Int J Med Sci 2017; 14(1):58-66. doi:10.7150/ijms.17256 This issue
1. Department of Medicine, BBD University, Lucknow, India
2. Metabolic Physician, SHK Diabetes Clinic & Research Center, Lucknow, India
3. Department of Physiology, King George's Medical University, Lucknow, India
4. Cepham Research Center, Piscataway, NJ, USA
5. Georgetown University Medical Center, Washington, DC, USA
6. Chemical Resources, Panchkula, Haryana, India
7. University of Houston College of Pharmacy, Houston, TX, USA
Background: Dietary fiber rich fenugreek (Trigonella foenum-graecum) seeds have exhibited cardioprotective, hypolipidemic and other health benefits. Furosap (FS), an innovative, patented, 20% protodioscin-enriched extract was developed in our laboratory from fenugreek seeds. This study examined the free and total testosterone levels, sperm profile and morphology, sexual health, mood and mental alertness, and broad spectrum safety parameters of FS in 50 male volunteers following supplementation over a period of 12 weeks.
Methods: Institutional Review Board (IRB) and other regulatory approvals were obtained for our study. This one-arm, open-labelled, multi-center study was conducted in 50 male volunteers (age: 35 to 65 years) over a period of 12 weeks to determine the efficacy of FS (500 mg/day/subject) on free and total testosterone levels, sperm profile, sperm morphology, libido and sexual health, mood and mental alertness, and broad spectrum safety parameters.
Results: Free testosterone levels were improved up to 46% in 90% of the study population. 85.4% of the study population showed improvements in sperm counts. Sperm morphology improved in 14.6% of volunteers. Majority of the subjects enrolled in the study demonstrated improvements in mental alertness and mood. Furthermore, cardiovascular health and libido were significantly improved. Extensive safety parameters were evaluated which included blood chemistry data. No significant changes were observed in serum lipid function, cholesterol, triglyceride, HDL and LDL levels, hemogram (CBC), hepatotoxicity and nephrotoxicity.
Conclusion: Overall, the results demonstrate that FS, enriched in 20% protodioscin, is safe and effective in attenuating testosterone levels, healthy sperm profile, mental alertness, cardiovascular health and overall performance in human subjects.
Keywords: Fenugreeks seed extract (FurosapTM), Protodioscin, Testosterone, Sperm profile, Mental alertness, Mood, Cardiovascular health, Safety