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

NCT ID: NCT07229521

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-15
• Study Completion Date: 2027-02-11

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Experimental: nattokinase

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

Group Type: EXPERIMENTAL

Nattokinase

Intervention Type: 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.

Placebo Comparator: placebo

Placebo treatment (identical capsules containing Microcrystalline Cellulose)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

Nattokinase

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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Taipei Medical University

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Suh-Ching Yang

Role: CONTACT

sokei@tmu.edu.tw

+886-2-2736-1661 Ext. 6553

Facility Contacts

Suh-Ching Yang

Role: primary

sokei@tmu.edu.tw

+886-2-2736-1661 Ext. 6553

Other Identifiers

N202412072

Identifier Type: -

Identifier Source: org_study_id