Chapter 28 - Safety and Antidiabetic Efficacy of a Novel Trigonella foenum-graecum Seed Extract

Abstract

Fenugreek (Trigonella foenum-graecum Linn. family Fabaceae) is a unique medicinal plant used for several centuries for its broad spectrum efficacy in various diseases. The various parts of this plant are used as an herb, food, spice, and in traditional medicine. It has been repeatedly mentioned in Ayurveda for its broad spectrum health benefits. Especially, fenugreek seeds are known to exhibit potent antioxidant, hypoglycemic, and nephroprotective activities, as well as serve as an excellent membrane stabilizer, especially because of its content of novel furostanolic saponins. In our laboratories, we developed a novel, patented fenugreek seed extract (Fenfuro) enriched in approximately 45% furostanolic saponins. Broad spectrum safety studies and in vivo studies in type 2 diabetic (T2D) rats exhibited its broad spectrum safety and antidiabetic efficacy. Subsequently, we conducted a multicenter, randomized, placebo-controlled, double-blind clinical study in 154 male and female subjects with T2D over a period of 3months using a daily dose of Fenfuro 500mg bid. Fenfuro caused a significant reduction in both fasting plasma and postprandial blood sugar levels. A significant increase in fasting and postprandial C-peptide levels was observed as compared to baseline values, while no significant changes in fasting and postprandial C-peptide levels were observed between the two groups. Fenfuro did not exhibit any adverse events.