Abstract
Objectives
To assess the effects of daily spilanthol (SA3X) supplementation over three months on muscle metrics and hormonal profiles in healthy males.
Methods
A total of 546 participants were randomized into SA3X or placebo groups, with or without structured exercise. Muscle size (mid-arm, chest, thigh circumference) and strength (bench-press, squatting) were measured pre- and post-intervention. Serum testosterone (total and free), estradiol, and SHBG levels were assessed.
Results
Among the participants in the exercise groups, those given SA3X had significant increases than those given placebo in terms of muscle size – mid-arm muscle circumference (10.54 vs. 7.21 cm; p<0.05), chest circumference (15.23 vs. 10.82; p<0.05) and thigh circumference (change in quadriceps area, 12.84 vs. 9.01 cm; p<0.05) and significant increases in strength in the bench-press (85.01 vs. 65.09 kg, p<0.05) and squatting exercises (155.04 vs. 95.06 kg, p<0.05). The participants assigned to the SA3X-no-exercise group had significant increases in muscle size than those assigned to the placebo-no-exercise group (p<0.05). A significant increase was also observed in total and free testosterone levels in SA3X group as compared to placebo (p<0.05). No significant increase was seen in estradiol levels. No significant adverse effects were observed among the participants.
Conclusions
SA3X supplementation significantly enhanced muscle size, strength, and testosterone levels in exercising participants compared to placebo, with additional benefits observed even without exercise.
Funding source: Stiriti Ayur Therpaies Pvt Ltd
Award Identifier / Grant number: STI1901IN
Acknowledgments
The authors express their gratitude to the participants and Stiriti Ayur Therapies Pvt Ltd, the manufacturer of SA3X, for the provision of the capsules used in the study.
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Research ethics: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee(s) and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. The study received ethical approval from Apollo Hospitals, Hyderabad via IRB no (AHJ-C-S-008/12–21). Additionally, the study was duly registered with the Clinical Trials Registry, India (CTRI/2021/05/033694). 
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Informed consent: Informed consent was obtained from all individuals included in this study. 
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Author contributions: K.G.M. and N.P. conceptualized the study; K.G.M. and N.R.P. developed methodology; K.G.M. and N.R.P. were responsible for software; K.G.M. and N.P. validated the data; K.G.M., N.R.P. and N.P. performed formal analysis; K.G.M. and N.R.P. investigated the data; K.G.M., N.R.P. and N.P. were responsible for resources and curated the data; K.G.M. prepared the original draft; K.G.M., N.R.P. and N.P. reviewed and edited the manuscript; K.G.M., and N.P. visualized the study; K.G.M., N.R.P. and N.P. were involved in project administration; N.P. supervised the study. All authors have read and agreed to the published version of the manuscript. 
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Use of Large Language Models, AI and Machine Learning Tools: None declared. 
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Conflict of interest: Authors state no conflict of interest. 
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Research funding: This study was supported by Stiriti Ayur Therpaies Pvt Ltd through research grant STI1901IN. 
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Data availability: The datasets generated and/or analyzed during the current study are available from the corresponding author on reasonable request. 
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