Effect of Morus Alba leaves’s extract supplement on blood glucose, lipid profiles, HbA1c, insulin resistance ,inflammation factors and oxidative stress biomarkers in patients with type 2 diabetes

The aim of this study is to determine the effects of Mulbery alba leave extract on the metabolic profile, inflammatory factors, and biomarkers of oxidative stress and ALT and AST enzymes on patients with TDM2.

A randomized, double-blind, controlled clinical trial on 60 patients. Computer-generated random numbers were utilized for random assignment.

60 eligible patients with type 2 diabetes and referred to outpatient Naghavi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran will be selected in the study. Patients will be given 300 mg capsule of mulberry leaf extract twice a day (intervention group) or placebo (control group). Fasting blood samples will be taken from patients at the beginning of the study and 12 weeks after the intervention. Then, variables including fasting plasma glucose, serum insulin, HOMA-IR, lipid profile, QUICKI, CRP, NO, total antioxidant capacity, total plasma glutathione, MDA, hemoglobin A1C, and ALT and AST enzymes Will be measured.

Inclusion criteria: Patients with type 2 diabetes mellitus; aged 35-70 years. Exclusion criteria:Taking berry extract in the last three months; Changes in glucose-lowering drugs during the study; Taking anticoagulants; Pregnancy or lactation; Malignancies; Chronic liver disease.

The intervention consists of taking mulberry extract supplement (300 mg) twice per a day during 12 weeks, which is prepared by the Pharmaceutical Company of Barij Essence in Kashan, Iran, previously confirmed by the Food and Drug Administration. The placebo capsules contains starch produced by the same company.

Fasting plasma glucose; serum insulin; HOMA-IR; lipid profile; QUICKI; CRP; NO; total antioxidant capacity; total plasma glutathione; MDA; hemoglobin A1C

The updating process was done before publishing the paper to correct the registration information.

Barij Research Center of Medicinal Herbs

Computer-generated random numbers will be utilized for random assignment. Clinic-trained personnel will be performed all participant enrollment, random allocation and group assignment.

Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules.