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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-03

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Psychophysiological Effects of Probiotic Supplementation

NCT05226520

Mild to Moderate Levels of Stress

COMPLETED NA

Exploring the Effects of Lactobacillus Paracasei PS23 on Workplace-related Stress Symptoms Among Office Workers

NCT05826704

Stress

TERMINATED NA

Effect of Probiotics on Lipid Management

NCT03952169

Primary Hypercholesterolemia

UNKNOWN NA

A Pilot Study To Evaluate the Effects of Lactobacillus Supplements

NCT05520073

Feasibility Studies

COMPLETED NA

Effect of 4-week Oral Administration of a Fermented Dairy Product Containing Lactobacillus Rhamnosus CNCM I-3690, on Subjective State Anxiety Levels in Healthy Women Undergoing Academic Stress.

NCT04780763

Anxious Healthy Subjects

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Perceived Stress

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Fermented rice group

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

Group Type EXPERIMENTAL

Fermented rice

Intervention Type DIETARY_SUPPLEMENT

1,000 mg of black rice (Oryza Sativa L.) extract fermented with Lactobacillus for 8 weeks

Control group

This group takes a placebo for 8 weeks.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

1,000 mg of a placebo for 8 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fermented rice

1,000 mg of black rice (Oryza Sativa L.) extract fermented with Lactobacillus for 8 weeks

Intervention Type DIETARY_SUPPLEMENT

placebo

1,000 mg of a placebo for 8 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes