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.
Over 18 years old
Abdominal obesity: Male≧90cm (35 inches); Female≧80cm (31inches)
High blood pressure: Systolic blood pressure≧120mmHg or diastolic blood pressure≧80mmHg
High fasting blood glucose: Fasting blood glucose≧100mg/dL
Body mass index (BMI) >30 kg/m²
Chronic diseases: abnormal liver and kidney function, abnormal gastrointestinal function, cardiovascular disease, high blood pressure, diabetes mellitus, and hyperlipidemia, etc.
Participants requiring medication for conditions not specified in exclusion criterion (2), who are unable to maintain a stable treatment regimen throughout the trial
Malignant tumors
Crossover
Nattokinase
Dietary supplementParticipants 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.
Placebo
Other interventionParticipants 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.
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.
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.
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.
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.
Anthropometric Assessment
body weight (kg)
Anthropometric Assessment
Body fat mass (%/kg)
Anthropometric Assessment
Skeletal muscle mass (%/kg)
Blood pressure
blood pressure (mmHg)
Click on the lead sponsor to view all of their trials.
