Clinical trial NCT06091033: Perceived Stress and Black Rice (Oryza Sativa L.) Extract Fermented With Lactobacillus
Official title: Perceived Stress and Black Rice (Oryza Sativa L.) Extract Fermented With Lactobacillus: a Double-blind, Randomized, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perceived Stress
Lead sponsor: Pusan National University Yangsan Hospital
Sponsor class: OTHER
First posted: 2023-10-19
Enrollment: 80
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: stress response inventory (SRI)
timeFrame: 8 weeks
Secondary outcomes:
measure: perceived stress scale (PSS)
timeFrame: 8 weeks
measure: stress-Visual Analog Scale (VAS)
timeFrame: 8 weeks
measure: EuroQol (EQ)-5D-5L
timeFrame: 8 weeks
measure: Salivary cortisol (ng/dl)
timeFrame: 8 weeks
measure: Plasma cortisol (ng/dl)
timeFrame: 8 weeks
measure: Plasma serotonin (nmol/L)
timeFrame: 8 weeks
measure: Plasma dehydroepiandrosterone sulfate (µg/dL)
timeFrame: 8 weeks
measure: Plasma cortisol/dehydroepiandrosterone sulfate ratio
timeFrame: 8 weeks
measure: Plasma adrenocorticotropic hormone (pg/mL)
timeFrame: 8 weeks
measure: Fasting glucose (mg/dL)
timeFrame: 8 weeks
measure: Lactate (mmol/L)
timeFrame: 8 weeks
measure: Free fatty acid (µmol/L)
timeFrame: 8 weeks
measure: Heart rate (beats per minute)
timeFrame: 8 weeks
measure: Systolic blood pressure (BP) (mmHg)
timeFrame: 8 weeks
measure: Diastolic BP(mmHg)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
state: Gyeungsangnam-do
Study officials:
affiliation: Pusan National University Yangsan Hospital
name: Sang Yeoup Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: