Metabolic SyndromeNCT07229521
Effects of Nattokinase on Cardiovascular Risk, Gut Microbiota, Sleep, and Cognition in Metabolic Syndrome With Sleep Disorders.
A study testing Nattokinase in people with Metabolic Syndrome and Sleeping Disorders, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Syndrome, Sleeping Disorders
- What is being tested?
- Nattokinase
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Mar 2025to 11 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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
- Dyslipidemia: High fasting triglycerides (≧150mg/dL) or low high-density lipoprotein cholesterol (HDL-C) (<40mg/dL for male, <50mg/dL for female)
Show all 9Show fewer
- 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
Who cannot join
- Body mass index (BMI) >30 kg/m^2
- 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
- Pregnancy or breastfeeding
- Person expected to perform the surgery.
- Those who have participated in other clinical trials in the past 28 days.
- May be allergic to the ingredients in the test materials, or take drugs or dietary supplements that may affect the test results
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Medical University
Taipei, 110
Suh-Ching Yang, +886-2-2736-1661 Ext. 6553, sokei@tmu.edu.tw
About this study
Official title: Effects of Nattokinase on Cardiovascular Disease Risk Factors, Gut Microbiota, Sleeping and Cognitive Function in Patients With Risk of Metabolic Syndrome Along With Sleeping Disorder.
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.
- Conditions
- Metabolic Syndrome, Sleeping Disorders
- Being tested
- Nattokinase, Placebo
- Medical subject headings
- Metabolic Syndrome, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NattokinaseDietary 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.
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: nattokinase | Experimental | Dietary supplement: nattokinase (containing nattokinase 3000FU per capsule) This group will be given supplements for 12 weeks. Receives: Dietary Supplement: Nattokinase |
| Placebo Comparator: placebo | Placebo comparator | Placebo treatment (identical capsules containing Microcrystalline Cellulose) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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:
- Motor Screening Task (MOT)
- Reaction Time (RTI)
- Paired Associates Learning (PAL)
- Spatial Working Memory (SWM)
- Pattern Recognition Memory (PRM)
- Delayed Matching to Sample (DMS)
- Rapid Visual Information Processing (RVP)
Measured: At 0th week, and 12th week for each of the two phases.
Secondary outcomes (18)
Anthropometric Assessment
body weight (kg)
Measured: At 0th week, 6th week, and 12th week for each of the two phases.
Anthropometric Assessment
Body fat mass (%/kg)
Measured: At 0th week, 6th week, and 12th week for each of the two phases.
Anthropometric Assessment
Skeletal muscle mass (%/kg)
Measured: At 0th week, 6th week, and 12th week for each of the two phases.
Blood pressure
blood pressure (mmHg)
Measured: At 0th week, 6th week, and 12th week for each of the two phases.
Liver Function
Serum AST (U/L)
Measured: At 0th week, and 12th week for each of the two phases.
Liver Function
Serum ALT (U/L)
Measured: At 0th week, and 12th week for each of the two phases.
Kidney Function
Serum BUN (mg/dL)
Measured: At 0th week, and 12th week for each of the two phases.
Kidney Function
Creatinine (mg/dL)
Measured: At 0th week, and 12th week for each of the two phases.
Kidney Function
eGFR (mL/min)
Measured: At 0th week, and 12th week for each of the two phases.
Kidney Function
uric acid (mg/dL)
Measured: At 0th week, and 12th week for each of the two phases.
Lipid Profile
Serum HDL-C (mg/dL)
Measured: At 0th week, and 12th week for each of the two phases.
Lipid Profile
Serum LDL-C (mg/dL)
Measured: At 0th week, and 12th week for each of the two phases.
Lipid Profile
Serum triglyceride (mg/dL)
Measured: At 0th week, and 12th week for each of the two phases.
Lipid Profile
Serum total cholesterol (mg/dL)
Measured: At 0th week, and 12th week for each of the two phases.
Hematology
Complete Blood Count
Measured: At 0th week, and 12th week for each of the two phases.
Antioxidative Status
Concentration of thiobarbituric acid-reactive substance
Measured: At 0th week, and 12th week for each of the two phases.
Antioxidative Status
Glutathione/oxidized glutathione ratio.
Measured: 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.
