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

Pusan National University Yangsan Hospital80 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Perceived Stress

Interventions

Fermented riceDIETARY_SUPPLEMENT

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

placeboDIETARY_SUPPLEMENT

1,000 mg of a placebo for 8 weeks

Eligibility

Sex: ALLMin age: 19 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Pusan National University Yangsan Hospital

Yangsan, Gyeungsangnam-do, South Korea

Outcomes

Primary Outcomes

stress response inventory (SRI)

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

Time frame: 8 weeks

Secondary Outcomes

perceived stress scale (PSS)

using PSS score. The minimum score was 0, and the maximum score was 40; higher scores mean a worse outcome.

Time frame: 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.

Time frame: 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.

Time frame: 8 weeks

Salivary cortisol (ng/dl)

Change during 8 weeks

Time frame: 8 weeks

Plasma cortisol (ng/dl)

Change during 8 weeks

Time frame: 8 weeks

Plasma serotonin (nmol/L)

Change during 8 weeks

Time frame: 8 weeks

Plasma dehydroepiandrosterone sulfate (µg/dL)

Change during 8 weeks

Time frame: 8 weeks

Plasma cortisol/dehydroepiandrosterone sulfate ratio

Data from ClinicalTrials.gov

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