Tokyo, Jan. 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060360) titled 'Effects of consumption of the test food on the shoulder joint' on Jan. 15.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - ICHIMARU PHARCOS Co., Ltd.
Condition:
Condition - Healthy Japanese
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To conduct exploratory verification of the effects of consumption of the test food on the shoulder joint
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Duration: 12 weeks
The test food
Interventions/Control_2 - Duration: 12 weeks
Placebo
Eligibility:
Age-lower limit - 40
years-old
=60 points) 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) and supplements
6. Individuals who are allergic to medicines and foods related to the test product, particularly those who are allergic to salmon or gelatin
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 (e.g., glucosamine hydrochloride, chondroitin, collagen peptide, hyaluronic acid, or DHA / EPA) that affect the joint
10. Individuals who plan to start exercise that put intense stress on the joint
11. Individuals who are judged as ineligible to participate in this study by the physician
Target Size - 20
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2025 Year 12 Month 10 Day
Date of IRB - 2025 Year 12 Month 10 Day
Anticipated trial start date - 2026 Year 01 Month 15 Day
Last follow-up date - 2026 Year 06 Month 25 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069055
Disclaimer: Curated by HT Syndication.