Effects of hydro-alcoholic extract of Fumaria parviflora Lam on gene expression and serum levels of inflammatory and oxidative stress parameters in patients with type 2 diabetes: A clinical trial

Abstract

Considering that metabolic disorders, insulin resistance, oxidative stress, and inflammation are the main characteristics of type 2 diabetes, it appears that Shahtare supplement may be advantageous due to its anti-inflammatory and antioxidant properties, as well as its potential to improve carbohydrate and fat metabolism. By enhancing insulin sufficiency, it holds promise for benefiting individuals with type 2 diabetes. Given the high prevalence of type 2 diabetes in Iran and the absence of interventional studies on the effectiveness of Shahtare hydroalcoholic supplement on inflammatory factors in patients with type 2 diabetes, this study aims to investigate the impact of Shahtare hydroalcoholic extract on changes in gene expression of inflammatory factors, anthropometric indicators, and body composition in patients with type 2 diabetes undergoing a low-calorie diet. Materials and Methods: This double-blind randomized clinical trial included 70 women aged 20-50 years (non-menopausal) and men aged 20-65 years with a BMI between 25 and 40 kg/m2 suffering from type 2 diabetes. The supplementary intervention lasted for two months. Subjects completed a personal profile questionnaire at the study's onset. Venous blood samples (5 ml) were collected from all patients at the beginning and end of the study, after 12-10 hours of fasting, to assess the effect of Shahtare supplement and placebo on the change in gene expression of inflammatory factors (BCL-2, Nrf-2, BAX, Nf-kB, MCP-1) according to the provided instructions. Results: Although fat mass (%) (FM), fat-free mass (FFM) (%), and fat-free mass (FFM:kg) significantly decreased in both study arms after the intervention, there were no significant differences between the groups for these parameters in the eighth week. Additionally, there were no significant intergroup or intragroup differences for fat mass (Kg) and total body water (TBW%) at the study's end. The intervention group exhibited a significant decrease in serum levels of inflammatory and oxidative stress parameters, including ICAM-1 (P=0.012), IL-6 (P=0.014), TNF-α (P=0.009), and MDA (P=0.022), compared to the placebo group at the study's conclusion based on the ANCOVA test adjusted for age, baseline values, and changes in caloric intake. Furthermore, the serum levels of antioxidant enzymes, including SOD (P=0.003) and GPX (P=0.037), as well as TAC (P=0.001), increased significantly in the intervention group compared to the placebo group after two months.