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A Study on the Effect of Food Containing Plant Extract on Vascular Endothelial Function. -A Ramdomized, Double-blind, Placebo-controlled, Parallel-group Study-

A Study on the Effect of Food Containing Plant Extract on Vascular Endothelial Function. -A Ramdomized, Double-blind, Placebo-controlled, Parallel-group Study- - A Study on the Effect of Food Containing Plant Extract on Vascular Endothelial Function.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000036602
Enrollment
40
Registered
2019-05-06
Start date
2019-05-07
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

None listed

Interventions

Food containing plant extract, 8 weeks consumption. Food not containing plant extract, 8 weeks consumption.

Sponsors

KSO Corporation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Healthy males and females aged 40 to 64 years-old. (2) Subjects whose BMI are less than 30. (3) Subjects who can make self-judgment and are voluntarily giving written informed consent.

Exclusion criteria

Exclusion criteria: (1) Subjects who contract chronic disease and are under treatment. (2) Subjects who can't stop using medicines, quasi-drugs, supplements and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims) affecting blood pressure, lipid metabolism, blood sugar level, body fat, and so on during test periods. (3) Subjects who have a history of and/or contract serious diseases (eg, liver disease, kidney disease, digestive disease, heart disease, respiratory disease, endocrine disease, thyroid disease, adrenal disease and/or metabolic disease). (4) Subjects who have a history and/or a surgical history of digestive disease affecting digestion and absorption. (5) Subjects who are judged as unsuitable for the current study by screening tests. (6) Subjects who are diagnosed as arrhythmia by the screening tests. (7) Subjects who are shiftworker and/or midnight-shift worker. (8) Subjects who have declared allergic reaction to ingredients of test foods. (9) Subjects who have excessive alcohol intake more than approximately 60 g/day of pure alcohol equivalent or habit of drinking not less than 5 days a week. (10) Subjects who have a history of and/or contract drug addiction and/or alcoholism. (11) Subjects who can't stop drinking from 2 days before each measurement. (12) Subjects who have been pregnant or have a plan to become pregnant, or breast feed during the study period. (13) Subjects who have donated over 200 mL of blood and/or blood components within the last one month prior to the current study or over 400 mL of blood and/or blood components within the last three months prior to the current study. (14) Subjects who are planning to participate and/or had participated in other clinical studies within the last one month prior to the current study. (15) Subjects who are judged as unsuitable for the current study by the investigator for other reasons.

Design outcomes

Primary

MeasureTime frame
FMD

Countries

Japan

Contacts

Public ContactYoshika Komori

KSO Corporation Sales department

yoshi@kso.co.jp03-3452-7733

Outcome results

None listed

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