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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000031180
Enrollment
15
Registered
2018-02-09
Start date
2018-02-14
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

Sponsors

Oneness support Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Healthy males and females aged 20 to 64 years-old. (2) Subjects whose BMI are under 30. (3) Subjects who can make self-judgment and are voluntarily giving written informed consent.

Exclusion criteria

Exclusion criteria: (1) Subjects who were diagnosed with serious disease (e.g., diabetes, liver disease, kidney disease, digestive disease, heart disease, respiratory disease and/or peripheral vascular disease). (2) Subjects with abnormal parameters in liver and/or kidney function. (3) Subjects who had a gastrointestinal surgery. (4) Subjects with a disease currently under treatment. (5) Subjects with drug or food allergies. (6) Subjects with anemic. (7) Subjects who play high intensity sports and/or are on a diet. (8) Subjects with irregular life patterns. (9) Subjects who can't stop using functional foods (including Food for Specified Health Uses or Foods with Function Claims) and/or Specified quasi-drugs during the current study periods. (10) Subjects who are under treatment with medications (including OTC or prescribed medication). (11) Subjects who drink excessive alcohol, or who can't stop drinking from one day before each measurement. (12) Subjects who are planning to become pregnant after imformed consent for the current study, pregnant or lactating. (13) Subjects who are participating in other studies or planning to participate during the current study period. (14) Subjects who are judged as unsuitable for the current study by the investigator for other reasons.

Design outcomes

Primary

MeasureTime frame
Doctor's questions, Physical measurement, Physical examination, Blood test (Hematological test, Blood biochemical test, Serum-immunological test), Urinalysis, Adverse event

Countries

Japan

Contacts

Public ContactMakoto Terashima

Oneness support Co., Ltd. Clinical trial Division

mterashima@oneness-sup.co.jp06-4801-8917

Outcome results

None listed

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