Tokyo, July 11 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062203) titled 'Effects of test food consumption on vascular endothelial function in healthy Japanese: a randomized, placebo-controlled, double-blind, parallel-group comparison study' on July 10.

Study Type: Interventional

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

Primary Sponsor: Institute - Horphag Research (Asia) Limited

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

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

Intervention: Interventions/Control_1 - Duration: 12 weeks Test product: Food containing Pycnogenol (R) Administration: Consume two capsules once per day with water

*If a dose is missed, it should be consumed as soon as remembered. The daily dose should be consumed within the same day and should not be carried over to the following day. Interventions/Control_2 - Duration: 12 weeks Test product: Starch (Placebo) Administration: Consume two capsules once per day with water

*If a dose is missed, it should be consumed as soon as remembered. The daily dose should be consumed within the same day and should not be carried over to the following day.

Eligibility: Age-lower limit - 40 years-old = Gender - Male and Female Key inclusion criteria - 1. Japanese

2. Men or women

3. Individuals aged 40-64 years

4. Healthy individuals

5. Individuals whose FMD is >= 4% and < 7% at screening Key exclusion criteria - 1. Individuals who are receiving treatment for or have a history of malignant tumors, heart failure, or myocardial infarction

2. Individuals who have an implanted pacemaker or implantable cardioverter defibrillator

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 receive hormonal therapy

5. Individuals who consume Foods for Specified Health Uses or Foods with Functional Claims

6. Individuals who consume foods or beverages containing functional ingredients that may influence vascular endothelial function (e.g., procyanidins, lactotripeptides, black soybean polyphenols, or elastin peptides)

7. Individuals who are taking or using medications (including herbal medicines) or supplements

8. Individuals who are allergic to medications or foods related to the test product, especially those who are allergic to pine trees

9. Individuals whose working form is irregular

10. Individuals who engage in intense exercise

11. 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

12. Individuals who are pregnant, lactating, or planning pregnancy during this study

13. Individuals who are deemed unsuitable for participation in this study by the principal investigator Target Size - 120

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 06 Month 10 Day Date of IRB - 2026 Year 06 Month 10 Day Anticipated trial start date - 2026 Year 07 Month 10 Day Last follow-up date - 2027 Year 03 Month 08 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071177

Disclaimer: Curated by HT Syndication.