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

Not Yet RecruitingNA

Sponsor: Bloomage Biotechnology Corp., Ltd.

Conditions: Healthy Japanese Individuals

Interventions: Food containing NAG, HA, and PQQ, Food containing NAG and HA, Food containing NAG, Placebo

Countries: Japan

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (2)

Nerima-ku, Tokyo, Japan
Shinagawa-ku, Tokyo, Japan