Status:

COMPLETED

Perceived Stress and Black Rice (Oryza Sativa L.) Extract Fermented With Lactobacillus

Lead Sponsor:

Pusan National University Yangsan Hospital

Conditions:

Perceived Stress

Eligibility:

All Genders

19-75 years

Phase:

NA

Brief Summary

The investigators will conduct a randomized, double-blind, placebo-controlled study to investigate the effects and tolerability of black rice (Oryza Sativa L.) extract fermented with Lactobacillus on ...

Detailed Description

A previous animal study has indicated that black rice (Oryza Sativa L.) extract fermented with Lactobacillus relieved stressful situations in a 7-week-old C57BL/6 mice model. Therefore, the investigat...

Eligibility Criteria

Inclusion

  • \- the Perceived Stress Scale between 13-18

Exclusion

  • People with alcohol use/induced disorders
  • Persons with brain disease or undergoing rehabilitation treatment for brain disease
  • Patients with mental illnesses such as major affective disorder, post-traumatic stress disorder, uncontrolled obsessive-compulsive disorder, schizophrenia, dementia, drug addiction, etc.
  • Those who have taken psychotropic drugs, sleeping pills, appetite suppressants, oral steroids, and corticosteroids within 1 month before starting the trial
  • Those who have taken functional health foods recognized by the Ministry of Food and Drug Safety related to relieving tension caused by stress and improving sleep within 1 month before the start of the test
  • Those who show withdrawal symptoms due to abstinence from drinking or smoking within 1 month before starting the trial.

Key Trial Info

Start Date :

January 3 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 31 2023

Estimated Enrollment :

80 Patients enrolled

Trial Details

Trial ID

NCT06091033

Start Date

January 3 2022

End Date

December 31 2023

Last Update

April 9 2024

Active Locations (1)

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Pusan National University Yangsan Hospital

Yangsan, Gyeungsangnam-do, South Korea, 50612