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

NCT06091033 | Completed

• 1 other identifier: IRB 02-2021-041
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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 patients with perceived stress for 8 weeks.

Conditions

Perceived Stress

Outcome Measures

Primary Outcomes (1)

• stress response inventory (SRI)

  using SRI score. The minimum score was 0, and the maximum score was 195; higher scores mean a worse outcome.

  8 weeks

Secondary Outcomes (15)

• perceived stress scale (PSS)

  8 weeks

• stress-Visual Analog Scale (VAS)

  8 weeks

• EuroQol (EQ)-5D-5L

  8 weeks

• Salivary cortisol (ng/dl)

  8 weeks

• Plasma cortisol (ng/dl)

  8 weeks

Study Arms (2)

Fermented rice group

EXPERIMENTAL

This group takes black rice (Oryza Sativa L.) extract fermented with Lactobacillus for 8 weeks.

Dietary Supplement: Fermented rice

Control group

PLACEBO COMPARATOR

This group takes a placebo for 8 weeks.

Dietary Supplement: placebo

Interventions

Fermented rice DIETARY_SUPPLEMENT

1,000 mg of black rice (Oryza Sativa L.) extract fermented with Lactobacillus for 8 weeks

Fermented rice group

placebo DIETARY_SUPPLEMENT

1,000 mg of a placebo for 8 weeks

Control group

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- the Perceived Stress Scale between 13-18

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pusan National University Yangsan Hospital: lead

Study Sites (1)

Pusan National University Yangsan Hospital

Yangsan, Gyeungsangnam-do, 50612, South Korea

Location

Study Officials

• Sang Yeoup Lee, MD, PhD

  Pusan National University Yangsan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: October 19, 2023
• Study Start: January 3, 2022
• Primary Completion: December 30, 2023
• Study Completion: December 31, 2023
• Last Updated: April 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)