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NCT02080520 · ClinicalTrials.gov registry record · NA
Nattokinase Atherothrombotic Prevention Study
A NA study, sponsored by University of Southern California.
- Completed
- Registry status
- NA
- Development phase
- 265
- Enrollment target
NCT02080520 is a NA study that has completed, run by University of Southern California. The registered enrollment target is 265 participants.
The verdict
NCT02080520, a NA study, has completed, sponsored by University of Southern California.
- COMPLETED
- Registry status
- NA
- Development phase
- 265 participants
- Enrollment target
Study Summary
The potential for nattokinase to "thin" blood and to reduce blood clotting by positive antithrombotic and fibrinolytic effects presents a unique opportunity to safely study such effects on cardiovascular disease and cognition. Unfortunately, such studies of antithrombotic and fibrinolytic pathways of prevention have been limited due to lack of safe compounds and the adverse reactions associated with current agents such as Coumadin. Nattokinase, an over-the-counter supplement used for cardiovascular health, is the most active functional constituent of natto, a fermented soy product. Natto has been consumed primarily by the Japanese for over 1000 years, a population with one of the lowest risks for cardiovascular disease and dementia. Cardiovascular disease and dementia remain the most challenging age-related health risks of the 21st century for Americans necessitating development of further effective preemptive strategies. Whether reducing the propensity for thrombus formation and/or increasing fibrinolytic activity can prevent the progression of atherosclerosis and cognitive decline has not yet been determined. Using nattokinase under primary prevention conditions, the investigators propose to conduct a randomized, double-blinded, placebo-controlled trial to determine whether decreasing atherothrombotic risk can reduce the progression of subclinical atherosclerosis and cognitive decline. The investigators propose to randomize 240 healthy non-demented women and men to nattokinase supplementation or to placebo for three years. The primary trial endpoints will be measurement of carotid arterial wall thickness and arterial stiffness, early changes of atherosclerosis that can be measured safely by non-invasive imaging techniques. The secondary trial endpoint will be ascertained through change in cognition measured by a neuropsychological battery. In addition, biochemical blood measurements and in vitro studies will be conducted to compare the effects of nattokinase rela
Interventions
- OTHER Placebo
- DIETARY_SUPPLEMENT Nattokinase
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 265 participants |
| Start Date | 2014-04 |
| Est. Completion | 2019-07-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02080520
The ClinicalTrials.gov registry entry for NCT02080520 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 265 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Southern California, which has 617 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02080520 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02080520 about?
NCT02080520 is a clinical study titled "Nattokinase Atherothrombotic Prevention Study". The potential for nattokinase to "thin" blood and to reduce blood clotting by positive antithrombotic and fibrinolytic effects presents a unique opportunity to safely study such effects on cardiovascular disease and cognition. Unfortunately, such studies of antithrombotic and fibrinolytic pathways o...
What is the current status of trial NCT02080520?
This trial is currently completed. It is a NA study. The enrollment target is 265 participants. The study started on 2014-04. Estimated completion is 2019-07-31.
What interventions are being tested in trial NCT02080520?
The interventions under investigation include: Placebo (OTHER), Nattokinase (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT02080520?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
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