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

Pusan National University Yangsan Hospital

Status: Completed

Conditions: Perceived Stress

Treatments: Dietary Supplement: placebo; Dietary Supplement: Fermented rice

Study type: Interventional

Funder types: Other

Identifiers

NCT06091033

IRB 02-2021-041

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 19 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups, including a placebo group

Fermented rice group

Experimental group

Description:

This group takes black rice (Oryza Sativa L.) extract fermented with Lactobacillus for 8 weeks.

Treatment:

Dietary Supplement: Fermented rice

Control group

Placebo Comparator group

Description:

This group takes a placebo for 8 weeks.

Treatment:

Dietary Supplement: placebo