Effects of consumption of the test food on blood pressure

Not Applicable

• Conditions: Healthy Japanese subjects

• Registration Number: JPRN-UMIN000045732
• Lead Sponsor: ORTHOMEDICO Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-12
• Study Completion: 2022-03-05
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Not provided

Exclusion Criteria

1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects who currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage in daily use 5. Subjects who currently taking medications (including herbal medicines) and supplements 6. Subjects who are allergic to medicines and/or the test food related products 7. Subjects who suffer from coronavirus disease 2019 (COVID-19) 8. Subjects who are smokers 9. Subjects who are pregnant, lactation, or planning to become pregnant 10. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 11. Subjects who are judged as ineligible to participate in the study by the physician

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. The measured value of sitting systolic blood pressure (SSBP) at 12 weeks after the start of test-food consumption (12w)

Secondary Outcome Measures

Name	Time	Method
1. The measured values of SSBP at four and eight weeks after consumption (4w, 8w) 2. The measured values of sitting diastolic blood pressure (SDBP) at 4w, 8w and 12w 3. The ratio of number of subjects who are SSBP 129 mmHg or less and SDBP 89 mmHg or less at 12w 4. The measured values of SSBP, SDBP and Total Area Under the Curve (tAUC) at before consumption and each subsequent measurement points (30, 60, 90, 120, 150 180 minutes after taking the test food)