Effect of Mulberry Capsule on Stress Index in Working Age Volunteers

Phase 1

Completed

• Conditions: Healthy conditions; Mulberry fruits; Brain Supplement; Stress Index; Cognitive function; Working age

• Registration Number: TCTR20201005004
• Lead Sponsor: Food Innopolis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-05
• Study Completion: 2021-11-18
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

1.Aged between 20-55 years old
2.Body Mass Index (BMI) between 18.5-25 kg/m2
3.Depression Anxiety Stress Scales(DASS-21)score between 10-12

Exclusion Criteria

1.Volunteers who have serious physical illness such as cardiovascular diseases, respiratory diseases, neuropsychological diseases, head injury, diabetes mellitus, liver disease, cancer, autoimmune diseases and psychological disorder
2.Volunteers who use antibiotics within 1 week before participating in this study (except hydroxychloroquine)
3.Volunteers who use probiotics within 3 months before participating in this study
4.Volunteers who have been Hysterectomy and/or Oophorectomy
5.Volunteers who require supplements or any drug that effect on hypothalamic pituitary gonadal axis, hypothalamic pituitary adrenal, hypothalamic pituitary thyroid axis and nervous system by order of the doctor during trial
6.Volunteers who have a regular exercise more than 3 times/week
7.Smoking more than 10 pieces/day
8.Alcohol addiction
9.Volunteers who participate in other projects.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Salivary cortisol 12 weeks Elisa method

Secondary Outcome Measures

Name	Time	Method
Salivary alpha amylase 12 weeks Elisa method, N100 and P300 12 weeks Event related potential (ERPs),Computerized batteries test (CDR) 12 weeks computer,Electrocardiogram (EKG) 12 weeks electrocardiograph,The changes of hematological and clinical chemistry parameters 12 weeks laboratory,Acetylcholinesterase and monoamine oxidase activities in serum 12 weeks Elisa method,Stress evaluation using stress questionnaire 12 weeks DASS-21 and PSS Questionnaire,Safety evaluation and side effect 12 weeks Questionnaire