Tokyo, June 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061969) titled 'Effects of consumption of the test food on nighttime blood pressure' on June 19.

Study Type: Interventional

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

Primary Sponsor: Institute - Toyo Sugar Refining Co., Ltd.

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

Objective: Narrative objectives1 - To verify the effects of consumption of the test food on nighttime blood pressure in healthy adults Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Duration: 12 weeks Test product: Capsule containing food Administration: Consume one tablet three times daily (breakfast, lunch, and dinner, in total three tablets a day) with water. *If a take is missed, it should be consumed on an empty stomach as soon as remembered. The daily take 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: Capsule not containing food (placebo food) Administration: Consume one tablet three times daily (breakfast, lunch, and dinner, in total three tablets a day) with water. *If a take is missed, it should be consumed on an empty stomach as soon as remembered. The daily take should be consumed within the same day and should not be carried over to the following day.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Japanese

2. Men or women

3. Adults

4. Healthy individuals

5. Individuals whose systolic blood pressure measured in the examination room during day-time hours is less than 160 mmHg

6. Individuals whose systolic blood pressure measured in the examination room during day-time hours is less than 100 mmHg

7. Individuals whose average systolic blood pressure (measured at home at night over a 3-day period) is less than 120 mmHg

8. Individuals whose average systolic blood pressure (measured at home at night over a 3-day period) is less than 70 mmHg

9. Individuals with a small decrease in systolic blood pressure from daytime to nighttime (4 hours after falling asleep) 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 consume Foods for Specified Health Uses or Foods with Functional Claims

5. Individuals who are a smoker

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

7. Individuals who are allergic to medications or foods related to the test product, particularly those allergic to citrus fruit

8. 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)}

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

10. Individuals who plan to have surgery within two weeks before the agreement to participate in this study or two weeks after this study

11. Individuals who are deemed unsuitable for participation in this study by the principal investigator Target Size - 60

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 05 Month 13 Day Date of IRB - 2026 Year 05 Month 13 Day Anticipated trial start date - 2026 Year 06 Month 19 Day Last follow-up date - 2027 Year 02 Month 22 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070881

Disclaimer: Curated by HT Syndication.