A long term clinical study for safety evaluation of containing plant-extracts foods. (SME-2021-07) - A long term clinical study for safety evaluation of containing plant-extracts foods.

Suntory Beverage & Food Limited0 sites48 target enrollmentMarch 4, 2022

Conditionsot applicable

Overview

Phase: 未知
Intervention: Not specified
Conditions: ot applicable
Sponsor: Suntory Beverage & Food Limited
Enrollment: 48
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 4, 2022

End Date

July 9, 2022

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Suntory Beverage & Food Limited

Eligibility Criteria

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 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 to food e) having a history of cancer or tuberculosis f) positive or false\-positive by infectious disease test (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 late\-night workers. (16\) Others who are judged inappropriate for participant by the investigator.