Evaluation of a Proprietary Fenugreek Extract, on Muscle Strength, Endurance, Total Serum Testosterone and Athletic Performance in Male Subjects during Resistance Training - A Randomized, Double Blind, Placebo Controlled, Comparative, Interventional, Prospective Study

Abstract

Background Fenugreek is known to improve muscle strength, stamina and serum testosterone level during resistance training.

Objectives A randomized, double blind, placebo controlled, comparative, interventional, prospective clinical study was conducted to evaluate efficacy and safety of a botanical extract of Fenugreek in Male Subjects during resistance training.

Methods Subjects were advised to take given product (FENUDAATTM or matching placebo) in a dose of 1 capsule (275 mg) twice daily after meals with water for 8 weeks. A total of 43 healthy participants (22 in FENUDAATTM group and 21 in placebo group) completed the study. Study subjects participated in a supervised 4-day per week resistance-training program for 8 weeks. The efficacy testing outcomes included serum testosterone (total) level, muscle strength and repetitions to failure, metabolic markers for anabolic activity (serum creatinine and blood urea nitrogen), and body fat percentage. Standard safety measurements such as adverse events monitoring, vital signs, hematology and biochemistry were performed.

Results A significant increase in 1 Repeat Measure (RM) Bench Press, 1 RM Leg Press responses and repetitions to failure in bench press and leg press was observed in the FENUDAATTM group, compared to Placebo group. A significant reduction in weight and BMI was observed in the FENUDAATTM group, compared to placebo group. A significant increase in total serum testosterone, strength, stamina, energy, and endurance was observed in the FENUDAATTM group, compared to placebo group. FENUDAATTM was safe and well tolerated as there were no adverse events reported.

Conclusion The study concludes that regular consumption of the FENUDAATTM Capsule improves serum testosterone, strength, stamina, energy, and endurance during resistance training.

Competing Interest Statement

The authors have declared no competing interest.

Clinical Trial

CTRI/2021/07/034548

Funding Statement

The study was funded by Lodaat Pharma, 1415 West 22nd Street-Tower Floor, Oak Brook, Illinois 60523 both financially and materially.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The study was conducted according to the guidelines of the Declaration of Helsinki, and approved by the Institutional, KVTR Ayurveda College and Hospital, Boradi, Dhule District, India. (Letter no. AMB/331/2021-22 dated 22/06/2021)

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Footnotes

sanjaytamolihotmail.com +91 93225 22252, drnbmundhegmail.com +91 98503 78206, drganeshkolherediffmail.com +91 96579 51629, kiranLodaat.com +1 630-852-7544, drrubytargetinstgmail.com +91 89755 33215

Data Availability Statement

The datasets generated and/or analyzed during the current study are available from the corresponding author on reasonable request.

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