Tokyo, Oct. 4 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059282) titled 'Effects of test food consumption on vascular function 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 - BIOCON (JAPAN) LTD.

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

Objective: Narrative objectives1 - To verify the effects of test food consumption on vascular function in healthy Japanese. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Duration: 12 weeks Test product: Supplement containing horse-derived elastin peptides Administration: Two tablets per day, taken between lunch and bedtime Interventions/Control_2 - Duration: 12 weeks Test product: Placebo Administration: Two tablets per day, taken between lunch and bedtime

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 = 4% and < 7% at screening 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 drink to excess (average of more than about 20 g/day as absolute alcohol intake) {500 mL: a medium bottle of beer or about 1.5 cans of canned chu-hi, 180 mL: 1 go of sake or about 1.5 glasses of wine, 90 mL: half-go with shochu, 60 mL: a glass of whiskey brandy (double)} every day

8. Individuals who are pregnant, lactating, or planning to become pregnant during this study

9. 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

10. 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 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 03 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067814

Disclaimer: Curated by HT Syndication.