A clinical study to evaluate the efficacy of high-blood pressure by continuous ingestion of food containing plant-derived ingredients with lifestyle management. (SBF-2024-06)

A clinical study to evaluate the efficacy of high-blood pressure by continuous ingestion of food containing plant-derived ingredients with lifestyle management. (SBF-2024-06) - A clinical study to evaluate the efficacy of high-blood pressure by continuous ingestion of food containing plant-derived ingredients with lifestyle management.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000056970

Enrollment

120

Registered

2025-02-09

Start date

2025-02-10

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

None listed

Interventions

Daily intake of test food with lifestyle management for 12 weeks Daily intake of control food with lifestyle management for 12 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Males and females who are >- 20 years old at the time of IC acquisition and <65 years old at the end of the study. (2) Subject, 130 mmHg <- SBP <- 159 mmHg, or 85 mmHg <- DBP <- 99 mmHg. (3) Those who have submitted written informed consent after fully understanding the purpose and content of this study.

Exclusion criteria

Exclusion criteria: (1) Those who systolic blood pressure is less than 90 mmHg. (2) Those who wish to become pregnant, are / might be pregnant or lactating during the study. (3) Those who are participating in other study or planning to participate or participated within the past 4 weeks. (4) Those who are; a) With disease on brain, heart, liver, kidney or other organs complications. b) Having a history of cardiovascular disease. c) Having a history of antihypertensive medication. d) With diabetes. e) With test food allergy. f) Having a history of serious illnesses such as cancer or tuberculosis. (5) Those who are undergoing some medical treatment at the time of the eligibility assessment test. (6) Those who regularly use medicines, quasi-drugs, foods for specified health uses, foods with functional claims, health foods, etc. that may affect the evaluation. (7) Those who heavy use of alcohol or smoke. (8) Those who have an unsteady lifestyle because of a working shift or a night shift. (9) Those who have regular hard exercise. (10) Those who are unable to improve their lifestyle or those who are making sufficient efforts. (11) Others who are judged inappropriate for participant by the investigator.

Design outcomes

Primary

Measure	Time frame
Blood pressure; Systolic blood pressure and Diastolic blood pressure	—

Secondary

Measure	Time frame
Lifestyle management	—

Countries

Japan

Contacts

Public ContactAyako Kidokoro

Suntory Beverage & Food Limited Development & Designed Department

Ayako_Kidokoro@suntory.co.jp050-1734-4524

Outcome results