Healthy adults
Conditions
Interventions
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
Sponsors
Toyo Sugar Refining Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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)
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured values of systolic blood pressure [4 hours after going to sleep] at 12 weeks after consumption (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured values of systolic blood pressure [2:00 a.m.], systolic blood pressure [4:00 a.m.], systolic blood pressure [2:00 a.m. - daytime], systolic blood pressure [4:00 a.m. - daytime], systolic blood pressure [4h after going to sleep - daytime], diastolic blood pressure [2:00 a.m.], diastolic blood pressure [4:00 a.m.], diastolic blood pressure [4h after going to sleep], diastolic blood pressure [2:00 a.m. - daytime], diastolic blood pressure [4:00 a.m. - daytime], diastolic blood pressure [4h after going to sleep - daytime], heart rate [2 a.m.], heart rate [4 a.m.], and heart rate [4h after going to sleep] at 12w 2. The change and percentage change of systolic blood pressure [2:00 a.m.], systolic blood pressure [4:00 a.m.], systolic blood pressure [4h after going to sleep], systolic blood pressure [2:00 a.m. - daytime], systolic blood pressure [4:00 a.m. - daytime], systolic blood pressure [4h after going to sleep - daytime], diastolic blood pressure [2:00 a.m.], diastolic blood pressure [4:00 a.m.], diastolic blood pressure [4h after going to sleep], diastolic blood pressure [2:00 a.m. - daytime], diastolic blood pressure [4:00 a.m. - daytime], diastolic blood pressure [4h after going to sleep - daytime], heart rate [2 a.m.], heart rate [4 a.m.], and heart rate [4h after going to sleep] at 12w from screening (Scr) 3. Individuals who experienced adverse events 4. Individuals whose values of urinalysis and peripheral blood test are outside the reference range after intervention despite within the reference range at Scr 5. Physical measurements, urinalysis, and peripheral blood test | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed