2026
• First Posted (Actual): July 27, 2026

Study Record Updates

• Last Update Posted (Actual): July 27, 2026
• Last Update Submitted That Met QC Criteria: July 23, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Physical function; Muscle mass; Knee discomfort
• Other Study ID Numbers: 11127-0045-34

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data sharing will be discussed among the research affiliates after the study is completed.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No