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

• Sponsor: Pusan National University Yangsan Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06091033
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 23.9
• Patients Per Site Per Month: 3.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Perceived Stress	Dietary Supplement: Fermented rice; Dietary Supplement: placebo	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Perceived Stress and Black Rice (Oryza Sativa L.) Extract Fermented With Lactobacillus: a Double-blind, Randomized, Placebo-controlled Study
• Actual Study Start Date: Jan 3, 2022
• Anticipated Primary Completion Date: Dec 30, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fermented rice group This group takes black rice (Oryza Sativa L.) extract fermented with Lactobacillus for 8 weeks.	Dietary Supplement: Fermented rice; 1,000 mg of black rice (Oryza Sativa L.) extract fermented with Lactobacillus for 8 weeks
Placebo Comparator: Control group This group takes a placebo for 8 weeks.	Dietary Supplement: placebo; 1,000 mg of a placebo for 8 weeks

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

3. 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.

4. Salivary cortisol (ng/dl) [8 weeks]

   Change during 8 weeks

5. Plasma cortisol (ng/dl) [8 weeks]

   Change during 8 weeks

6. Plasma serotonin (nmol/L) [8 weeks]

   Change during 8 weeks

7. Plasma dehydroepiandrosterone sulfate (µg/dL) [8 weeks]

   Change during 8 weeks

8. Plasma cortisol/dehydroepiandrosterone sulfate ratio [8 weeks]

   Change during 8 weeks

9. Plasma adrenocorticotropic hormone (pg/mL) [8 weeks]

   Change during 8 weeks

10. Fasting glucose (mg/dL) [8 weeks]

    Change during 8 weeks

11. Lactate (mmol/L) [8 weeks]

    Change during 8 weeks

12. Free fatty acid (µmol/L) [8 weeks]

    Change during 8 weeks

13. Heart rate (beats per minute) [8 weeks]

    Change during 8 weeks

14. Systolic blood pressure (BP) (mmHg) [8 weeks]

    Change during 8 weeks

15. Diastolic BP(mmHg) [8 weeks]

    Change during 8 weeks

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pusan National University Yangsan Hospital	Yangsan	Gyeungsangnam-do	Korea, Republic of	50612

Sponsors and Collaborators

• Pusan National University Yangsan Hospital

Investigators

• Principal Investigator: Sang Yeoup Lee, MD, PhD, Pusan National University Yangsan Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sang Yeoup Lee, Professor, Pusan National University Yangsan Hospital
• ClinicalTrials.gov Identifier: NCT06091033
• Other Study ID Numbers: IRB 02-2021-041
• First Posted: Oct 19, 2023
• Last Update Posted: Oct 19, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Oct 19, 2023