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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fermented rice group | Experimental | This group takes black rice (Oryza Sativa L.) extract fermented with Lactobacillus for 8 weeks. |
|
| Control group | Placebo Comparator | This group takes a placebo for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fermented rice | Dietary Supplement | 1,000 mg of black rice (Oryza Sativa L.) extract fermented with Lactobacillus for 8 weeks |
|
| 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 |
| 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. |
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Inclusion Criteria:
- the Perceived Stress Scale between 13-18
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sang Yeoup Lee, MD, PhD | Pusan National University Yangsan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pusan National University Yangsan Hospital | Yangsan | Gyeungsangnam-do | 50612 | South Korea |
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| placebo | Dietary Supplement | 1,000 mg of a placebo for 8 weeks |
|
| 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 |