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Study on blood pressure lowering power of health food

An uncontrolled open-label pre- and post-comparison study on usefulness of foods labeled with antihypertensive function and the characterization of the useful population for high normal and elevated blood pressure - Usefulness of foods with antihypertensive function on prehypertension

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000041524
Enrollment
150
Registered
2021-01-01
Start date
2021-02-20
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

Prehypertension

Interventions

Foods containing piperine once a day for 4 weeks or Food containing sardine peptide, once a day for 4 weeks or Acetic acid-containing beverage, once a day for 4 weeks

Sponsors

Okayama University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. SBP ranging from 120 to 160 mmHg in examination room during screening before obtaining consent 2. Mean home SBP after waking up will be from 115 to 145 mmHg in the pre-observation period 3. Those who are 20 years of age or older at the time of obtaining consent 4. Those who have given their free written consent after receiving sufficient explanation for participation in this research

Exclusion criteria

Exclusion criteria: 1. Those who have been diagnosed as hypertension 2. Normal BP: examination room; less than120 (SBP) and 80 (DBP), home; less than115 (SBP) and 75 (DBP) 3. Those who have started one or more of diet, exercise, and/or drug therapy for hypertension 4. At the time of screening before obtaining consent, those who show hypertension criteria in the examination room blood pressure above Grade II hypertension 5. Those who have an average home blood pressure of 145-159 and/or 90-99 mmHg or higher after waking up during the previous observation period 6. Those who have any of histories of cerebral cardiovascular disease, nonvalvular atrial fibrillation, diabetes, or CKD with urinary protein, or who possessing three or more of the following: 65 years or older, male, dyslipidemia, smoking even if the mean home blood pressure after waking up will be elevated blood pressure (125-134 and/or 75-84 mmHg) or Grade I hypertension (135-144 and/or 85-89 mmHg) during the pre-observation period 7. Those with suspected secondary hypertension caused by CKD, endocrine disorders, sleep apnea syndrome, drug treatment 8. Patients with an uncontrolled diabetes 9. Patients with a history of myocardial infarction or unstable angina

Design outcomes

Primary

MeasureTime frame
Compare the difference of the average SBP value after waking up during the last week (3-4 weeks) of the test food intake period with the average value during the previous observation period for each subject.

Countries

Japan

Contacts

Public ContactNoritaka Ariyoshi

Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences

pmaphs.OU@gmail.com086-235-6619

Outcome results

None listed

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