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Safety evaluation study of food containing plant extract

Phase 1
Conditions
Healthy adults
Registration Number
JPRN-UMIN000040970
Lead Sponsor
Kanazawa Medical University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
24
Inclusion Criteria

Not provided

Exclusion Criteria

1) Subjects who have an allergy to the test food. 2) Subjecte whose GDS score is more than 10 before intake of the test food. 3)Subjects who has participated in other clinical studies (clinical trials) within 3 months before the start of the test or who is planning to participate in other clinical studies (clinical trials) during the study period. 4) Subjects who is current disease or a history of diabetes, liver disease (hepatitis), renal disease, serious diseases such as heart disease, thyroid disease, adrenal disease, or other metabolic diseases. 5)Subjects who are judged as unsuitable for the study by principal investigator or sub-investigator.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Side effects and adverse events (Physical measurements, blood tests, urinalysis, vitals, doctor consultation)
Secondary Outcome Measures
NameTimeMethod
RBMT(The Rivermead Behavioral Memory Test)
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