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

• Published in: Pharmaceutics Vol. 14; no. 11; p. 2453
• Main Authors: Pickering, Emily, Steels, Elizabeth, Rao, Amanda, Steadman, Kathryn J
• Format: Journal Article
• Language: English
• Published: Switzerland MDPI AG 14.11.2022; MDPI
• Subjects: Cardiovascular disease; Clinical trials; Diabetes; Double-blind studies; fasting blood glucose; fenugreek; Glucose; Herbal medicine; Insulin resistance; Metabolism; post-prandial glucose; prediabetes; Seeds; Trigonella foenum-graecum; type 2 diabetes; Hong Kong China; Australia; Lantau Island; post-prandial glucose; Trigonella foenum-graecum; fasting blood glucose; type 2 diabetes; insulin; prediabetes; fenugreek
• ISSN: 1999-4923; 1999-4923
• DOI: 10.3390/pharmaceutics14112453

Background: This was an exploratory study to assess the safety and efficacy of a specialized Trigonella foenum-graceum 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.