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Pharmaceutics
Volume 14
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10.3390/pharmaceutics14112453
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Article

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

by
Emily Pickering
1,2,
Elizabeth Steels
1,2,*,
Amanda Rao
3 and
Kathryn J. Steadman
1
1
School of Pharmacy, University of Queensland, Brisbane, QLD 4102, Australia
2
Evidence Sciences Pty, Ltd., Brisbane, QLD 4005, Australia
3
School of Human Movement and Nutrition Sciences, University of Queensland, Brisbane, QLD 4102, Australia
*
Author to whom correspondence should be addressed.
Pharmaceutics 2022, 14(11), 2453; https://doi.org/10.3390/pharmaceutics14112453
Submission received: 5 October 2022 / Revised: 31 October 2022 / Accepted: 9 November 2022 / Published: 14 November 2022
(This article belongs to the Special Issue The Role of Natural Products on Diabetes Mellitus Treatment)
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Abstract

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.
Keywords: Trigonella foenum-graecum; fenugreek; prediabetes; type 2 diabetes; fasting blood glucose; post-prandial glucose; insulin Trigonella foenum-graecum; fenugreek; prediabetes; type 2 diabetes; fasting blood glucose; post-prandial glucose; insulin

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MDPI and ACS Style

Pickering, E.; Steels, E.; Rao, A.; Steadman, K.J. 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. Pharmaceutics 2022, 14, 2453. https://doi.org/10.3390/pharmaceutics14112453

AMA Style

Pickering E, Steels E, Rao A, Steadman KJ. 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. Pharmaceutics. 2022; 14(11):2453. https://doi.org/10.3390/pharmaceutics14112453

Chicago/Turabian Style

Pickering, Emily, Elizabeth Steels, Amanda Rao, and Kathryn J. Steadman. 2022. "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" Pharmaceutics 14, no. 11: 2453. https://doi.org/10.3390/pharmaceutics14112453

APA Style

Pickering, E., Steels, E., Rao, A., & Steadman, K. J. (2022). 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. Pharmaceutics, 14(11), 2453. https://doi.org/10.3390/pharmaceutics14112453

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