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Effect of Daily Ingestion of the Plum Extract on the Improvement of Blood Pressure: a randomized, double-blind, placebo-controlled, parallel group comparison study

Effect of Daily Ingestion of the Plum Extract on the Improvement of Blood Pressure: a randomized, double-blind, placebo-controlled, parallel group comparison study - Effect of Daily Ingestion of the Plum Extract on the Improvement of Blood Pressure

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000023184
Enrollment
72
Registered
2016-07-15
Start date
2016-07-28
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 adults

Interventions

Ingestion of the plum extract-processed food (30 g) daily for 12 weeks Ingestion of the placebo food (30 g) daily for 12 weeks

Sponsors

Hokkaido Information University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Subjects whose hospital SBP is >=130 mmHg and <160 mmHg. 2. Subjects who agree to participate in the current study with a written informed consent.

Exclusion criteria

Exclusion criteria: 1. Subjects who are under treatment and medication for hypertension. 2. Subjects with serious cerebrovascular, cardiac, hepatic, renal, and / or gastrointestinal diseases, or affected with an infectious disease which is required to report to the authorities. 3. Subjects who have a major surgical history related to digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc. 4. Subjects with unusually high and/or low blood pressure or abnormal hematological data 5. Subjects with serious anemia. 6. Pre- or post-menopausal subjects having complaints of obvious physical changes. 7. Subjects who are at risk of having allergic reactions to drugs or foods (especially plum, fruits of the family Rosacea and/or white birch pollen). 8. Subjects regularly take medicine, functional foods and/or supplements (peptide, acetic acid, GABA, geniposidic acid, flavonoids, sesamin, chlorella, olive leaves, garlics, dietary fiber, tomatoes, folic acid, long pepper extract, etc.) which would affect the blood pressure. 9. Heavy smokers, alcohol addicts or subjects with irregular lifestyle. 10. Subjects who donated either 400ml whole blood within 12 weeks (men) /16 weeks (women) or 200ml whole blood within 4 weeks or blood components within 2 weeks prior to this study. 11. Subjects who are pregnant or expected to be pregnant, or lactating during the study. 12. Subjects who participate in other clinical trials within the last one month prior to the current clinical trial. 13. Any other medical reasons judged by the principal investigator.

Design outcomes

Primary

MeasureTime frame
systolic pressure and diastolic pressure at 4 weeks, 8 weeks and 12 weeks after the beginning of ingestion of test meals and at 2 weeks after the end of ingestion of test meals

Secondary

MeasureTime frame
peripheral blood flow, TC, HDL-C, LDL-C, TG, fasting plasma glucose, HbA1c, platelet aggregation, defecation frequency, VAS questionnaire

Countries

Japan

Contacts

Public ContactDir. Prof. Jun NISHIHIRA, M.D., Ph.D.

Hokkaido Information University Center of Health Information Science

nishihira@do-johodai.ac.jp011-385-4430

Outcome results

None listed

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