Nattokinase for cardiovascular risk, gut bacteria, sleep, and thinking in people with metabolic syndrome and sleep apnea

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled crossover trial enrolling 70–80 adults at risk for metabolic syndrome who have mild-to-moderate sleep apnea (AHI 5–30). Participants will take either nattokinase (two capsules daily, 3000 FU per capsule) or matching placebo for 12 weeks, undergo a 2-week washout, then cross over to the other arm for a second 12-week period. Investigators will collect clinical and laboratory measures of cardiovascular risk, stool samples to analyze gut microbiota, sleep measures (PSG or HSAT and sleep questionnaires), and brief cognitive tests before and after each treatment period. The crossover, within-subject design aims to reduce variability and compare each participant’s response to nattokinase versus placebo.

Why it matters

Who can join: the full rules

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

Where it's running

• Taipei Medical University
  Taipei, Taiwan Recruiting

Study contacts

• Study coordinator: Suh-Ching Yang
• Email: sokei@tmu.edu.tw
• Phone: +886-2-2736-1661 Ext. 6553

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.