A Clinical Study for Evaluating the Safety of Long-Term Consumption and Excessive Consumption of Food Containing Plant Extract -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-

A Clinical Study for Evaluating the Safety of Long-Term Consumption and Excessive Consumption of Food Containing Plant Extract -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study- - A Clinical Study for Evaluating the Safety of Long-Term Consumption and Excessive Consumption of Food Containing Plant Extract

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000045431

Enrollment

Registered

2021-09-09

Start date

2021-09-10

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, 12 weeks consumption, 4 weeks excessive consumption Food not containing plant extract, 12 weeks consumption, 4 weeks excessive consumption

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Healthy males and females aged 20 to 64 years-old. (2) 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 and/or prescribed medications). (11) Subjects who drink excessive alcohol. (12) Subjects who can't stop drinking from one day before each measurement. (13) Subjects who are pregnant, planning to become pregnant or lactating during the current study period. (14) Subjects who are participating in other studies or planning to participate at the start of the current study. (15) Subjects who are judged as unsuitable for the current study by the investigator for other reasons.

Design outcomes

Primary

Measure	Time frame
Doctor's questions, Physical measurement, Physical examination, Blood test (Hematological test, Blood biochemical test), Urinalysis, Adverse event	—

Secondary

Measure	Time frame
Questionnaire	—

Countries

Japan

Contacts

Public ContactMakoto Terashima

Oneness support Co., Ltd. Clinical trial Division

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

Outcome results