RecruitingNot ApplicableNCT06183307

Effects of Nattokinase on Inflammation and Cardiovascular Risk Markers in Patients With Dyslipidemia


Sponsor

Universidade Federal Fluminense

Enrollment

48 participants

Start Date

Aug 3, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria8

  • 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.

Exclusion Criteria5

  • 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.

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Interventions

DIETARY_SUPPLEMENTNattokinase

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

DIETARY_SUPPLEMENTPlacebo

The placebo group will receive 1 capsule per day with 100mg containing corn starch for 2 months.


Locations(1)

Denise Mafra

Rio de Janeiro, Brazil

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NCT06183307


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