Healthy Japanese IndividualsNCT07729657
Verification Study of the Effects of Consumption of the Test Food on the Musculoskeletal System
A study testing Food containing NAG and HA and Food containing NAG in people with Healthy Japanese Individuals, run by Bloomage Biotechnology Corp., Ltd. at 2 sites in Japan.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Japanese Individuals
- What is being tested?
- Food containing NAG and HA and Food containing NAG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 2 sitesJapan
- Study dates
- 9 Sep 2026to 22 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Japanese
- Men or women
- Adults
- Healthy individuals
- Individuals whose body mass index is ≥18.5 and <30 kg/m2
- Individuals who have low whole-body muscle mass
- Individuals with KL grades of 0 or I on radiographic examination
- Individuals with high knee pain intensity using the JKOM, as measured by VAS
Who cannot join
- Individuals receiving treatment for or have a history of malignant tumors, heart failure, or myocardial infarction
- Individuals with an implanted pacemaker or implantable cardioverter-defibrillator
- 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
- Individuals consuming Foods for Specified Health Uses (FOSHU) or FFC
- Individuals taking or using medications (including herbal medicines) or supplements
- Individuals who are allergic to medications or foods related to the test product
Show all 13Show fewer
- Individuals engaging at least 60 minutes per week in physical activity that induces heavy breathing and sweating
- Individuals engaging in strength training (including bodyweight exercises such as push-ups), running, walking, cycling, or swimming at least twice a week
- Individuals who are pregnant, lactating, or planning to become pregnant during the study period
- 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
- Individuals engaging in intense knee joint-loading exercise (e.g., ball sports, such as soccer, baseball, and basketball, jogging, running, skiing, or snowboarding)
- Individuals who use a cane or joint support, or may use them during this study
- Individuals deemed unsuitable to participate in this study by the principal investigator
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Japan2 sites
Nerima Medical Association Minami-machi Clinic
Nerima-ku, Tokyo, 176-0002
Naoko Suzuki, +81-3-3818-0610, group_gakujutsu@orthomedico.jp
Asami Baba, PhD, +81-3-3818-0610, asami-baba@orthomedico.jp
Medical Corporation Seishinkai, Takara Clinic
Shinagawa-ku, Tokyo, 141-0022
Naoko Suzuki, +81-3-3818-0610, group_gakujutsu@orthomedico.jp
Asami Baba, PhD, +81-3-3818-0610, asami-baba@orthomedico.jp
About this study
Official title: 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?
Read more
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.
- Conditions
- Healthy Japanese Individuals
- Being tested
- Food containing NAG and HA, Food containing NAG, Placebo
- Keywords
- Knee discomfort, Physical function, Muscle mass
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food containing NAG and HADietary supplement
Take 3 capsules with water daily for 12 weeks.
Food containing NAGDietary supplement
Take 3 capsules with water daily for 12 weeks.
PlaceboDietary supplement
Take 3 capsules with water daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| NAG + HA group | Active comparator | Participants in this arm will consume the active study product containing NAG and HA. Receives: Dietary Supplement: Food containing NAG and HA |
| NAG group | Active comparator | Participants in this arm will consume the active study product containing NAG. Receives: Dietary Supplement: Food containing NAG |
| Placebo group | Placebo comparator | Participants in this arm will consume a placebo product visually and organoleptically identical to the active products but without the active ingredients. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Week 12
Secondary outcomes (20)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and Week 12
Body composition parameters (body height)
Body height is measured using a height rod
Measured: 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).
Measured: 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).
Measured: 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%.
Measured: 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.
Measured: 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.
Measured: Baseline and Week 12
Systolic and diastolic blood pressure
Systolic and diastolic blood pressures will be measured using a digital blood pressure monitor.
Measured: 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.
Measured: 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).
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start9 Sep 2026 (estimated)
- Primary completion22 Mar 2027 (estimated)
- Study completion22 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Japanese IndividualsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bloomage Biotechnology Corp., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Orthomedico Inc., WORSO.Co.,Ltd
- Responsible party
- Sponsor
- Investigators
- Tsuyoshi Takara, MD, Study chair, Medical Corporation Seishinkai, Takara Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07729657
- Sponsor's protocol ID
- 11127-0045-34
- Status last verified
- Sep 2026
- First submitted
- 13 Jul 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data sharing will be discussed among the research affiliates after the study is completed.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07729657
- Acronym / sponsor ID
- 11127-0045-34
- Conditions
- Healthy Japanese Individuals
- Keywords
- Knee discomfort, Physical function, Muscle mass
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Bloomage Biotechnology Corp., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Orthomedico Inc., WORSO.Co.,Ltd
- Study start
- 9 Sep 2026 (estimated)
- Primary completion
- 22 Mar 2027 (estimated)
- Study completion
- 22 Mar 2027 (estimated)
- First posted
- 27 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NAG + HA group | Active comparator | Dietary Supplement: Food containing NAG and HAParticipants in this arm will consume the active study product containing NAG and HA. |
| NAG group | Active comparator | Dietary Supplement: Food containing NAGParticipants in this arm will consume the active study product containing NAG. |
| Placebo group | Placebo comparator | Dietary Supplement: PlaceboParticipants in this arm will consume a placebo product visually and organoleptically identical to the active products but without the active ingredients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Japanese
- Men or women
- Adults
- Healthy individuals
- Individuals whose body mass index is ≥18.5 and <30 kg/m2
Key exclusion criteria (13 listed)
- Individuals receiving treatment for or have a history of malignant tumors, heart failure, or myocardial infarction
- Individuals with an implanted pacemaker or implantable cardioverter-defibrillator
- 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
- Individuals consuming Foods for Specified Health Uses (FOSHU) or FFC
- Individuals taking or using medications (including herbal medicines) or supplements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Food containing NAG and HATake 3 capsules with water daily for 12 weeks. | Dietary supplement | NAG + HA group |
| Food containing NAGTake 3 capsules with water daily for 12 weeks. | Dietary supplement | NAG group |
| PlaceboTake 3 capsules with water daily for 12 weeks. | Dietary supplement | Placebo group |
Primary outcome
Knee pain intensity evaluated by Visual Analogue Scale (VAS)
Time frame: 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.
20 secondary outcomes
Total score based on the JKOM
Time frame: Baseline, Week 1, and Week 12
Knee pain and stiffness subscale score based on the JKOM
Time frame: Baseline, Week 1, and Week 12
Condition of daily life subscale score based on the JKOM
Time frame: Baseline, Week 1, and Week 12
General activity subscale score based on the JKOM
Time frame: Baseline, Week 1, and Week 12
Health conditions subscale score based on the JKOM
Time frame: Baseline, Week 1, and Week 12
Number of participants showing an improvement of >= 1 grade in the JKOM questionnaire items
Time frame: Week 1 and Week 12
Serum interleukin-6 (IL-6) level
Time frame: Baseline and Week 12
Walking parameters evaluated by 10 m walk test
Time frame: Baseline and Week 12
Lower limb muscle strength parameters evaluated by LocomoScan G
Time frame: Baseline and Week 12
Number of stand-ups in the 30-second sit-to-stand test
Time frame: Baseline and Week 12
Body composition parameters
Time frame: Baseline and Week 12
Body composition parameters (body height)
Time frame: Baseline
Body composition parameters (body mass index (BMI))
Time frame: Baseline and Week 12
Changes from baseline in body composition parameters
Time frame: Baseline and Week 12
Percentage changes from baseline in body composition parameters
Time frame: Baseline and Week 12
Individuals who experienced adverse events
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
Time frame: Baseline and Week 12
Systolic and diastolic blood pressure
Time frame: Baseline and Week 12
Parameters evaluated by urinalysis
Time frame: Baseline and Week 12
Parameters evaluated by peripheral blood tests
Time frame: Baseline and Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No. Data sharing will be discussed among the research affiliates after the study is completed.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tsuyoshi Takara, MD study chair
Medical Corporation Seishinkai, Takara Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food containing NAG and HA and Food containing NAG in people with Healthy Japanese Individuals, run by Bloomage Biotechnology Corp., Ltd. at 2 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Naoko Suzuki (+81-3-3818-0610, group_gakujutsu@orthomedico.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee pain intensity evaluated by Visual Analogue Scale (VAS) (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.