A multicenter clinical study to determine the efficacy of a novel fenugreek seed (Trigonella foenum-graecum) extract (FenfuroTM) in patients with type 2 diabetes

  • Narsingh Verma Departments of Physiology and Medicine King George’s Medical University Lucknow, UP, India
  • Kauser Usman Departments of Physiology and Medicine King George’s Medical University Lucknow, UP, India
  • Naresh Patel Departments of Physiology and Medicine King George’s Medical University Lucknow, UP, India
  • Arvind Jain Departments of Physiology and Medicine King George’s Medical University Lucknow, UP, India
  • Sudhir Dhakre Departments of Physiology and Medicine King George’s Medical University Lucknow, UP, India
  • Anand Swaroop Cepham Research Center Piscataway NJ 08854
  • Manashi Bagchi Cepham Research Center Concord, CA 94521
  • Pawan Kumar Chemical Resources Panchkula, Haryana, India
  • Harry G. Preuss Departments of Biochemistry, Medicine and Pathology, Georgetown University Medical Center, Washington, DC
  • Debasis Bagchi University of Houston College of Pharmacy Houston, TX, USA
Keywords: Fenugreek seed extract (Fenfuro), type 2 diabetes (T2D), blood pressure, blood sugar, c-peptide, HbA1c, safety

Abstract

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: 25–60 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 post-prandial 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.

Keywords: fenugreek seed extract (Fenfuro); type 2 diabetes (T2D); blood pressure; blood sugar; C-peptide; HbA1c; safety

(Published: 11 October 2016)

Citation: Food & Nutrition Research 2016, 60: 32382 - http://dx.doi.org/10.3402/fnr.v60.32382

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Author Biographies

Narsingh Verma, Departments of Physiology and Medicine King George’s Medical University Lucknow, UP, India

Professor, Departments of Physiology and Medicine

King George’s Medical University
Lucknow, UP, India

Kauser Usman, Departments of Physiology and Medicine King George’s Medical University Lucknow, UP, India

Professor, Departments of Physiology and Medicine
King George’s Medical University
Lucknow, UP, India

Naresh Patel, Departments of Physiology and Medicine King George’s Medical University Lucknow, UP, India

Associate Professor, Departments of Physiology and Medicine
King George’s Medical University
Lucknow, UP, India

Arvind Jain, Departments of Physiology and Medicine King George’s Medical University Lucknow, UP, India

Associate Professor, Departments of Physiology and Medicine
King George’s Medical University
Lucknow, UP, India

Sudhir Dhakre, Departments of Physiology and Medicine King George’s Medical University Lucknow, UP, India

Associate Professor, Departments of Physiology and Medicine
King George’s Medical University
Lucknow, UP, India

Anand Swaroop, Cepham Research Center Piscataway NJ 08854

Director, Cepham Research Center

Piscataway, NJ 08854

 

Manashi Bagchi, Cepham Research Center Concord, CA 94521

Director, Cepham Research Center

Concord, CA 94521, USA

Pawan Kumar, Chemical Resources Panchkula, Haryana, India

Director, Chemical Resources

Panchkula, Haryana, India

Harry G. Preuss, Departments of Biochemistry, Medicine and Pathology, Georgetown University Medical Center, Washington, DC
Professor, Departments of Biochemistry, Medicine and Pathology, Georgetown University Medical Center, Washington, DC
Debasis Bagchi, University of Houston College of Pharmacy Houston, TX, USA

Debasis Bagchi, PhD, MACN, CNS, MAIChE, received his Ph.D. in Medicinal Chemistry in 1982. He is the Chief Scientific Officer at Cepham Research Center, Piscataway, NJ; an Adjunct Professor in the Department of Pharmacological and Pharmaceutical Sciences at the University of Houston College of Pharmacy, Houston, TX, and, an Adjunct Faculty in Texas Southern University, Houston, TX. He served as the Senior Vice President of Research & Development of InterHealth Nutraceuticals Inc, Benicia, CA, from 1998 till Feb 2011, and then as Director of Innovation and Clinical Affairs, of Iovate Health Sciences, Oakville, ON, till June 2013. Dr. Bagchi received the Master of American College of Nutrition Award in October 2010. He is the Past Chairman of International Society of Nutraceuticals and Functional Foods (ISNFF), Past President of American College of Nutrition, Clearwater, FL, and Past Chair of the Nutraceuticals and Functional Foods Division of Institute of Food Technologists (IFT), Chicago, IL. He is serving as a Distinguished Advisor on the Japanese Institute for Health Food Standards (JIHFS), Tokyo, Japan. Dr. Bagchi is a Member of the Study Section and Peer Review Committee of the National Institutes of Health (NIH), Bethesda, MD. Dr. Bagchi has 315 papers in peer reviewed journals, 27 books and 18 patents. Dr. Bagchi is also a Member of the Society of Toxicology, Member of the New York Academy of Sciences, Fellow of the Nutrition Research Academy, and Member of the TCE stakeholder Committee of the Wright Patterson Air Force Base, OH. Dr. Bagchi is the Associate Editors of the Journal of Functional Foods, Journal of the American College of Nutrition, and Archives of Medical and Biomedical Research, and also serving as Editorial Board Member of numerous peer reviewed journals, including Antioxidants & Redox Signaling, Cancer Letters, Toxicology Mechanisms and Methods, The Original Internist, and other peer reviewed journals.

Published
2016-10-11
How to Cite
1.
Verma N, Usman K, Patel N, Jain A, Dhakre S, Swaroop A, Bagchi M, Kumar P, Preuss H, Bagchi D. A multicenter clinical study to determine the efficacy of a novel fenugreek seed (<em>Trigonella foenum-graecum</em>) extract (Fenfuro<sup>TM</sup&gt;) in patients with type 2 diabetes. fnr [Internet]. 2016Oct.11 [cited 2019Apr.23];600. Available from: https://foodandnutritionresearch.net/index.php/fnr/article/view/977
Section
Original Articles