Perceived Stress and Black Rice (Oryza Sativa L.) Extract Fermented With Lactobacillus: a Double-blind, Randomized, Placebo-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- stress response inventory (SRI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- the Perceived Stress Scale between 13-18
排除标准
- •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.
研究组 & 干预措施
Control group
This group takes a placebo for 8 weeks.
干预措施: placebo (Dietary Supplement)
Fermented rice group
This group takes black rice (Oryza Sativa L.) extract fermented with Lactobacillus for 8 weeks.
干预措施: Fermented rice (Dietary Supplement)
结局指标
主要结局
stress response inventory (SRI)
时间窗: 8 weeks
using SRI score. The minimum score was 0, and the maximum score was 195; higher scores mean a worse outcome.
次要结局
- Salivary cortisol (ng/dl)(8 weeks)
- Plasma serotonin (nmol/L)(8 weeks)
- Plasma cortisol/dehydroepiandrosterone sulfate ratio(8 weeks)
- Plasma adrenocorticotropic hormone (pg/mL)(8 weeks)
- Fasting glucose (mg/dL)(8 weeks)
- perceived stress scale (PSS)(8 weeks)
- stress-Visual Analog Scale (VAS)(8 weeks)
- EuroQol (EQ)-5D-5L(8 weeks)
- Plasma cortisol (ng/dl)(8 weeks)
- Plasma dehydroepiandrosterone sulfate (µg/dL)(8 weeks)
- Lactate (mmol/L)(8 weeks)
- Free fatty acid (µmol/L)(8 weeks)
- Heart rate (beats per minute)(8 weeks)
- Systolic blood pressure (BP) (mmHg)(8 weeks)
- Diastolic BP(mmHg)(8 weeks)
研究者
Sang Yeoup Lee
Professor
Pusan National University Yangsan Hospital