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 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...

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Published inPharmaceutics Vol. 14; no. 11; p. 2453
Main Authors Pickering, Emily, Steels, Elizabeth, Rao, Amanda, Steadman, Kathryn J
Format Journal Article
LanguageEnglish
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
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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.
AbstractList 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.
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.
Author Pickering, Emily
Steels, Elizabeth
Steadman, Kathryn J
Rao, Amanda
AuthorAffiliation 2 Evidence Sciences Pty, Ltd., Brisbane, QLD 4005, Australia
1 School of Pharmacy, University of Queensland, Brisbane, QLD 4102, Australia
3 School of Human Movement and Nutrition Sciences, University of Queensland, Brisbane, QLD 4102, Australia
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Issue 11
Keywords post-prandial glucose
Trigonella foenum-graecum
fasting blood glucose
type 2 diabetes
insulin
prediabetes
fenugreek
Language English
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Snippet Background: This was an exploratory study to assess the safety and efficacy of a specialized Trigonella foenum-graceum L. seed extract for supporting healthy...
Background: This was an exploratory study to assess the safety and efficacy of a specialized Trigonella foenum-graceum L. seed extract for supporting healthy...
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SubjectTerms 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
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Title 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
URI https://www.ncbi.nlm.nih.gov/pubmed/36432644
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