Nattokinase: a natural sleep and heart booster?

NCT ID NCT07229521

Symptom relief Sponsor: Taipei Medical University Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether taking nattokinase, a supplement made from fermented soybeans, can improve sleep quality, thinking skills, and heart health in people at risk for metabolic syndrome. About 80 adults will take either the supplement or a placebo for 12 weeks, then switch after a break. Researchers will measure sleep, mood, memory, and blood markers to see if the supplement helps.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: nattokinase (a dietary supplement from fermented soybeans)
What this could lead to: If it works, this could point toward a simple supplement to improve sleep, thinking, and heart health in people with metabolic syndrome risk.
What could go wrong: This is a small, early-stage crossover trial with only 80 participants. Results may not apply to everyone, and the supplement may not work better than a placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

abdominal obesity-metabolic syndrome metabolic syndrome X Parasomnias sleep apnea syndrome sleep disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metabolic syndrome Sleeping disorders

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Nattokinase: a natural sleep and heart booster?

What the study statuses mean