Safety and Efficacy of Furosap®, a Patented Trigonella foenum-graecum Seed Extract, in Boosting Testosterone Level, Reproductive Health and Mood Alleviation in Male Volunteers

Abstract

Background

The medicinal herb fenugreek (Trigonella foenum-graecum) seeds, fortified with dietary fibers and furostanolic saponins including protodioscin, have demonstrated a significant contribution to human health. In our laboratories, Furosap^®, a patented 20% protodioscin-enriched extract was developed from fenugreek seeds.

Objective

In an open-label, one-arm, single-center longitudinal study, we examined the safety and efficacy of Furosap^® on free and total testosterone levels, fasting blood sugar, blood pressure, sperm count, motility and morphology, dihydroepiandrosterone sulfate (DHEA-S), sexual health, reflex erection, mood alleviation, mental alertness, and total blood chemistry analyses over a period of 12 weeks in healthy male volunteers.

Methods

Institutional Ethics Committee approvals and Clinicaltrials.gov registration were obtained. Effect of Furosap^® (500 mg/day) was examined of free and total testosterone levels, sperm count, motility and morphology, sexual health, mood and mental alertness, and total blood chemistry analyses in 100 healthy volunteers (age 35–60 Y) over a period of 12 consecutive weeks.

Results

No changes were observed in body weight and BMI. Both systolic and diastolic blood pressure, and DHEA levels significantly decreased. Free and bound testosterone levels improved significantly at 12 weeks of treatment. Sperm motility significantly increased at 8- and 12-weeks of treatment, while abnormal sperm morphology significantly decreased at 12-weeks of treatment. Mental alertness, mood, and reflex erection score significantly alleviated. An age-induced increasing effect was observed. Furthermore, cardiovascular health and libido significantly improved. Blood chemistry analyses exhibited broad spectrum safety. A decreasing trend was observed in total cholesterol, triglycerides, and VLDL levels, while an increasing trend was observed in HDL level at 12 weeks of treatment. LDL level decreased significantly at 12-weeks of treatment. No adverse events were observed.

Conclusion

Results demonstrate that Furosap^® is safe and effective in improving testosterone levels, cardiovascular health, healthy sperm profile, mental alertness in human male volunteers.

Keywords:

• Trigonella foenum-graceum
• fenugreek seeds
• Furosap®
• protodioscin
• testosterone booster
• mood alleviation
• safety

Acknowledgments

All authors that Dr. Apul Goel and Dr. Shreya Pant of Kings’ George Medical University for their assistance and contribution. The authors thank Ms. Kamaljit Kaur for her excellent coordination and technical assistance.

Authors’ contributions

Dr. S.N. Sankhwar (SNS), Professor & Head, Department of Urology, King George’s Medical University, Lucknow, Uttar Pradesh, India, conducted this investigation as the Principal Investigator with his esteemed clinical study team members in Kings George’s Medical Center. Dr. Apul Goel, Professor, Department of Urology, King George’s Medical University, served as the Co-Principal Investigator. Dr. Shreya Pant, MD, King George’s Medical University, served as the research assistant in this project.

Disclosure statement

SNS extends his sincere thanks to Dr. Apul Goel and Dr. S. Pant for their eminent contribution and assistance. Dr. D. Bagchi and Dr. M. Bagchi are independent coordinators, coordinated this investigation, reviewed all the data, and strategically prepared the manuscript. Mr. Pawan Kumar and Mr. Mehul Rungta of Chemical Resources Research & Development Department were intricately associated with this investigation.

Funding

The Project was funded by Chemical Resources, Panchkula, Haryana, India.

Consent to publish

All authors have read, consented, and approved the final manuscript for publication. This manuscript doesn’t contain any individual person’s data.

Availability of data and material

SNS have appropriately stored all the data in their Laboratories Storage Facility in Kings Georges Medical University, Lucknow, Uttar Pradesh, India.