A multicenter clinical study to determine the efficacy of a novel fenugreek seed (Trigonella foenum-graecum) extract (Fenfuro™) in patients with type 2 diabetes
Engelsk titel: A multicenter clinical study to determine the efficacy of a novel fenugreek seed (Trigonella foenum-graecum) extract (Fenfuro™) in patients with type 2 diabetes
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Författare:
Verma, Narsingh
;
Usman, Kauser
;
Patel, Naresh
;
Jain, Arvind
;
Dhakre, Sudhir
;
Swaroop, Anand
;
Bagchi, Manashi
;
Kumar, Pawan
;
Preuss, Harry G
;
Bagchi, Debasis
Email: debasisbagchi@gmail.com
Språk: Eng
Antal referenser: 43
Dokumenttyp:
RCT
UI-nummer: 17050112
Sammanfattning
Background: Trigonella foenum-graecum (fenugreek) seeds are known to exhibit potent antioxidant,
hypoglycemic, and nephroprotective activities, as well as serve as excellent membrane stabilizers especially
because of their content of novel furostanolic saponins. Our previous studies exhibited the broad spectrum
safety and efficacy of Fenfuro, a novel T. foenum-graecum seed extract enriched in furostanolic saponins, in
type 2 diabetes (T2D) in rats.
Design: This multicenter, randomized, placebo-controlled, double-blind, add-on clinical study evaluated over
a period of 90 consecutive days the efficacy of Fenfuro (daily dosage: 500 mg bid) in 154 subjects (male: 108;
female: 46; age: 2560 years) with T2D.
Methods:This study examined the body weight, blood pressure, and pulse rate, as well as the efficacy of
Fenfuro on fasting and post-prandial plasma sugar (mg/dL), glycosylated hemoglobin (HbA1c), and fasting
and post-prandial C-peptide levels.
Results: Fenfuro caused significant reduction in both fasting plasma and post-prandial blood sugar levels.
Approximately 83% of the subjects reported decreases in fasting plasma sugar levels in the Fenfuro-treated
group as compared to 62% in the placebo group, while 89% of the subjects demonstrated reduction in postprandial
plasma sugar levels in the Fenfuro-treated group as compared to 72% in the placebo group. HbA1c
levels were reduced in both placebo and treatment groups. The decrease in HbA1c levels was significant
in both groups as compared to respective baseline values. A significant increase in fasting and post-prandial
C-peptide levels compared to the respective baseline values was observed, while no significant changes in
fasting and post-prandial C-peptide levels were observed between the two groups. No significant adverse
effects were observed by blood chemistry analyses. Furthermore, 48.8% of the subjects reported reduced
dosage of anti-diabetic therapy in the Fenfuro-treated group, whereas 18.05% reported reduced dosage of
anti-diabetic therapy in the placebo group.
Conclusion: In summary, Fenfuro proved safe and efficacious in ameliorating the symptoms of T2D in humans.