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

Not Applicable

Completed

• Conditions: Perceived Stress
• Interventions: Dietary Supplement: Fermented rice; Dietary Supplement: placebo

• Registration Number: NCT06091033
• Lead Sponsor: Pusan National University Yangsan Hospital

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.

Study Timeline

• Study Start: 2022-01-03
• Study First Submitted: 2023-10-13
• Study First Submitted QC: 2023-10-18
• Study First Posted: 2023-10-19
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-31
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-07
• Last Update Posted: 2024-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fermented rice group	Fermented rice	This group takes black rice (Oryza Sativa L.) extract fermented with Lactobacillus for 8 weeks.
Control group	placebo	This group takes a placebo for 8 weeks.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Salivary cortisol (ng/dl)	8 weeks	Change during 8 weeks
Plasma serotonin (nmol/L)	8 weeks	Change during 8 weeks
Plasma cortisol/dehydroepiandrosterone sulfate ratio	8 weeks	Change during 8 weeks
Plasma adrenocorticotropic hormone (pg/mL)	8 weeks	Change during 8 weeks
Fasting glucose (mg/dL)	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.
Plasma cortisol (ng/dl)	8 weeks	Change during 8 weeks
Plasma dehydroepiandrosterone sulfate (µg/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
Heart rate (beats per minute)	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

Trial Locations

Locations (1)

Pusan National University Yangsan Hospital; 🇰🇷 Yangsan, Gyeungsangnam-do, Korea, Republic of