An Exploratory Study of the Safety and Efficacy of a <i>Trigonella foenum-graecum</i> 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 <i>Trigonella foenum-graceum</i> 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 o...

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Bibliographic Details
Main Authors: Emily Pickering, Elizabeth Steels, Amanda Rao, Kathryn J. Steadman
Format: Article
Language:English
Published: MDPI AG 2022-11-01
Series:Pharmaceutics
Subjects:
Online Access:https://www.mdpi.com/1999-4923/14/11/2453
Description
Summary:Background: This was an exploratory study to assess the safety and efficacy of a specialized <i>Trigonella foenum-graceum</i> 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 <i>T. foenum-graecum</i> 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 (<i>p</i> < 0.001), PPBG (<i>p</i> = 0.007) and triglycerides (<i>p</i> = 0.030) between treatment groups, with no changes in HbA1c (<i>p</i> = 0.41), FI (<i>p</i> = 0.12), PPI (<i>p</i> = 0.50) or C-peptide (<i>p</i> = 0.80). There was no difference in total cholesterol (<i>p</i> = 0.99), high-density lipoprotein (<i>p</i> = 0.35), low density lipoprotein (<i>p</i> = 0.60) or CRP (<i>p</i> = 0.79). There was no change in safety markers and the treatment was well tolerated. Conclusions: The results of the study indicated that <i>T. foenum-graecum</i> seed extract may influence blood glucose metabolism and larger studies are warranted to evaluate efficacy and potential mechanisms of action.
ISSN:1999-4923