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

NCT07229521 | Recruiting

• 1 other identifier: N202412072
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  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.

  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.

  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.

  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: 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)

  At 0th week, and 12th week for each of the two phases.

Secondary Outcomes (18)

• Anthropometric Assessment

  At 0th week, 6th week, and 12th week for each of the two phases.

• Anthropometric Assessment

  At 0th week, 6th week, and 12th week for each of the two phases.

• Anthropometric Assessment

  At 0th week, 6th week, and 12th week for each of the two phases.

• Blood pressure

  At 0th week, 6th week, and 12th week for each of the two phases.

• Liver Function

  At 0th week, and 12th week for each of the two phases.

Study Arms (2)

Experimental: nattokinase

EXPERIMENTAL

Dietary supplement: nattokinase (containing nattokinase 3000FU per capsule) This group will be given supplements for 12 weeks.

Dietary Supplement: Nattokinase

Placebo Comparator: placebo

PLACEBO COMPARATOR

Placebo treatment (identical capsules containing Microcrystalline Cellulose)

Other: Placebo

Interventions

Nattokinase DIETARY_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.

Experimental: nattokinase

Placebo OTHER

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.

Placebo Comparator: placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (1)

Taipei Medical University

Taipei, 110, Taiwan

RECRUITING

MeSH Terms

Conditions

Metabolic Syndrome; Parasomnias

Interventions

nattokinase

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Suh-Ching Yang

CONTACT

+886-2-2736-1661 Ext. 6553; sokei@tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: November 17, 2025
• Study Start: March 15, 2025
• Primary Completion (Estimated): December 11, 2026
• Study Completion (Estimated): February 11, 2027
• Last Updated: November 17, 2025

Record last verified: 2025-02

Locations

TW (1)