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Effects of Nattokinase on Cardiovascular Risk, Gut Microbiota, Sleep, and Cognition in Metabolic Syndrome With Sleep Disorders.

RecruitingNAAges 18 Years - anyAllTaipei Medical University
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In plain words

What the trial is, and whether it could suit you

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 nat

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Over 18 years old 2. Meet the criteria of MetS: meet at least two of the following four items will be recognized as at risk of metabolic syndrome: 1. Abdominal obesity: Male≧90cm (35 inches); Female≧80cm (31inches) 2. High blood pressure: Systolic blood pressure≧120mmHg or diastolic blood pressure≧80mmHg 3. High fasting blood glucose: Fasting blood glucose≧100mg/dL 4. Dyslipidemia: High fasting triglycerides (≧150mg/dL) or low high-density lipoprotein cholesterol (HDL-C) (\<40mg/dL for male, \<50mg/dL for female) 3. 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. 4. No major mental illness or obvious symptoms of anxiety or depression 5. No combination with other primary sleep diseases Exclusion Criteria: 1. Body mass index (BMI) \>30 kg/m\^2 2. Chronic diseases: abnormal liver and kidney function, abnormal gastrointestinal function, cardiovascular disease, high blood pressure, diabetes mellitus, and hyperlipidemia, etc. 3. Participants requiring medication for conditions not specified in exclusion criterion (2), who are unable to maintain a stable treatment regimen throughout the trial 4. Malignant tumors 5. Pregnancy or breastfeeding 6. Person expected to perform the surgery. 7. Those who have participated in other clinical trials in the past 28 days. 8. May be allergic to the ingredients in the test materials, or take drugs or dietary supplements that may affect the test results
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What it tests

  • Nattokinase
  • Placebo
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Where

1 site
Taipei Medical University
Taipei, Taiwan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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