A clinical study to evaluate the safety of plant-extracts containing foods. (SME-2021-04-FOSHUS)

Not Applicable

• Conditions: ot applicable

• Registration Number: JPRN-UMIN000045671
• Lead Sponsor: SUNTORY MONOZUKURI EXPERT LIMITED

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-06
• Study Completion: 2021-12-16
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

(1) Those with systolic blood pressure less than 90 mmHg at the start of ingestion (2) Women who are/might be pregnant or lactating during the study (3) Those who have taken >=200 mL whole blood or blood donation within 4 weeks before the start of the intake (4) Men who have taken =>400 mL whole blood within 12 weeks before the start of intake (5) Women who have taken =>400 mL whole blood within 16 weeks before the start of intake (6) Men who have taken =>1,200 mL whole blood total (including the sampling of this study) within 12 months before the start of intake (7) Women who have taken =>800 mL whole blood total (including the sampling of this study) within 12 months before the start of intake (8) Those who are participating in other clinical study or planning to participate or participated within the past 4 weeks (9) Those who meet any of the following: (a) suffering from heart, liver, or kidney disease (including complications of other diseases) (b) having a history of cardiovascular disease (c) diabetes (d) allergic or highly sensitive to the test food (10) Those who are receiving any treatment at the time of screening (11) Those who regularly use pharmaceuticals (including quasi-drugs), foods for specified health use, foods with functional claims or health foods (12) Those who smoke an average of 21 or more cigarettes in a day (13) Those who drink an average of more than 60 g of pure alcohol in a day (14) Those who have an extremely irregular eating habit (15) Shift workers or midnight shift workers (16) Others who are judged inappropriate for participant by the investigators

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse reaction

Secondary Outcome Measures

Name	Time	Method
Adverse event Laboratory test value, Physical examination result