Tokyo, Oct. 4 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059281) titled 'Effects of test food consumption on the knee joint in healthy Japanese' on Oct. 3.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - MYCARE Co., Ltd.
Condition:
Condition - Healthy Japanese
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To verify the effects of test food consumption on the knee joint in healthy Japanese.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Duration: 12 weeks
Test product: Test food
Interventions/Control_2 - Duration: 12 weeks
Test product: Placebo food
Eligibility:
Age-lower limit - 20
years-old
= 66 mm
7. Individuals with low "Conditions in daily life" score of the JKOM
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 shrimp or crab
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 regularly consume "Foods for Specified Health Uses" or "Foods with Functional Claims" (e.g., N-acetylglucosamine, salmon nasal cartilage-derived proteoglycan or undenatured type II collagen, glucosamine hydrochloride, curcumin, skipjack-derived elastin peptide, or collagen peptides)
10. Individuals who engage in intense, 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 who may require their use during the study period
12. Individuals who are judged as ineligible to participate in this study by the physician
Target Size - 166
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2025 Year 09 Month 10 Day
Date of IRB - 2025 Year 09 Month 10 Day
Anticipated trial start date - 2025 Year 10 Month 03 Day
Last follow-up date - 2026 Year 05 Month 06 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067813
Disclaimer: Curated by HT Syndication.