Perceived StressNCT06091033
Perceived Stress and Black Rice (Oryza Sativa L.) Extract Fermented With Lactobacillus
A study testing Fermented rice in people with Perceived Stress, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Perceived Stress
- What is being tested?
- Fermented rice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Jan 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- the Perceived Stress Scale between 13-18
Who cannot join
- 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 locations and contacts
1 site in 1 country.
South Korea1 site
Pusan National University Yangsan Hospital
Yangsan, Gyeungsangnam-do, 50612
About this study
Official title: Perceived Stress and Black Rice (Oryza Sativa L.) Extract Fermented With Lactobacillus: a Double-blind, Randomized, Placebo-controlled Study
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.
- Conditions
- Perceived Stress
- Being tested
- Fermented rice, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fermented riceDietary supplement
1,000 mg of black rice (Oryza Sativa L.) extract fermented with Lactobacillus for 8 weeks
placeboDietary supplement
1,000 mg of a placebo for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Fermented rice group | Experimental | This group takes black rice (Oryza Sativa L.) extract fermented with Lactobacillus for 8 weeks. Receives: Dietary Supplement: Fermented rice |
| Control group | Placebo comparator | This group takes a placebo for 8 weeks. Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
stress response inventory (SRI)
using SRI score. The minimum score was 0, and the maximum score was 195; higher scores mean a worse outcome.
Measured: 8 weeks
Secondary outcomes (15)
perceived stress scale (PSS)
using PSS score. The minimum score was 0, and the maximum score was 40; higher scores mean a worse outcome.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
Salivary cortisol (ng/dl)
Change during 8 weeks
Measured: 8 weeks
Plasma cortisol (ng/dl)
Change during 8 weeks
Measured: 8 weeks
Plasma serotonin (nmol/L)
Change during 8 weeks
Measured: 8 weeks
Plasma dehydroepiandrosterone sulfate (µg/dL)
Change during 8 weeks
Measured: 8 weeks
Plasma cortisol/dehydroepiandrosterone sulfate ratio
Change during 8 weeks
Measured: 8 weeks
Plasma adrenocorticotropic hormone (pg/mL)
Change during 8 weeks
Measured: 8 weeks
Fasting glucose (mg/dL)
Change during 8 weeks
Measured: 8 weeks
Lactate (mmol/L)
Change during 8 weeks
Measured: 8 weeks
Free fatty acid (µmol/L)
Change during 8 weeks
Measured: 8 weeks
Heart rate (beats per minute)
Change during 8 weeks
Measured: 8 weeks
Systolic blood pressure (BP) (mmHg)
Change during 8 weeks
Measured: 8 weeks
Diastolic BP(mmHg)
Change during 8 weeks
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start3 Jan 2022
- Primary completion30 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perceived StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang Yeoup Lee, Pusan National University Yangsan Hospital
- Investigators
- Sang Yeoup Lee, MD, PhD, Principal investigator, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06091033
- Sponsor's protocol ID
- IRB 02-2021-041
- Status last verified
- Apr 2024
- First submitted
- 13 Oct 2023
- Last updated
- 9 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perceived Stress and Black Rice (Oryza Sativa L.) Extract Fermented With Lactobacillus: a Double-blind, Randomized, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT06091033
- Acronym / sponsor ID
- IRB 02-2021-041
- Conditions
- Perceived Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- 3 Jan 2022 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 19 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fermented rice group | Experimental | Dietary Supplement: Fermented riceThis group takes black rice (Oryza Sativa L.) extract fermented with Lactobacillus for 8 weeks. |
| Control group | Placebo comparator | Dietary Supplement: placeboThis group takes a placebo for 8 weeks. |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- the Perceived Stress Scale between 13-18
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fermented rice1,000 mg of black rice (Oryza Sativa L.) extract fermented with Lactobacillus for 8 weeks | Dietary supplement | Fermented rice group |
| placebo1,000 mg of a placebo for 8 weeks | Dietary supplement | Control group |
Primary outcome
stress response inventory (SRI)
Time frame: 8 weeks
using SRI score. The minimum score was 0, and the maximum score was 195; higher scores mean a worse outcome.
15 secondary outcomes
perceived stress scale (PSS)
Time frame: 8 weeks
stress-Visual Analog Scale (VAS)
Time frame: 8 weeks
EuroQol (EQ)-5D-5L
Time frame: 8 weeks
Salivary cortisol (ng/dl)
Time frame: 8 weeks
Plasma cortisol (ng/dl)
Time frame: 8 weeks
Plasma serotonin (nmol/L)
Time frame: 8 weeks
Plasma dehydroepiandrosterone sulfate (µg/dL)
Time frame: 8 weeks
Plasma cortisol/dehydroepiandrosterone sulfate ratio
Time frame: 8 weeks
Plasma adrenocorticotropic hormone (pg/mL)
Time frame: 8 weeks
Fasting glucose (mg/dL)
Time frame: 8 weeks
Lactate (mmol/L)
Time frame: 8 weeks
Free fatty acid (µmol/L)
Time frame: 8 weeks
Heart rate (beats per minute)
Time frame: 8 weeks
Systolic blood pressure (BP) (mmHg)
Time frame: 8 weeks
Diastolic BP(mmHg)
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sang Yeoup Lee, MD, PhD principal investigator
Pusan National University Yangsan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fermented rice in people with Perceived Stress, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stress response inventory (SRI) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2024.