Effects of consumption of the test food on the knee cartilage markers in healthy Japanese

UMIN ID: UMIN000056216

Registered date:20/11/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy Japanese
• Date of first enrollment: 2024/11/20
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Duration: 16 weeks Test food: Proteoglycan derived from salmon nasal cartilage Administration: Take one tablet per day with water after dinner. *If you forget to take the test food, take it as soon as you remember. The daily dose should be taken within the day and not carried over to the next day.
Duration: 16 weeks Test food: Placebo Administration: Take one tablet per day with water after dinner. *If you forget to take the test food, take it as soon as you remember. The daily dose should be taken within the day and not carried over to the next day.

Outcome(s)

• Primary Outcome: 1. The measured value and the logarithmic value of procollagen II C-terminal propeptide (P2CP) at 16 weeks after intervention (16w) 2. The measured values and the logarithmic values of P2CP at 4, 8, and 12 weeks after intervention (4w, 8w, and 12w) 3. The measured values and the logarithmic values of Coll2-1, collagen type II cleavage (C2C), cartilage oligomeric matrix protein (COMP), and creatinine-corrected C-terminal telopeptides of type II collagen (CTx-II) at 4w, 8w, 12w, and 16w
• Secondary Outcome: 1. The measured values of the Japanese Orthopaedic Association (JOA) score (left/right averaged, left leg, and right leg), pain on walking (left/right averaged, left leg, and right leg), pain on ascending or descending stairs (left/right averaged, left leg, and right leg), range of motion (left/right averaged, left leg, and right leg), joint effusion, visual analogue scale (VAS), total score of the Japanese Knee Osteoarthritis Measure (JKOM), pain and stiffness in knees, conditions in daily life, general activities, and health conditions at 4w, 8w, 12w, and 16w 2. Individuals whose responses to each item in the JKOM improved by one or more scales at 4w, 8w, 12w, and 16w

Key inclusion & exclusion criteria

• Age minimum: 40years-old
• Age maximum: 70years-old
• Gender: Male and Female
• Exclude criteria: 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction 2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Individuals who are currently 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 who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 5. Individuals who are taking or using medications (including herbal medicines) and supplements 6. Individuals who are allergic to medicines or foods related to the test product 7. Individuals who are pregnant, lactating, or planning to become pregnant during this study 8. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study 9. Individuals who are judged as ineligible to participate in this study by the physician

Related Information

• Primary Sponsor: ORTHOMEDICO Inc.
• Secondary Sponsor: Medical Corporation Toujinkai, Nishi-Arai Ekimae Clinic Ophthalmology and Orthopedics Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
• Source(s) of Monetary Support: NIHON PHARMACEUTICAL CO.,LTD.