Safety assessment and consumption effects of cashew leaf extract capsules(single dose) on stress hormone, stress response and quality of life of male with shift work

Phase 1

Completed

• Conditions: Healthy conditions; Cashew leaf extract; Male with shift work; Stress hormone; Stress response

• Registration Number: TCTR20200128001
• Lead Sponsor: MARK ONE INNOVATION CENTER COMPANY LIMITED.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-28
• Study Completion: 2020-03-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 46

Inclusion Criteria

-Male with shift work aged between 25-55 years old
-ISMA Stress Questionnaire scores >14

Exclusion Criteria

-Diagnosed with cardiovascular diseases, respiratory diseases, neuropsychological diseases, head injury, diabetes mellitus, liver disease, cancer, autoimmune diseases and hematological disorder
-Smoking more than 10 pieces/day
-Alcohol addiction
-Volunteers who require supplements or herbs or drugs at least 1 months before participating in this study and during the trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Salivary Cortisol 2 hours Elisa method

Secondary Outcome Measures

Name	Time	Method
Stress response 2 hours ISMA Stress Questionnaire,Monoamine oxidase activities in serum 2 hours Elisa method,The changes of hematological and clinical chemistry parameters 2 hours laboratory,Safety evaluation and side effect 2 hours Questionnaire,Electrocardiogram (EKG) 2 hours Electrocardiograph