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CompletedNCT06091033Updated Apr 9, 2024

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

An interventional study of Fermented rice and placebo in Perceived Stress, sponsored by Pusan National University Yangsan Hospital. Completed at 1 site in South Korea. Open to participants aged 19 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-09.

Sponsored by Pusan National University Yangsan Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 9 months after the study started (first participant enrolled Jan 2022, registered Oct 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
19 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Perceived Stress
03

In context

Lead sponsor

Pusan National University Yangsan Hospital is the lead sponsor of 108 studies on the registry; 27 are open to participants now.

Browse Pusan National University Yangsan Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

- the Perceived Stress Scale between 13-18

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    Fermented rice group

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

    Dietary Supplement: Fermented rice

  • Placebo comparator
    Control group

    This group takes a placebo for 8 weeks.

    Dietary Supplement: placebo

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

06

What researchers measure

Primary outcomes

  1. stress response inventory (SRI)

    using SRI score. The minimum score was 0, and the maximum score was 195; higher scores mean a worse outcome.

    Time frame: 8 weeks

Secondary outcomes

  1. perceived stress scale (PSS)

    using PSS score. The minimum score was 0, and the maximum score was 40; higher scores mean a worse outcome.

    Time frame: 8 weeks

  2. 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.

    Time frame: 8 weeks

  3. 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.

    Time frame: 8 weeks

  4. Salivary cortisol (ng/dl)

    Change during 8 weeks

    Time frame: 8 weeks

  5. Plasma cortisol (ng/dl)

    Change during 8 weeks

    Time frame: 8 weeks

  6. Plasma serotonin (nmol/L)

    Change during 8 weeks

    Time frame: 8 weeks

  7. Plasma dehydroepiandrosterone sulfate (µg/dL)

    Change during 8 weeks

    Time frame: 8 weeks

  8. Plasma cortisol/dehydroepiandrosterone sulfate ratio

    Change during 8 weeks

    Time frame: 8 weeks

  9. Plasma adrenocorticotropic hormone (pg/mL)

    Change during 8 weeks

    Time frame: 8 weeks

  10. Fasting glucose (mg/dL)

    Change during 8 weeks

    Time frame: 8 weeks

  11. Lactate (mmol/L)

    Change during 8 weeks

    Time frame: 8 weeks

  12. Free fatty acid (µmol/L)

    Change during 8 weeks

    Time frame: 8 weeks

  13. Heart rate (beats per minute)

    Change during 8 weeks

    Time frame: 8 weeks

  14. Systolic blood pressure (BP) (mmHg)

    Change during 8 weeks

    Time frame: 8 weeks

  15. Diastolic BP(mmHg)

    Change during 8 weeks

    Time frame: 8 weeks

07

Study locations

1 site
  • Pusan National University Yangsan Hospital
    Yangsan, Gyeungsangnam-do 50612, South Korea
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2022 to primary completion in Dec 2023, 23 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 13, 2023
First posted
Oct 19, 2023
StartActual
Jan 3, 2022
Primary completionActual
Dec 30, 2023
CompletionActual
Dec 31, 2023
Last update
Apr 9, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06091033
Lead sponsor
Pusan National University Yangsan Hospital
Responsible party
Sang Yeoup Lee (Professor, Pusan National University Yangsan Hospital) — Principal investigator
First posted
Oct 19, 2023
Start date
Jan 3, 2022
Primary completion
Dec 30, 2023
Completion
Dec 31, 2023
Last update
Apr 9, 2024

Study contacts

Sang Yeoup Lee, MD, PhD
principal investigator · Pusan National University Yangsan Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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