Cardiovascular DiseasesNCT06183307
Effects of Nattokinase on Inflammation and Cardiovascular Risk Markers in Patients With Dyslipidemia
A study testing Nattokinase in people with Cardiovascular Diseases and Dyslipidemias, run by Universidade Federal Fluminense at 1 site in Brazil.
Trial summary
The study aims to evaluate the effect of the nattokinase enzyme on inflammation and markers of cardiovascular risk in participants with dyslipidemia. A longitudinal double-blind randomized clinical trial will be carried out, involving hypertensive participants with dyslipidemia for two months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Dyslipidemias, Inflammation
- What is being tested?
- Nattokinase
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteBrazil
- Study dates
- 3 Aug 2024to 20 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both sexes;
- Over 18 years of age;
- Isolated increase in LDL-c (LDL-c ≥ 160 mg/dL);
- Isolated increase in triglycerides (TG ≥ 150 mg/dL or ≥ 175 mg/dL, without fasting);
- increased LDL-c (LDL-c ≥ 160 mg/dL)
- TG (TG ≥ 150 mg/dL or ≥ 175 mg/dL, without fasting);
- Reduction in HDL-c (men < 40 mg/dL and women < 50 mg/dL) alone or in association with an increase in LDL-c or TG. If TG ≥ 400 mg/dL.
- Individuals who are already using lipid-lowering therapy (statins or non-statins) will also be included.
Who cannot join
- Participants with autoimmune and infectious diseases, diabetes, cancer and AIDS;
- Pregnant women;
- Participants using catabolic drugs or antibiotics
- Participants on anticoagulant medication
- Participants using antioxidant vitamin supplements, prebiotic, probiotic or synbiotic and who are allergic to corn or soy starch.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Denise Mafra
Rio de Janeiro, Rio de Janeiro, 22260050
Ludmila cardozo, phd
About this study
The study aims to evaluate the effect of the nattokinase enzyme on inflammation and markers of cardiovascular risk in participants with dyslipidemia. A longitudinal double-blind randomized clinical trial will be carried out, involving hypertensive participants with dyslipidemia for two months.
Read the detailed description
Nattokinase has potent fibrinolytic/antithrombotic, antihypertensive, antiatherosclerotic, lipid-lowering, antiplatelet/anticoagulant and neuroprotective activities. Nattokinase is capable of inhibiting platelet aggregation by blocking the formation of thromboxane and inactivating the type 1 plasminogen activator inhibitory factor. Recently, it was proposed that nattokinase can attenuate oxidative stress and the inflammatory process in in vitro and animal models. However, there are no studies in dyslipidemic patients evaluating these data.
- Conditions
- Cardiovascular Diseases, Dyslipidemias, Inflammation
- Being tested
- Nattokinase, Placebo
- Keywords
- nattokinase, Cardiovascular Diseases, Inflammation, fibrinogen
- Medical subject headings
- Cardiovascular Diseases, Dyslipidemias, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NattokinaseDietary supplement
Participants will receive 1 capsule per day, providing the active nattokinase daily, at a dosage of 100mg, standardized at 2,000 Fibrinolytic Units for 2 months
PlaceboDietary supplement
The placebo group will receive 1 capsule per day with 100mg containing corn starch for 2 months.
| Study group | Role | What they receive |
|---|---|---|
| Nattokinase group | Experimental | Participants will receive 1 capsule per day, providing the active nattokinase daily, at a dosage of 100mg, standardized at 2,000 Fibrinolytic Units. Receives: Dietary Supplement: Nattokinase |
| Placebo Group | Placebo comparator | The placebo group will receive the same amount of 100mg placebo, at the same time, containing corn starch. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of inflammatory status in the participants
Get blood samples to evaluate the supplementation effects in inflammatory biomarkers: interleukin 6 (IL-6), tumor necrosis factor-alpha (TNF-alpha), C-reactive protein (CRP).
Measured: Baseline and 8 weeks
Secondary outcomes (1)
Change in plasma fibrinogen levels, lipid peroxidation and improvement in lipid profile.
Get blood samples to evaluate the supplementation effects in plasma fibrinogen, lipid profile (HDL-c, LDL-c, total cholesterol) and lipid peroxidation.
