No effect of fenugreek, bergamot and olive leaf extract on glucose homeostasis in patients with prediabetes: a randomized double-blind placebo-controlled study

INTRODUCTION: The main pathophysiologic mechanism of type 2 diabetes (T2D) is insulin resistance, which exists several years before T2D diagnosis. The term ‘prediabetes’ applies to patients with insulin resistance but without overt T2D. The improvement of glucose homeostasis in these patients may prevent or delay the development of T2D and its complications. Data suggest that fenugreek, olive leaf polyphenols and bergamot extract may improve carbohydrate metabolism. We examined the effect of an agent containing fenugreek, olive leaf polyphenols and bergamot extract (active agent) on glucose homeostasis in patients with prediabetes. MATERIAL AND METHODS: This was a single-center, randomized, double-blind, placebo-controlled trial; patients with prediabetes (N = 100) were randomized to treatment with the active agent or placebo. The primary efficacy endpoint was the change in glycated hemoglobin (HbA(1c)) at 6 months after treatment initiation. Secondary endpoints included changes in other parameters of glucose metabolism and lipid profile. RESULTS: Overall 87 patients completed the study. No significant change in HbA(1c) was observed in either treatment group. Similarly, fasting plasma glucose, insulin, homeostasis model assessment-insulin resistance (HOMA-IR) index and lipid profile remained unaltered in both groups. CONCLUSIONS: The administration of an agent containing fenugreek, olive leaf polyphenols and bergamot extract for 6 months did not improve glycemia or lipid parameters in patients with prediabetes.