Tokyo, Oct. 28 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059552) titled 'Effects of consumption of the test food on the knee joint in healthy Japanese' on Oct. 27.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - BIOCON (JAPAN) LTD.

Condition: Condition - Healthy Japanese Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To survey the effects of consumption of the test food on the knee joint in healthy Japanese. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Duration: 12 weeks Test product: Supplement containing elastin peptides derived from horse Administration: Consume two capsules per day after lunch and before sleep Interventions/Control_2 - Duration: 12 weeks Test product: Placebo capsule Administration: Consume two capsules per day after lunch and before sleep

Eligibility: Age-lower limit - 40 years-old

Gender - Male and Female Key inclusion criteria - 1. Japanese

2. Men or women

3. Adults (aged >= 40 and < 75 years)

4. Healthy individuals

5. Individuals who are judged in the Kellgren-Lawrence grade (KL grade) as 0 or 1 in X-ray at screening (Scr)

6. Individuals whose score of the JKOM measured by Visual Analogue Scale: (VAS) is high at Scr Key exclusion 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) or supplements

6. Individuals who are allergic to medicines or foods related to the test product, particularly those who are allergic to horse-derived substances

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 usually use "Foods for Specified Health Uses," or "Foods with Functional Claims" {e.g. N-acetylglucosamine, proteoglycan from salmon nasal cartilage (SNC), undenatured type II collagen from SNC, glucosamine hydrochloride, curcumin, elastin peptide from skipjack, or collagen peptide}

10. Individuals who engage in intense, knee joint-loading exercise (e.g., ball sports such as soccer, baseball, basketball, or jogging, running, skiing, or snowboarding)

11. Individuals who use a cane or joint support, or may use them during this study

12. Individuals who are judged as ineligible to participate in this study by the physician Target Size - 14

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 10 Month 22 Day Date of IRB - 2025 Year 10 Month 22 Day Anticipated trial start date - 2025 Year 10 Month 27 Day Last follow-up date - 2026 Year 04 Month 09 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068117

Disclaimer: Curated by HT Syndication.