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Effect of Daily Ingestion of the Test Food on Improving Vascular Endothelial Function: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study

Effect of Daily Ingestion of the Test Food on Improving Vascular Endothelial Function: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study - Beneficial Effect of the Test Food on Improving Vascular Endothelial Function.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000048020
Enrollment
36
Registered
2022-06-15
Start date
2022-07-07
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 Adult

Interventions

Sponsors

Hokkaido Information University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Subjects who agree to participate in this study with a written informed consent. 2. Japanese males and postmenopausal females between 40 and 65 years old. 3. Subjects whose FMD values are relatively low.

Exclusion criteria

Exclusion criteria: 1. Subjects with difficulty measuring flow- mediated dilation. 2. Subjects whose BMI is >=30 kg/m2. 3. Subjects who are under physician's advice, treatment, and/or medication for hypertension, dyslipidemia and/or diabetes. 4. Subjects with implantable electronic medical devices. 5. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities. 6. Subjects with major surgical history relevant to the digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc. 7. Subjects with unusually high and/or low blood pressure and/or abnormal hematological data. 8. Subjects with severe anemia. 9. Pre- or post-menopausal women complaining of obvious physical changes. 10. Subjects who are at risk of having allergic reactions to drugs or foods. 11. Subjects who regularly take medicine, functional foods, and/or supplements which would affect blood vessel function and/or blood pressure. 12. Smokers, alcohol addicts or subjects with disordered lifestyle. 13. Subjects who donated either 400 ml whole blood within 16 wks (women), 12 wks (men), 200 ml whole blood within 4 wks, or blood components within 2 wks, prior to this study. 14. Pregnant or lactating women or women who expect to be pregnant. 15. Subjects who currently participate in other clinical trials, or participated within the last 4 wks prior to this study. 16. Any other medical and/or health reasons unfavorable to participation in this study, as judged by the principal investigator.

Design outcomes

Primary

MeasureTime frame
Flow-mediated dilation

Secondary

MeasureTime frame
Sleep and stress questionnaires, home blood pressure

Countries

Japan

Contacts

Public ContactNaoyuki HONMA

Hokkaido Information University Health Information Science Center

hisc-acad.res@s.do-johodai.ac.jp011-385-4430

Outcome results

None listed

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