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

Launched by UNIVERSIDADE FEDERAL FLUMINENSE · Dec 13, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of an enzyme called nattokinase on inflammation and heart health in people who have high levels of certain fats in their blood, known as dyslipidemia. The trial will involve participants who are between the ages of 18 and 74, and it will last for two months. To be eligible, individuals must have high levels of bad cholesterol (LDL) or triglycerides, or low levels of good cholesterol (HDL), even if they are currently taking medication to manage their cholesterol levels.

Participants in this study can expect to be part of a double-blind trial, meaning that neither they nor the researchers will know who is receiving the nattokinase treatment and who is receiving a placebo (a non-active treatment). This helps ensure that the results are fair and unbiased. It's important to note that certain individuals, such as those with autoimmune diseases, diabetes, or those taking specific medications, will not be able to participate in this trial. Overall, this study aims to better understand how nattokinase might help improve heart health and reduce inflammation in people with dyslipidemia.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.