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

Perceived Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06091033
• Other study ID #: IRB 02-2021-041
• Status: Completed
• Phase: N/A
• Start date: January 3, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2024
• Source: Pusan National University Yangsan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 31, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Perceived Stress

Intervention

Dietary Supplement:
• Fermented rice
1,000 mg of black rice (Oryza Sativa L.) extract fermented with Lactobacillus for 8 weeks
• placebo
1,000 mg of a placebo for 8 weeks

Locations

Country	Name	City	State
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan	Gyeungsangnam-do

Sponsors (1)

Lead Sponsor	Collaborator
Pusan National University Yangsan Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Salivary cortisol (ng/dl)	Change during 8 weeks	8 weeks
Secondary	Plasma cortisol (ng/dl)	Change during 8 weeks	8 weeks
Secondary	Plasma serotonin (nmol/L)	Change during 8 weeks	8 weeks
Secondary	Plasma dehydroepiandrosterone sulfate (µg/dL)	Change during 8 weeks	8 weeks
Secondary	Plasma cortisol/dehydroepiandrosterone sulfate ratio	Change during 8 weeks	8 weeks
Secondary	Plasma adrenocorticotropic hormone (pg/mL)	Change during 8 weeks	8 weeks
Secondary	Fasting glucose (mg/dL)	Change during 8 weeks	8 weeks
Secondary	Lactate (mmol/L)	Change during 8 weeks	8 weeks
Secondary	Free fatty acid (µmol/L)	Change during 8 weeks	8 weeks
Secondary	Heart rate (beats per minute)	Change during 8 weeks	8 weeks
Secondary	Systolic blood pressure (BP) (mmHg)	Change during 8 weeks	8 weeks
Secondary	Diastolic BP(mmHg)	Change during 8 weeks	8 weeks