Effects of lemon balm extract on glycemic criteria, lipid profile, apolipoprotein B, apolipoprotein A-1, antioxidant capacity and hs-CRP in comparison with control group in patients with type II diabetes

This study aims to investigate the effect of Melissa officinalis extract on glycemic status, lipid profile, apolipoprotein B, apolipoprotein A1, total antioxidant capacity and hs-CRP in patients with type II diabetes. In this randomized double-blinded placebo-control clinical trial 70 patients with type 2 diabetes reffering to the Institute of Endocrinology and Metabolism will be included. Inclusion criteria are: Patients aged 20 to 65 years for both sexes; The body mass index less than 35 kg/m2; no pregnancy or lactation; triglycerides less than 400 mg/dl; HbA1c < % 8; using a common diabetes drug (metformin and glibenclamide). Exclusion criteria are: Lack of any co-disorders including cardiovascular, liver, renal, allergic and infectious diseases as well as thyroid disorders and glaucoma; taking non steroidal anti-inflammatory drugs (NSAIDS) or estrogen and progesterone. Patients will be randomly assigned to intervention or control groups. In intervention group, patients will receive capsules containing 350 mg Melissa officinalis extract twice per day for 3 months. While, patients at the control group will receive placebo capsules containing 350 mg toasted flour twice daily during 3 months. All laboratory test including glycemic status, lipid profile, apolipoprotein B, apolipoprotein A1, total antioxidant capacity and hs-CRP , in addition blood pressure and anthropometric indices will be measured at baseline and week 12 of the study. Also, the dietary intakes and physical activity will be measured.

Vice Chancellor for Research, Iran University Of Medical Sciences