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Completed

NCT Number: NCT06091033

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

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.

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Key information

Conditions

Perceived Stress

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pusan National University Yangsan Hospital

Yangsan, Gyeungsangnam-do, 50612, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

fermented rice

Dietary Supplement

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

Placebo

Dietary Supplement

1,000 mg of a placebo for 8 weeks

Primary outcomes

  1. 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.

Secondary outcomes

  1. perceived stress scale (PSS)

    Time frame: 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)

    Time frame: 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

    Time frame: 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)

    Time frame: 8 weeks

    Change during 8 weeks

  5. Plasma cortisol (ng/dl)

    Time frame: 8 weeks

    Change during 8 weeks

  6. Plasma serotonin (nmol/L)

    Time frame: 8 weeks

    Change during 8 weeks

  7. Plasma dehydroepiandrosterone sulfate (µg/dL)

    Time frame: 8 weeks

    Change during 8 weeks

  8. Plasma cortisol/dehydroepiandrosterone sulfate ratio

    Time frame: 8 weeks

    Change during 8 weeks

  9. Plasma adrenocorticotropic hormone (pg/mL)

    Time frame: 8 weeks

    Change during 8 weeks

  10. Fasting glucose (mg/dL)

    Time frame: 8 weeks

    Change during 8 weeks

  11. Lactate (mmol/L)

    Time frame: 8 weeks

    Change during 8 weeks

  12. Free fatty acid (µmol/L)

    Time frame: 8 weeks

    Change during 8 weeks

  13. Heart rate (beats per minute)

    Time frame: 8 weeks

    Change during 8 weeks

  14. Systolic blood pressure (BP) (mmHg)

    Time frame: 8 weeks

    Change during 8 weeks

  15. Diastolic BP(mmHg)

    Time frame: 8 weeks

    Change during 8 weeks

Sponsors and collaborators

Lead sponsor

Pusan National University Yangsan Hospital

Other

Registry information

Official study title

Perceived Stress and Black Rice (Oryza Sativa L.) Extract Fermented With Lactobacillus: a Double-blind, Randomized, Placebo-controlled Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 19, 2023
Registry last updated
Apr 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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