[A clinical study on the effect of nattokinase on carotid artery atherosclerosis and hyperlipidaemia]
1Guangdong Online Hospital Clinic, Guangdong 2nd Provincial People's Hospital, Guangzhou 510317, China.
Abstract:
Objective: To evaluate the efficacy of oral nattokinase (NK) in the reduction of common carotid artery intimal medial thickness (CCA-IMT) and carotid artery plaque size and in lowering blood lipids, and to explore the underlying mechanism of actions of NK and its potential clinical use. Methods: All enrolled patients were from the Out-Patient Clinic of the Department of TCM at the 3(rd) Affiliated Hospital of Sun Yat-sen University. Using randomised picking method, all patients were randomly assigned to one of two groups, NK and Statin (ST) group. NK Group-patients were given NK at a daily dose of 6 000 FU and ST Group-patients were treated with statin (simvastatin 20 mg) daily. The treatment course was 26 weeks. CCA-IMT, carotid plaque size and blood lipid profile of the patients were measured before and after treatment. Results: A total of 82 patients were enrolled in the study and 76 patients (NK 39, ST 37) completed the study. Following the treatments for 26 weeks, there was a significant reduction in CCA-IMT and carotid plaque size in both groups compared with the baseline before treatment. The carotid plaque size and CCA-IMT reduced from(0.25±0.12)cm(2) to (0.16±0.10)cm(2) and from (1.13±0.12)mm to (1.01±0.11)mm, repectively. The reduction in the NK group was significantly profound (P<0.01, 36.6% reduction in plaque size in NK group versus 11.5% change in ST group). Both treatments reduced total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C) and triglyceride (TG). While the reduction in both groups was shown to be statistically significant (P<0.01), the reduction of TC, LDL-C and TG in ST group was significantly greater (P<0.05). In addition, NK significantly increased the level of high-density lipoprotein cholesterol (HDL-C) (P<0.05), in contrast, HDL-C in the ST group did not change. The lipid lowering effect observed in the NK group was not correlated to the reduction of CCA-IMT and carotid artery plaque size (r=0.35, P=0.09). Conclusions: Our findings from this pioneer clinical study suggests that daily NK supplementation is an effective way to manage the progression of atherosclerosis and potentially may be a better alternative to statins which are commonly used to reduce atherosclerosis and further to prevent cardiovascular attack and stroke in patients. The mechanism underlying the reduction of carotid atherosclerosis by NK may be independent from its lipid-lowering effect, which is different from that of statins.
Insights
Nattokinase (NK) significantly reduced carotid artery plaque and intima-media thickness more than statins. This study suggests NK may be a superior alternative for managing atherosclerosis progression and preventing cardiovascular events.
Area of Science:
- Cardiovascular Medicine
- Nutraceuticals
- Pharmacology
Background:
- Atherosclerosis, characterized by increased carotid artery intimal medial thickness (CCA-IMT) and plaque size, is a major risk factor for cardiovascular events.
- Statins are commonly prescribed to manage atherosclerosis by lowering blood lipids, but their efficacy and side effects warrant exploration of alternative treatments.
- Nattokinase (NK), a fibrinolytic enzyme derived from natto, has shown potential in cardiovascular health, but its clinical efficacy in atherosclerosis management requires further investigation.
Purpose of the Study:
- To evaluate the efficacy of oral nattokinase (NK) in reducing common carotid artery intimal medial thickness (CCA-IMT) and carotid artery plaque size.
- To assess NK's impact on blood lipid profiles, including total cholesterol (TC), LDL-C, HDL-C, and triglycerides (TG).
- To explore the underlying mechanisms of NK's action and its potential as an alternative clinical treatment for atherosclerosis.
Main Methods:
- A randomized controlled trial involving 82 patients, comparing daily oral nattokinase (6,000 FU) with simvastatin (20 mg) over 26 weeks.
- Measurements included CCA-IMT, carotid plaque size, and blood lipid profiles (TC, LDL-C, HDL-C, TG) assessed before and after the treatment period.
- Statistical analyses were performed to compare the efficacy of NK and statin groups in reducing atherosclerosis markers and lipid levels.
Main Results:
- Both NK and statin treatments significantly reduced CCA-IMT and carotid plaque size compared to baseline.
- Nattokinase demonstrated a significantly greater reduction in carotid plaque size (36.6%) and CCA-IMT compared to statins (11.5% change).
- While both treatments lowered TC, LDL-C, and TG, statins showed a more pronounced effect. Notably, NK significantly increased HDL-C, whereas statins did not.
Conclusions:
- Daily nattokinase supplementation is effective in managing atherosclerosis progression, showing superior results in reducing carotid plaque size and CCA-IMT compared to statins.
- NK's mechanism for reducing carotid atherosclerosis may be independent of its lipid-lowering effects, differentiating it from statin's primary action.
- Nattokinase presents a promising alternative to statins for atherosclerosis management and potentially for preventing cardiovascular attacks and strokes.
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