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2023
- Study start3 Aug 2024
- Primary completion20 Dec 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal Fluminense
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Rio de Janeiro State Research Supporting Foundation (FAPERJ)
- Responsible party
- Sponsor
- Investigators
- Ludmila Cardozo, PhD, Principal investigator, Universidade Federal Fluminense
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06183307
- Sponsor's protocol ID
- Denise Mafra17
- Status last verified
- May 2026
- First submitted
- 13 Dec 2023
- Last updated
- 14 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant data will not be public to other research unless necessary.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Nattokinase on Inflammation and Cardiovascular Risk Markers in Patients With Dyslipidemia
- ClinicalTrials.gov ID
- NCT06183307
- Acronym / sponsor ID
- Denise Mafra17
- Conditions
- Cardiovascular Diseases, Dyslipidemias, Inflammation
- Keywords
- nattokinase, Cardiovascular Diseases, Inflammation, fibrinogen
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Universidade Federal FluminenseUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Rio de Janeiro State Research Supporting Foundation (FAPERJ)
- Study start
- 3 Aug 2024 (actual)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 27 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to evaluate the effect of the nattokinase enzyme on inflammation and markers of cardiovascular risk in participants with dyslipidemia. A longitudinal double-blind randomized clinical trial will be carried out, involving hypertensive participants with dyslipidemia for two months.
Detailed description
Nattokinase has potent fibrinolytic/antithrombotic, antihypertensive, antiatherosclerotic, lipid-lowering, antiplatelet/anticoagulant and neuroprotective activities. Nattokinase is capable of inhibiting platelet aggregation by blocking the formation of thromboxane and inactivating the type 1 plasminogen activator inhibitory factor. Recently, it was proposed that nattokinase can attenuate oxidative stress and the inflammatory process in in vitro and animal models. However, there are no studies in dyslipidemic patients evaluating these data.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nattokinase group | Experimental | Dietary Supplement: NattokinaseParticipants will receive 1 capsule per day, providing the active nattokinase daily, at a dosage of 100mg, standardized at 2,000 Fibrinolytic Units. |
| Placebo Group | Placebo comparator | Dietary Supplement: PlaceboThe placebo group will receive the same amount of 100mg placebo, at the same time, containing corn starch. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Both sexes;
- Over 18 years of age;
- Isolated increase in LDL-c (LDL-c ≥ 160 mg/dL);
- Isolated increase in triglycerides (TG ≥ 150 mg/dL or ≥ 175 mg/dL, without fasting);
- increased LDL-c (LDL-c ≥ 160 mg/dL)
Key exclusion criteria (5 listed)
- Participants with autoimmune and infectious diseases, diabetes, cancer and AIDS;
- Pregnant women;
- Participants using catabolic drugs or antibiotics
- Participants on anticoagulant medication
- Participants using antioxidant vitamin supplements, prebiotic, probiotic or synbiotic and who are allergic to corn or soy starch.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NattokinaseParticipants will receive 1 capsule per day, providing the active nattokinase daily, at a dosage of 100mg, standardized at 2,000 Fibrinolytic Units for 2 months | Dietary supplement | Nattokinase group |
| PlaceboThe placebo group will receive 1 capsule per day with 100mg containing corn starch for 2 months. | Dietary supplement | Placebo Group |
Primary outcome
Change of inflammatory status in the participants
Time frame: Baseline and 8 weeks
Get blood samples to evaluate the supplementation effects in inflammatory biomarkers: interleukin 6 (IL-6), tumor necrosis factor-alpha (TNF-alpha), C-reactive protein (CRP).
1 secondary outcome
Change in plasma fibrinogen levels, lipid peroxidation and improvement in lipid profile.
Time frame: Baseline and 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: No. Participant data will not be public to other research unless necessary.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ludmila Cardozo, PhD principal investigator
Universidade Federal Fluminense
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nattokinase in people with Cardiovascular Diseases and Dyslipidemias, run by Universidade Federal Fluminense at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Denise Mafra, PhD (+5521985683003, dmafra30@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of inflammatory status in the participants (time frame: Baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.