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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Perceived Stress

Intervention / Treatment
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* Dietary Supplement: Fermented rice
* Dietary Supplement: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 |