UMIN ID: UMIN000056970
Registered date:09/02/2025
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)
Basic Information
| Recruitment status | Pending |
|---|---|
| Health condition(s) or Problem(s) studied | Not applicable |
| Date of first enrollment | 2025/02/10 |
| Target sample size | 120 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Daily intake of test food with lifestyle management for 12 weeks Daily intake of control food with lifestyle management for 12 weeks |
Outcome(s)
| Primary Outcome | Blood pressure; Systolic blood pressure and Diastolic blood pressure |
|---|---|
| Secondary Outcome | Lifestyle management |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 65years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude 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. |
Related Information
| Primary Sponsor | Suntory Beverage & Food Limited |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | None |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Ayako Kidokoro |
| Address | 13-2 Imaikami-cho, Nakahara-ku, Kawasaki, Kanagawa, JAPAN Japan 2110067 |
| Telephone | 050-1734-4524 |
| Ayako_Kidokoro@suntory.co.jp | |
| Affiliation | Suntory Beverage & Food Limited Development & Designed Department |
| scientific contact | |
| Name | Toshihiro Maekawa |
| Address | 13-2 Imaikami-cho, Nakahara-ku, Kawasaki, Kanagawa, JAPAN Japan |
| Telephone | 050-1804-0276 |
| Toshihiro_Maekawa@suntory.co.jp | |
| Affiliation | Suntory Beverage & Food Limited Development & Designed Department |