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

Official title

Effects of Nattokinase on Cardiovascular Disease Risk Factors, Gut Microbiota, Sleeping and Cognitive Function in Patients With Risk of Metabolic Syndrome Along With Sleeping Disorder.

Overview

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.

Interventions

• Dietary supplement 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.
• Other 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.

Primary outcome measures

• Change from Baseline The Pittsburgh Sleep Quality Index (PSQI) at 3 months [Time frame: At 0th week, and 12th week for each of the two phases.]
• Change from Baseline Insomnia Severity Scale at 3 months [Time frame: At 0th week, and 12th week for each of the two phases.]
• Change from Baseline Epworth Sleepiness Scale (ESS) at 3 months [Time frame: At 0th week, and 12th week for each of the two phases.]
• Change from Baseline Patient Health Questionnaire at 3 months [Time frame: At 0th week, and 12th week for each of the two phases.]
• Change from Baseline Generalized Anxiety Disorder at 3 months [Time frame: 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 [Time frame: At 0th week, and 12th week for each of the two phases.]
• Change from Baseline The Cambridge Neuropsychological Test Automated Battery at 3 months [Time frame: At 0th week, and 12th week for each of the two phases.]

Secondary outcome measures (12)

• Anthropometric Assessment [Time frame: At 0th week, 6th week, and 12th week for each of the two phases.]
• Anthropometric Assessment [Time frame: At 0th week, 6th week, and 12th week for each of the two phases.]
• Anthropometric Assessment [Time frame: At 0th week, 6th week, and 12th week for each of the two phases.]
• Blood pressure [Time frame: At 0th week, 6th week, and 12th week for each of the two phases.]
• Liver Function [Time frame: At 0th week, and 12th week for each of the two phases.]
• Liver Function [Time frame: At 0th week, and 12th week for each of the two phases.]
• Kidney Function [Time frame: At 0th week, and 12th week for each of the two phases.]
• Kidney Function [Time frame: At 0th week, and 12th week for each of the two phases.]
• Kidney Function [Time frame: At 0th week, and 12th week for each of the two phases.]
• Kidney Function [Time frame: At 0th week, and 12th week for each of the two phases.]
• Lipid Profile [Time frame: At 0th week, and 12th week for each of the two phases.]
• Lipid Profile [Time frame: At 0th week, and 12th week for each of the two phases.]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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.
• Participants requiring medication for conditions not specified in exclusion criterion (2), who are unable to maintain a stable treatment regimen throughout the trial
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Quadruple blind

Primary purpose

Prevention

Study locations

Taiwan · 1 center

• Taipei Medical University — Taipei

Identifiers

NCT: NCT07229521 · N202412072

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