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

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

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.

Interventions

• Dietary supplement Food containing NAG, HA, and PQQ
  Take 3 capsules with water daily for 12 weeks.
• Dietary supplement Food containing NAG and HA
  Take 3 capsules with water daily for 12 weeks.
• Dietary supplement Food containing NAG
  Take 3 capsules with water daily for 12 weeks.
• Dietary supplement Placebo
  Take 3 capsules with water daily for 12 weeks.

Primary outcome measures

• Knee pain intensity evaluated by Visual Analogue Scale (VAS) [Time frame: Baseline and Week 12]

Secondary outcome measures (12)

• 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]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Prevention

Study locations

Japan · 2 centers

• Nerima Medical Association Minami-machi Clinic — Nerima-ku
• Medical Corporation Seishinkai, Takara Clinic — Shinagawa-ku

Identifiers

NCT: NCT07729657 · 11127-0045-34

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