Safety confirmation test of overdose intake of foods containing Camellia Japonica seed extract

Not Applicable

• Conditions: Healthy adult

• Registration Number: JPRN-UMIN000038166
• Lead Sponsor: Oneness support Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-04
• Study Completion: 2019-12-09
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

(1) Subjects who were diagnosed with liver disease, kidney disease, gastrointestinal disease, heart disease, diabetes, or other diseases that may affect the results of this study, or who have a history of surgery (2) Subjects who indicate abnormal parameter in liver or kidney function (3) Subjects with a disease currently under treatment (4) Subjects with anemia (5) Subjects who detect abnormal values by blood test (6) Subjects who determine ineligible by principal investigator (7) Subjects with drug or food allergies (8) Subjects who play high intensity sports and/or are on a diet (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 with smoking habit (13) Subjects with irregular life patterns and lifestyle of reversal of day and night (14) Subjects who have a habit of excessive eating and drinking (15) Subject who has been pregnant or subject who have a plan to become pregnant or breast feed during the study period (16) Subjects who is participating in the other study or planning to participate during the study period (17) Subjects who has taken the blood sampling more than 200 mL within 1 month, or plan the blood sampling during the study period

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Body measurement, physical examination Hematology test Blood biochemistry test Urinalysis Doctor's questions Assess these at screening (before intake), at 2 and 4 weeks after intake.