Mild to moderate hyperlipidemia – Dyslipidemia – Disorders of lipoprotein metabolism – Early cardiovascular disease – Prevention of atherosclerosis. Hyperlipidemia, unspecified
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Age 18–65 years Mild to moderate hyperlipidemia (LDL-C = 130 mg/dL and < 190 mg/dL or TG = 150 mg/dL and < 500 mg/dL) according to NCEP ATP III No lipid-lowering drugs in the past 4 weeks Ability to read, write, and sign informed consent BMI 18.5–35 kg/m²
Exclusion criteria
Exclusion criteria: Pregnancy or lactation Uncontrolled diabetes (HbA1c > 8%) Severe liver (ALT/AST > 3× ULN) or kidney disease (eGFR < 30 mL/min) Heart failure NYHA class III–IV Concomitant use of strong CYP3A4 inhibitors/inducers Known allergy to Fabaceae family plants Use of herbal supplements or antioxidants in the past 2 weeks Active malignancy Systemic corticosteroid use in the past month Unwillingness to participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in mean serum low-density lipoprotein cholesterol (LDL-C) level at week 8. Timepoint: Day 0 (baseline, before starting the capsules) and Day 56 ± 3 (end of week 8 of intervention). Method of measurement: 5 mL fasting (12–14 hours) venous blood sample, measured by enzymatic colorimetric method using Pars Azmoon commercial kit or equivalent on Hitachi 917 or Beckman Coulter AU5800 autoanalyzer, daily calibration and internal/external quality control. | — |
Countries
Iran (Islamic Republic of)
Contacts
Ilam University of Medical Sciences