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Nattokinase has been confirmed by many experiments to have a thrombolytic effect, but there are currently very few studies on nattokinase's effect on gut microbiota, sleeping status, and age-related cognitive function. Therefore, this study intends to explore the effect of nattokinase on cardiovascular disease risk factors, intestinal microbiota, sleep status and cognitive function in patients with metabolic syndrome risk and sleep disorders. This study will be a double-blind, self-control, placebo, crossover trial, and recruit 70-80 participants over 18 years old, and have risk of metabolic syndrome and sleep disorders. They will be divided into a placebo group and an experimental group. The experimental period was divided into two phases (12 weeks for each) and a 2-week washout period. In the first phase, 2 placebo or nattokinase capsules were given each day (each capsule contained nattokinase 3000FU, 2 capsules per day). After 12 weeks, a 2-week washout period was entered, and the second phase was entered for a crossover trial. At the 0th and 12th weeks of each stage, body position, blood pressure, blood biochemical values, sleep quality questionnaire, and cognitive function questionnaire will be measured, and feces will be collected for bacterial analysis. In addition, to improve the compliance of the trial, it is planned to ask the subjects to return for a follow-up visit in the 6th week of each phase, and to measure the subject's body composition and blood pressure. This study expects that daily supplementation of 2 nattokinase capsules for 12 weeks can improve cardiovascular risk factors, sleep quality and cognitive function, while also maintaining healthy intestinal flora.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: nattokinase | Experimental | Dietary supplement: nattokinase (containing nattokinase 3000FU per capsule) This group will be given supplements for 12 weeks. |
|
| Placebo Comparator: placebo | Placebo Comparator | Placebo treatment (identical capsules containing Microcrystalline Cellulose) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nattokinase | Dietary Supplement | Participants will be divided into a placebo group and an experimental group. The experimental period was divided into two phases (12 weeks for each) and a 2-week washout period. In the first phase, 2 nattokinase capsules were given each day (each capsule contained nattokinase 3000FU, 2 capsules per day). After 12 weeks, a 2-week washout period was entered, and the second phase was entered for a crossover trial. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline The Pittsburgh Sleep Quality Index (PSQI) at 3 months | PSQI is used to evaluate sleeping quality. A self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. | At 0th week, and 12th week for each of the two phases. |
| Change from Baseline Insomnia Severity Scale at 3 months | ISI is a simple self-assessment questionnaire for evaluating the severity of insomnia, assessing the severity of insomnia over the past two weeks in the study participants. | At 0th week, and 12th week for each of the two phases. |
| Change from Baseline Epworth Sleepiness Scale (ESS) at 3 months | ESS is a self-administered questionnaire, and is used to assess the "daytime sleepiness" of the patients. | At 0th week, and 12th week for each of the two phases. |
| Change from Baseline Patient Health Questionnaire at 3 months | PHQ-9 is a widely used tool for assessing depressive symptoms in both clinical and research settings, evaluating the severity of depressive symptoms over the past two weeks through 9 questions. | At 0th week, and 12th week for each of the two phases. |
| Change from Baseline Generalized Anxiety Disorder at 3 months | GAD-7 is a brief self-report scale specifically designed to assess the frequency and severity of anxiety symptoms over the past two weeks. | At 0th week, and 12th week for each of the two phases. |
| Change from Baseline Oguri-Shirakawa-Azumi Sleep Inventory MA version at 3 months | OSA Sleep Inventory MA version is a psychological measurement tool suitable for clinical settings and for middle-aged and elderly individuals who are unable to appropriately respond to multiple-choice questions, used to assess an individual's self-evaluation of sleep upon waking. |
| Measure | Description | Time Frame |
|---|---|---|
| Anthropometric Assessment | body weight (kg) | At 0th week, 6th week, and 12th week for each of the two phases. |
| Anthropometric Assessment | Body fat mass (%/kg) |
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Inclusion Criteria:
Over 18 years old
Meet the criteria of MetS: meet at least two of the following four items will be recognized as at risk of metabolic syndrome:
The Apnea Hypopnea Index (AHI) was diagnosed by overnight multi-channel sleep physiology examination (Polysomnography, PSG) or Home Sleep Apnea Test (HSAT) to be between 5 and 30, indicating mild or moderate sleep apnea.
No major mental illness or obvious symptoms of anxiety or depression
No combination with other primary sleep diseases
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Suh-Ching Yang | Contact | +886-2-2736-1661 Ext. 6553 | sokei@tmu.edu.tw |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Medical University | Recruiting | Taipei | 110 | Taiwan |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D020447 | Parasomnias |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| C053771 | nattokinase |
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|
| Placebo | Other | Participants will be divided into a placebo group and an experimental group. The experimental period was divided into two phases (12 weeks for each) and a 2-week washout period. In the first phase, 2 placebo capsules were given each day (each capsule contained Microcrystalline Cellulose, 2 capsules per day). After 12 weeks, a 2-week washout period was entered, and the second phase was entered for a crossover trial. |
|
| At 0th week, and 12th week for each of the two phases. |
| Change from Baseline The Cambridge Neuropsychological Test Automated Battery at 3 months | CANTAB (Cambridge Neuropsychological Test Automated Battery) is a computerized cognitive function testing system developed by the University of Cambridge, This study will use the preclinical dementia test battery recommended by CANTAB. This test battery has been proven to have better sensitivity and discriminative ability compared to traditional assessment methods including ADAS-cog and MMSE, and can detect cognitive function changes in the short to medium term. The overall assessment includes the following 7 subtests:
| At 0th week, and 12th week for each of the two phases. |
| At 0th week, 6th week, and 12th week for each of the two phases. |
| Anthropometric Assessment | Skeletal muscle mass (%/kg) | At 0th week, 6th week, and 12th week for each of the two phases. |
| Blood pressure | blood pressure (mmHg) | At 0th week, 6th week, and 12th week for each of the two phases. |
| Liver Function | Serum AST (U/L) | At 0th week, and 12th week for each of the two phases. |
| Liver Function | Serum ALT (U/L) | At 0th week, and 12th week for each of the two phases. |
| Kidney Function | Serum BUN (mg/dL) | At 0th week, and 12th week for each of the two phases. |
| Kidney Function | Creatinine (mg/dL) | At 0th week, and 12th week for each of the two phases. |
| Kidney Function | eGFR (mL/min) | At 0th week, and 12th week for each of the two phases. |
| Kidney Function | uric acid (mg/dL) | At 0th week, and 12th week for each of the two phases. |
| Lipid Profile | Serum HDL-C (mg/dL) | At 0th week, and 12th week for each of the two phases. |
| Lipid Profile | Serum LDL-C (mg/dL) | At 0th week, and 12th week for each of the two phases. |
| Lipid Profile | Serum triglyceride (mg/dL) | At 0th week, and 12th week for each of the two phases. |
| Lipid Profile | Serum total cholesterol (mg/dL) | At 0th week, and 12th week for each of the two phases. |
| Hematology | Complete Blood Count | At 0th week, and 12th week for each of the two phases. |
| Antioxidative Status | Concentration of thiobarbituric acid-reactive substance | At 0th week, and 12th week for each of the two phases. |
| Antioxidative Status | Glutathione/oxidized glutathione ratio. | At 0th week, and 12th week for each of the two phases. |
| Fecal Microbiota | Using 16S rRNA and next-generation sequencing to analyze gut microbiota composition. | At 0th week, and 12th week for each of the two phases. |
| D009750 |
| Nutritional and Metabolic Diseases |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |