AN EXPLORATORY STUDY OF THE SAFETY AND EFFICACY OF A TRIGONELLA FOENUM-GRAECUM SEED EXTRACT IN EARLY GLUCOSE DYSREGULATION: A DOUBLE-BLIND RANDOMIZED PLACEBO-CONTROLLED TRIAL.

Background: This was an exploratory study to assess the safety and efficacy of a specialized Trigonella foenumgraceum L. seed extract for supporting healthy blood glucose metabolism in a pre-diabetic cohort. Methods: Fifty-four participants were randomised to receive 500 mg/day of T. foenum-graecum seed extract or matching placebo daily for 12 weeks. Fasting blood glucose (FBG), post-prandial glucose (PPBG), HbA1c, fasting insulin (FI), post-prandial insulin (PPI) and C-peptide were assessed at baseline, week 6 and week 12. Lipid levels, liver enzymes and C-reactive protein (CRP), along with safety markers and tolerability were also assessed at baseline and week 12. Results: By week 12 there was a significant difference in FBG (p < 0.001), PPBG (p = 0.007) and triglycerides (p = 0.030) between treatment groups, with no changes in HbA1c (p = 0.41), FI (p = 0.12), PPI (p = 0.50) or C-peptide (p = 0.80). There was no difference in total cholesterol (p = 0.99), high-density lipoprotein (p = 0.35), low density lipoprotein (p = 0.60) or CRP (p = 0.79). There was no change in safety markers and the treatment was well tolerated. Conclusions: The results of the study indicated that T. foenum-graecum seed extract may influence blood glucose metabolism and larger studies are warranted to evaluate efficacy and potential mechanisms of action. [ABSTRACT FROM AUTHOR]