Measured: At 0th week, and 12th week for each of the two phases.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start15 Mar 2025
- Primary completion11 Dec 2026 (estimated)
- Study completion11 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07229521
- Sponsor's protocol ID
- N202412072
- Status last verified
- Feb 2025
- First submitted
- 8 Apr 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Nattokinase on Cardiovascular Disease Risk Factors, Gut Microbiota, Sleeping and Cognitive Function in Patients With Risk of Metabolic Syndrome Along With Sleeping Disorder.
- ClinicalTrials.gov ID
- NCT07229521
- Acronym / sponsor ID
- N202412072
- Conditions
- Metabolic Syndrome, Sleeping Disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 15 Mar 2025 (actual)
- Primary completion
- 11 Dec 2026 (estimated)
- Study completion
- 11 Feb 2027 (estimated)
- First posted
- 17 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: nattokinase | Experimental | Dietary Supplement: NattokinaseDietary supplement: nattokinase (containing nattokinase 3000FU per capsule) This group will be given supplements for 12 weeks. |
| Placebo Comparator: placebo | Placebo comparator | Other: PlaceboPlacebo treatment (identical capsules containing Microcrystalline Cellulose) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- Body mass index (BMI) >30 kg/m^2
- 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
- Pregnancy or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NattokinaseParticipants 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. | Dietary supplement | Experimental: nattokinase |
| PlaceboParticipants 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. | Other | Placebo Comparator: placebo |
Primary outcome
Change from Baseline The Pittsburgh Sleep Quality Index (PSQI) at 3 months
Time frame: At 0th week, and 12th week for each of the two phases.
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
Time frame: At 0th week, and 12th week for each of the two phases.
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
Time frame: At 0th week, and 12th week for each of the two phases.
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
Time frame: At 0th week, and 12th week for each of the two phases.
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.
Change from Baseline Generalized Anxiety Disorder at 3 months
Time frame: At 0th week, and 12th week for each of the two phases.
GAD-7 is a brief self-report scale specifically designed to assess the frequency and severity of anxiety symptoms over the past two weeks.
Change from Baseline Oguri-Shirakawa-Azumi Sleep Inventory MA version at 3 months
Time frame: At 0th week, and 12th week for each of the two phases.
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.
Change from Baseline The Cambridge Neuropsychological Test Automated Battery at 3 months
Time frame: At 0th week, and 12th week for each of the two phases.
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: 1. Motor Screening Task (MOT) 2. Reaction Time (RTI) 3. Paired Associates Learning (PAL) 4. Spatial Working Memory (SWM) 5. Pattern Recognition Memory (PRM) 6. Delayed Matching to Sample (DMS) 7. Rapid Visual Information Processing (RVP)
18 secondary outcomes
Anthropometric Assessment
Time frame: At 0th week, 6th week, and 12th week for each of the two phases.
Anthropometric Assessment
Time frame: At 0th week, 6th week, and 12th week for each of the two phases.
Anthropometric Assessment
Time frame: At 0th week, 6th week, and 12th week for each of the two phases.
Blood pressure
Time frame: At 0th week, 6th week, and 12th week for each of the two phases.
Liver Function
Time frame: At 0th week, and 12th week for each of the two phases.
Liver Function
Time frame: At 0th week, and 12th week for each of the two phases.
Kidney Function
Time frame: At 0th week, and 12th week for each of the two phases.
Kidney Function
Time frame: At 0th week, and 12th week for each of the two phases.
Kidney Function
Time frame: At 0th week, and 12th week for each of the two phases.
Kidney Function
Time frame: At 0th week, and 12th week for each of the two phases.
Lipid Profile
Time frame: At 0th week, and 12th week for each of the two phases.
Lipid Profile
Time frame: At 0th week, and 12th week for each of the two phases.
Lipid Profile
Time frame: At 0th week, and 12th week for each of the two phases.
Lipid Profile
Time frame: At 0th week, and 12th week for each of the two phases.
Hematology
Time frame: At 0th week, and 12th week for each of the two phases.
Antioxidative Status
Time frame: At 0th week, and 12th week for each of the two phases.
Antioxidative Status
Time frame: At 0th week, and 12th week for each of the two phases.
Fecal Microbiota
Time frame: At 0th week, and 12th week for each of the two phases.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nattokinase in people with Metabolic Syndrome and Sleeping Disorders, run by Taipei Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Suh-Ching Yang (+886-2-2736-1661 Ext. 6553, sokei@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline The Pittsburgh Sleep Quality Index (PSQI) at 3 months (time frame: At 0th week, and 12th week for each of the two phases.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.