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A Clinical Study for Evaluating the Safety of Excessive Consumption of Food containing Pueraria Flower Extract -Open Study-

A Clinical Study for Evaluating the Safety of Excessive Consumption of Food containing Pueraria Flower Extract -Open Study- - A Clinical Study for Evaluating the Safety of Excessive Consumption of Food containing Pueraria Flower Extract

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000023476
Enrollment
50
Registered
2016-08-05
Start date
2016-08-19
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

No (Subjects under 30 of BMI)

Interventions

Food containing pueraria flower extract, 5-fold quantity of recommended daily intake

Sponsors

KSO Corporation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Healthy males and females whose age are from 20 to 64, and BMI are under 30. (2) Subjects who can make self-judgment and are voluntarily giving written informed consent.

Exclusion criteria

Exclusion criteria: (1) Subjects who are under medical treatment. (2) Subjects who contract or are under treatment for serious diseases (e.g., kidney disease, liver disease, heart disease, respiratory disease, endocrine disease, and/or metabolic disorder). (3) Subjects who can't stop using supplements and/or functional foods (including Food for Specified Health Uses and/or Foods with Function Claims) during test periods. (4) Subjects who can't stop drinking from 2 days before each measurement. (5) Subjects who have declared allergic reaction to ingredients of test foods. (6) Subjects who are planning to become pregnant after informed consent for the current study, are pregnant or lactating. (7) Subjects who are under treatment for or have a history of drug addiction and/or alcoholism. (8) Subjects who are shiftworker and/or midnight-shift worker. (9) Subjects who are planning to participate and/or had participated in other clinical studies within the last one month prior to the current study. (10) Subjects who are judged as unsuitable for the current study by the investigator for other reasons.

Design outcomes

Primary

MeasureTime frame
Biochemical examination, Hematological examination, urine analysis, vital signs

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