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

Perceived Stress and Black Rice (Oryza Sativa L.) Extract Fermented With Lactobacillus: a Double-blind, Randomized, Placebo-controlled Study

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.

Study Overview

• Status: Completed
• Conditions: Perceived Stress
• Intervention / Treatment: Dietary supplement: Fermented rice; Dietary supplement: placebo

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 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; the safety of the compound is also evaluated. The Investigators examine stress response inventory (SRI), perceived stress scale (PSS), stress-visual analog scale (VAS), EQ-5D-5L, salivary cortisol, plasma cortisol, serotonin, dehydroepiandrosterone sulfate (DHEAS), cortisol/DHEAS ratio, adrenocorticotropic hormone (ACTH), glucose, lactate, free fatty acid (FFA), malondialdehyde (MDA) superoxide dismutase (SOD), heart rate, systolic blood pressure (BP), and diastolic BP at baseline and after 8 weeks of intervention. Eighty adults were administered either 1,000 mg of black rice (Oryza Sativa L.) extract fermented with Lactobacillus or a placebo each day for 8 weeks.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeungsangnam-do
    • Yangsan, Gyeungsangnam-do, Korea, Republic of, 50612
      • Pusan National University Yangsan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

- the Perceived Stress Scale between 13-18

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group; This group takes a placebo for 8 weeks.	Dietary supplement: placebo; 1,000 mg of a placebo for 8 weeks
Experimental: Fermented rice group; This group takes black rice (Oryza Sativa L.) extract fermented with Lactobacillus for 8 weeks.	Dietary supplement: Fermented rice; 1,000 mg of black rice (Oryza Sativa L.) extract fermented with Lactobacillus for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
perceived stress scale (PSS)	using PSS score. The minimum score was 0, and the maximum score was 40; higher scores mean a worse outcome.	8 weeks
stress-Visual Analog Scale (VAS)	using stress-VAS score. The minimum score was 0, and the maximum score was 100; higher scores mean a worse outcome.	8 weeks
EuroQol (EQ)-5D-5L	using stress-VAS score. The minimum score was 0, and the maximum score was 1; higher scores mean a worse outcome.	8 weeks
Salivary cortisol (ng/dl)	Change during 8 weeks	8 weeks
Plasma cortisol (ng/dl)	Change during 8 weeks	8 weeks
Plasma serotonin (nmol/L)	Change during 8 weeks	8 weeks
Plasma dehydroepiandrosterone sulfate (µg/dL)	Change during 8 weeks	8 weeks
Plasma cortisol/dehydroepiandrosterone sulfate ratio	Change during 8 weeks	8 weeks
Plasma adrenocorticotropic hormone (pg/mL)	Change during 8 weeks	8 weeks
Fasting glucose (mg/dL)	Change during 8 weeks	8 weeks
Lactate (mmol/L)	Change during 8 weeks	8 weeks
Free fatty acid (µmol/L)	Change during 8 weeks	8 weeks
Heart rate (beats per minute)	Change during 8 weeks	8 weeks
Systolic blood pressure (BP) (mmHg)	Change during 8 weeks	8 weeks
Diastolic BP(mmHg)	Change during 8 weeks	8 weeks

Collaborators and Investigators

• Sponsor: Pusan National University Yangsan Hospital
• Investigators: Principal Investigator: Sang Yeoup Lee, MD, PhD, Pusan National University Yangsan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2022
• Primary Completion (Actual): December 30, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: October 13, 2023
• First Submitted That Met QC Criteria: October 18, 2023
• First Posted (Actual): October 19, 2023

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 7, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: IRB 02-2021-041

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No