A verification study of the reduction effect of the test food consumption on blood pressure

A verification study of the reduction effect of the test food consumption on blood pressure: a randomized, placebo-controlled, double-blind, parallel-group comparison study - A verification study of the reduction effect of the test food consumption on blood pressure

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000051047

Enrollment

Registered

2023-05-12

Start date

2023-05-12

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Japanese subjects

Interventions

Duration: 12 weeks Test food: Active tablet Administration: Take one tablet with water before every meals. In total three tablets a day, taken three times daily. *If you forget to take the test f

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy subjects 5. Subjects who are between 130 mmHg or more and 139 mmHg or less in systolic blood pressure at screening (before test-food consumption; Scr) 6. Subjects who are no more than 89 mmHg in diastolic blood pressure at Scr 7. Subjects who are judged as eligible to participate in the study by the physician

Exclusion criteria

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 currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily 5. Subjects who are 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 are a smoker 8. Subjects who are pregnant, lactating, or planning to become pregnant during this trial 9. 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 10. Subjects who are judged as ineligible to participate in this study by the physician

Design outcomes

Primary

Measure	Time frame
1. The measured value of systolic blood pressure at 12 weeks after consumption (12w)	—

Secondary

Measure	Time frame
1. The amount of changes from screening (before test-food consumption; Scr) in systolic blood pressure at 12w 2. The measured value of systolic blood pressure at four and eight weeks after consumption (4w and 8w), and the amount of changes from Scr 3. The measured values of diastolic blood pressure at 4w, 8w, and 12w, and the amount of changes from Scr 4. The subjects who have 129 mmHg or less of systolic blood pressure and 89 mmHg or less of diastolic blood pressure at 12w	—

Measure

Time frame

1. The amount of changes from screening (before test-food consumption; Scr) in systolic blood pressure at 12w 2. The measured value of systolic blood pressure at four and eight weeks after consumption (4w and 8w), and the amount of changes from Scr 3. The measured values of diastolic blood pressure at 4w, 8w, and 12w, and the amount of changes from Scr 4. The subjects who have 129 mmHg or less of systolic blood pressure and 89 mmHg or less of diastolic blood pressure at 12w

—

Countries

Japan

Contacts

Public ContactNaoko Suzuki

ORTHOMEDICO Inc. R&D Department

nao@orthomedico.jp03-3818-0610

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026