Perceived Stress
Conditions
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.
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.
Interventions
DIETARY_SUPPLEMENTFermented rice
1,000 mg of black rice (Oryza Sativa L.) extract fermented with Lactobacillus for 8 weeks
DIETARY_SUPPLEMENTplacebo
1,000 mg of a placebo for 8 weeks
Sponsors
Pusan National University Yangsan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| stress response inventory (SRI) | 8 weeks | using SRI score. The minimum score was 0, and the maximum score was 195; higher scores mean a worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fasting glucose (mg/dL) | 8 weeks | Change during 8 weeks |
| Lactate (mmol/L) | 8 weeks | Change during 8 weeks |
| Free fatty acid (µmol/L) | 8 weeks | Change during 8 weeks |
| Plasma cortisol (ng/dl) | 8 weeks | Change during 8 weeks |
| Plasma serotonin (nmol/L) | 8 weeks | Change during 8 weeks |
| Plasma dehydroepiandrosterone sulfate (µg/dL) | 8 weeks | Change during 8 weeks |
| Plasma cortisol/dehydroepiandrosterone sulfate ratio | 8 weeks | Change during 8 weeks |
| Heart rate (beats per minute) | 8 weeks | Change during 8 weeks |
| perceived stress scale (PSS) | 8 weeks | using PSS score. The minimum score was 0, and the maximum score was 40; higher scores mean a worse outcome. |
| stress-Visual Analog Scale (VAS) | 8 weeks | using stress-VAS score. The minimum score was 0, and the maximum score was 100; higher scores mean a worse outcome. |
| EuroQol (EQ)-5D-5L | 8 weeks | using stress-VAS score. The minimum score was 0, and the maximum score was 1; higher scores mean a worse outcome. |
| Salivary cortisol (ng/dl) | 8 weeks | Change during 8 weeks |
| Systolic blood pressure (BP) (mmHg) | 8 weeks | Change during 8 weeks |
| Diastolic BP(mmHg) | 8 weeks | Change during 8 weeks |
| Plasma adrenocorticotropic hormone (pg/mL) | 8 weeks | Change during 8 weeks |
Countries
South Korea
Outcome results
None listed