A study to evaluate the safety of excessive intake of test food in a healthy adult subject

A study to evaluate the safety of excessive intake of test food in a healthy adult subject - A study to evaluate the safety of excessive intake of test food in a healthy adult subject

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000038180

Enrollment

Registered

2019-10-02

Start date

2019-10-07

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

Oral intake of the test product with a plant extract (10 tablets per day

4 weeks)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Healthy adult males and females from 20 to 64 years of age. (2)Subjects who participate in this study with a written informed consent.

Exclusion criteria

Exclusion criteria: (1) Subjects who receive a drug treatment (2) Subjects who have a history of serious disorder (heart disease, liver disease, kidney, digestive system disease, or et al.) (3) Females who have diagnosed pregnancy or is breast-feeding (4) Subjects who have medication or food allergy (5) Subjects who have excessive alcohol-drinking (6) Subjects who have extremely irregular dietary habits (7) Subjects who are participating in other trial, have participated in the past 4 weeks, or plan to participate in other trial during scheduled period in this trial (8) Subjects who have made a blood donation of 200 mL within the last one month prior to this study (9) Male subjects who have made a blood donation of 400 mL within the last three months prior to this study (10) Female subjects who have made a blood donation of 400 mL within the last four months prior to this study (11) Male subjects who have made a blood donation over an amount (1,200 mL minus the estimated volume of blood sampling during the study) within the last one year prior to this study (12) Female subjects who have made a blood donation over an amount (800 mL minus the estimated volume of blood sampling during the study) within the last one year prior to this study (13) Subjects judged as unsuitable for the study by the investigators

Design outcomes

Primary

Measure	Time frame
Incidence of adverse events and side effects	—

Secondary

Measure	Time frame
(1) Physical measurement (Body weight, Body mass index, body fat percentage) (2) Physical examination (3) Blood biochemical test (4) Hematological test (5) Urinalysis	—

Countries

Japan

Contacts

Public ContactRyusei Uchio

House Wellness Foods Corporation Research and Development Institute

Uchio_Ryusei@house-wf.co.jp072-778-1127

Outcome results