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Nattokinase Atherothrombotic Prevention Study

Description

Objectives and Hypotheses: The goal of the proposed study is to determine under randomized controlled trial (RCT) conditions whether nattokinase reduces subclinical atherosclerosis and cognitive decline in healthy women and men. The investigators' hypotheses are: 1) Compared to placebo, nattokinase will show less subclinical atherosclerosis progression and cognitive decline in healthy women and men; 2) The reduction in subclinical atherosclerosis progression and cognitive decline with nattokinase will be correlated; and, 3) The reduction in progression of subclinical atherosclerosis and cognitive decline with nattokinase will be mediated through hemostatic, fibrinolytic and hemorheological factors as well as attenuation of inflammation, monocyte activation, vascular endothelium injury and activation of vascular endothelium by circulating monocytes. Specific Aims: To conduct a RCT to determine the effect of nattokinase on the progression of subclinical atherosclerosis (primary trial end point) and cognitive decline (secondary trial end point). Healthy non-demented women and men >55 years old without pre-existing symptomatic CVD and diabetes mellitus will be randomized over a 2 year period to oral nattokinase (2,000 fibrinolysis units) daily versus placebo in this double-blind, placebo-controlled trial; randomized treatment will be 3-years. The following 5 major specific aims will be completed: 1. To determine the effect of nattokinase on the progression of subclinical carotid artery atherosclerosis determined as the rate of change of the common carotid artery intima-media thickness (CIMT) and arterial stiffness in computer image processed B-mode ultrasonograms. 2. To determine the effect of nattokinase on cognitive decline determined with a neuropsychological battery designed to evaluate 7 cognitive domains including: attention, concentration, working memory, executive function; visuospatial/visuoconstructive skills; naming/semantic memory; and verbal and nonverbal episodic memory. 2a. To determine the effect of nattokinase on cognitive decline according to apolipoprotein (Apo) E e4 genotype. 3. To determine the association of subclinical atherosclerosis progression with cognitive decline. 4. To determine whether the effects of nattokinase on subclinical atherosclerosis and cognitive decline are mediated through hemostatic (fibrinogen, factor VIII, platelet activity), fibrinolytic (tPA, PAI-1, D-dimer), hemorheological (plasma and blood viscosity, red blood cell aggregation) and inflammatory (MCP-1, IL-8, TNFα, IL-1β, IL-10, monocyte cell surface markers CD11b/CD11c and VLA-4, expression of adhesion molecules VCAM-1 and ICAM-1 in cultured human aortic endothelial cells) factors as well as blood pressure.

Phase

N/A

Inclusion and Exclusion Criteria

  • Age >55 years
  • Male or postmenopausal female (no uterine bleeding for >6 months)

  • Clinical signs, symptoms, or personal history of CVD
  • Diabetes mellitus or fasting serum glucose >140 mg/dL
  • Plasma triglyceride levels >500 mg/dL
  • Uncontrolled hypertension (systolic blood pressure >160 mmHg or diastolic blood pressure >110 mmHg)*
  • Uncontrolled tachycardia or irregular heart rates (i.e., atrial fibrillation)
  • Thyroid disease (untreated)
  • Renal insufficiency (defined as serum creatinine >2.0 mg/dL)
  • Life threatening illness with prognosis <5 years
  • Current use of lipid-lowering medication
  • Current use of food supplements containing soy, soy protein, isoflavones or other phytoestrogens
  • Known sensitivity or allergy to soy or nuts
  • Regular aspirin or other antiplatelet medication use
  • Use of anticoagulants
  • Bleeding diatheses or tendencies

Sites

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