A Double-Blind, Randomized, Clinical Trial of the Effects of Fumaria parviflora Supplementation on Metabolic Parameters, Anthropometric Indices and Serum Levels of Leptin, Adiponectin and Resistin in Patients with Type 2 Diabetes

Abstract

Background: This study aimed to assess the effects of hydro-alcoholic extract of Fumaria parviflora (FP) on metabolic parameters, anthropometric measures, and serum concentrations of leptin, adiponectin, and resistin in patients with type 2 diabetes mellitus (T2DM). Method: Seventy patients with T2DM participated in the present clinical trial. The patients were randomly assigned to one of two groups, receiving either a 500 mg dose of hydro-alcoholic extract of FP or a placebo for 8 weeks. Anthropometric parameters, serum levels of metabolic factors, and serum concentrations of leptin, adiponectin and resistin were assessed pre-and post-intervention. The assessment of dietary intakes was conducted through three-day food records, which were subsequently analyzed via Nutritionist IV software. Results: FP treatment significantly led to decreased serum concentrations of fasting blood glucose (p = 0.008), insulin (p = 0.011), triglyceride (p = 0.037), total cholesterol (p = 0.008), low-density lipoprotein cholesterol (p = 0.016), leptin (p = 0.003) and resistin (p = 0.026), and homeostatic model assessment for insulin resistance (HOMA-IR) (p = 0.003). However, there was a statistically significant increase in serum concentrations of high-density lipoprotein cholesterol (HDL-C) (p = 0.019) and adiponectin (p = 0.032), as well as quantitative insulin sensitivity check index (p = 0.014) in the FP group compared to the placebo. No significant differences were observed between the groups for anthropometric indices, hemoglobin A1c (HbA1c), serum levels of liver enzymes, blood urea nitrogen, urea, creatinine, and daily dietary intakes at week eight. Conclusion: FP supplementation (500 mg/day) combined with calorie restriction for 8 weeks effectively improved glycemic indices, lipid profile, and serum levels of leptin, resistin and adiponectin in T2DM patients. Trial registration: Iranian Registry of Clinical Trials: IRCT20130610013612N11.