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

NCT07729657 | Not Yet Recruiting DMC

• 1 other identifier: 11127-0045-34
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy Japanese Individuals

Keywords

Knee discomfort; Physical function; Muscle mass

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (20)

• Total score based on the JKOM

  Baseline, Week 1, and Week 12

• Knee pain and stiffness subscale score based on the JKOM

  Baseline, Week 1, and Week 12

• Condition of daily life subscale score based on the JKOM

  Baseline, Week 1, and Week 12

• General activity subscale score based on the JKOM

  Baseline, Week 1, and Week 12

• Health conditions subscale score based on the JKOM

  Baseline, Week 1, and Week 12

Study Arms (4)

NAG + HA + PQQ group

ACTIVE COMPARATOR

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

NAG + HA group

ACTIVE COMPARATOR

Participants in this arm will consume the active study product containing NAG and HA.

Dietary Supplement: Food containing NAG and HA

NAG group

ACTIVE COMPARATOR

Participants in this arm will consume the active study product containing NAG.

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.

Dietary Supplement: Placebo

Interventions

Food containing NAG, HA, and PQQ DIETARY_SUPPLEMENT

Take 3 capsules with water daily for 12 weeks.

NAG + HA + PQQ group

Food containing NAG and HA DIETARY_SUPPLEMENT

Take 3 capsules with water daily for 12 weeks.

NAG + HA group

Food containing NAG DIETARY_SUPPLEMENT

Take 3 capsules with water daily for 12 weeks.

NAG group

Placebo DIETARY_SUPPLEMENT

Take 3 capsules with water daily for 12 weeks.

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Bloomage Biotechnology Corp., Ltd.: lead
• Orthomedico Inc.: collaborator
• WORSO.Co.,Ltd: collaborator

Study Sites (2)

Nerima Medical Association Minami-machi Clinic

Nerima-ku, Tokyo, 176-0002, Japan

Location

Medical Corporation Seishinkai, Takara Clinic

Shinagawa-ku, Tokyo, 141-0022, Japan

Location

Study Officials

• Tsuyoshi Takara, MD

  Medical Corporation Seishinkai, Takara Clinic

  STUDY CHAIR

Central Study Contacts

Naoko Suzuki

CONTACT

+81-3-3818-0610; group_gakujutsu@orthomedico.jp

Asami Baba, PhD

CONTACT

+81-3-3818-0610; asami-baba@orthomedico.jp

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 27, 2026
• Study Start: July 30, 2026
• Primary Completion (Estimated): December 14, 2026
• Study Completion (Estimated): December 14, 2026
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

JP (2)