Topical EDGE Reduces Post Exercise Lactate Levels by 17.8% in Trained Cyclists ETScience, LLC 1 Suppleō, Inc 2

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Topical Edge Powered by Sodium Bicarbonate www.topicaledge.com Topical EDGE Reduces Post Exercise Lactate Levels by 17.8% in Trained Cyclists ETScience, LLC 1 Suppleō, Inc 2 1 E.

1 Topical Edge Powered by Sodium Bicarbonate Topical EDGE Reduces Post Exercise Lactate Levels by 17.8% in Trained Cyclists ETScience, LLC 1 Suppleō, Inc 2 1 E. Todd Schroeder, PhD and Albert F. Vallejo, PhD ETScience, LLC, Exercise Testing Specialists South Pasadena, CA 2 Ryan Beal, MD Suppleō, Inc, Topical Performance Technology Thousand Oaks, CA 0

2 SUMMARY Sodium bicarbonate has long been recognized as an ergogenic aid and its efficacy when taken orally is well studied. The challenge however lies in tapping into the scientific and clinical power of sodium bicarbonate without incurring the unwanted gastrointestinal side effects. In other words, it s one thing to demonstrate efficacy in a laboratory setting, but how does one avoid the gastrointestinal challenges, maximize the efficacy, and exploit the ergogenic potential in an everyday training or typical race situation? Suppleō, Inc., a topical performance technology company (Thousand Oaks, CA) developed an innovative approach. Their solution is Topical EDGE, a proprietary topical formulation containing sodium bicarbonate. With Topical Edge an athlete can target specific muscle groups while bypassing the oral route of administration. Topical Edge is an ergogenic aid that is not only efficacious, but useful in a typical training or racing environment. In this study, ETScience (ETS) assessed the efficacy of Topical Edge. ETS evaluated key performance and physiologic metrics in 15 well-trained cyclists. The investigation was a randomized, double-blind, placebo controlled, cross-over study of physiologic and performance measures during a cycling session. Most compelling, the application of Topical Edge to the lower extremity had a profound and statistically significant effect on reducing post exercise blood lactate by an average of 17.8%. In addition there were positive trends and correlations with key performance metrics (e.g., increased velocity, increased power, and lower perceived exertion) and importantly, there were no reported side effects using Topical Edge. Topical Edge is clearly influencing key physiologic and performance metrics in well-trained cyclists. Additional study is warranted to better understand the full potential of this product and technology. 1

3 TABLE OF CONTENTS INTRODUCTION... 3 METHODS... 4 RESULTS... 5 CONCLUSIONS... 6 ADDITIONAL RESOURCES... 7 FOR MORE INFORMATION

4 INTRODUCTION The Challenge. Intramuscular acidosis is a contributing factor to fatigue during athletic performance. Bicarbonate loading has been shown to be an effective way to buffer acidity and is an ergogenic strategy for athletes of many disciplines. It decreases the symptoms of burning in the muscle but more importantly, the reduced acidity has a number of important physiologic implications (increased power, increased endurance). Oral supplementation with sodium bicarbonate is well-studied and the ergogenic effect has been documented in well-designed studies across multiple sports and published in peer-reviewed literature. In short, in the laboratory setting supplementing with sodium bicarbonate makes sense. The challenge for athletes however, is translating that laboratory effect into the real world. Oral ingestion of sodium bicarbonate causes significant gastrointestinal distress including nausea, stomach pain, diarrhea, and vomiting. This becomes particularly important when you consider that the effective dose for a peripheral muscle requires ingesting an unnecessarily high oral (systemic) dose. Further, due to processing time, bioavailability, and the compound s short half-life, it is difficult to orally administer a sustainable dose. The Proposed Solution. Suppleō, Inc., a company focused on topical performance technology, developed an alternative approach. Suppleō leveraged the understood physiology and existing clinical data while solving the route of administration issue with a proprietary topical lotion: Topical Edge. Topical Edge is a proprietary topical sodium bicarbonate lotion that is applied directly to the skin over the muscle groups (e.g., thighs and calves in cycling) that are critical to an athlete achieving their personal best in their sport. The goal is to provide the ergogenic experience without the gastrointestinal challenges. The Purpose of this Study: Does it Work? The purpose of this study was to determine the efficacy of Topical Edge as an ergonomic performance aid in well-trained cyclists. The primary objective was to determine if topical application of sodium bicarbonate in the proprietary formulation can buffer lactate levels and improve cycling performance. 3

5 METHODS This study was a randomized, double-blinded, placebo-controlled, cross-over study independently conducted by ETScience. All testing was performed between June 15 th and June 29th, 2016 at the Movement Performance Institute in Los Angeles, CA and the CATZ Sports Performance Center in Pasadena, CA. 15 competitively trained cyclists between 21 and 43 years of age were recruited to participate in the study consisting of a cycling performance test conducted after Topical Edge and placebo topical application. Participants were screened for contraindications using a Physical Activity Readiness Questionnaire (PAR-Q) and provided verbal consultation as to the expectations of the testing. During this period, participants were familiarized with the topical application and exercise performance task of a 4km time trial on a Keiser M3 indoor cycle. Participants were scheduled to test in half hour blocks of time and fasted for at least 4 hours before testing. Prior to performance testing, the participant s age, weight, height, and body composition (Biospace, Inbody 720) were recorded, and a baseline lactate and heart rate (HR) were measured. The participant was then randomized to receive Topical Edge or placebo for the first testing session. After application of a standard volume Topical Edge or placebo to the quadriceps, hamstrings, and gastrocnemius of both legs, the participants waited for 30 minutes before starting the 4km time trial. After completion of testing session 1, the participants were scheduled to return within 48 hours to repeat the same testing procedures (session 2) under the testing condition (Topical Edge or placebo) that they did not complete at testing session 1. The following measurements were performed at rest: Heart rate (Polar Monitor) Blood lactate (Nova Biomedical Analyzer) The following measurements were performed immediately post exercise: Heart rate Blood lactate Cycle time Average power during the time trial Rating of perceived exertion (scale of 1-10 with 10 extremely difficult) 4

6 Table 2 shows the means and standard deviations with significance level comparing Group A to Group B. Table The 2 most shows compelling the means finding and standard of this study deviations is a statistically with significance significant level comparing decrease Group A (p=0.03) in RESULTS to post Group exercise B. The lactate most compelling levels from finding 11.2 of mmol/l this study to 9.2 is a mmol/l statistically (17.8% significant difference) decrease in the group (p=0.03) that received in post transdermal exercise lactate sodium levels bicarbonate. from 11.2 mmol/l A decrease to 9.2 in mmol/l blood lactate (17.8% is difference) the in the group that received transdermal sodium bicarbonate. A decrease in blood lactate is the result of a The buffering most effect compelling of the sodium finding bicarbonate of this study and is a may statistically be attributed significant to reduced decrease fatigue in result of a buffering effect of the sodium bicarbonate and may be attributed to reduced fatigue and improved post exercise performance. lactate levels Although from 11.2 there mmol/l were no to statistically 9.2 mmol/l significant (17.8% difference) changes in when and improved the participants exercise performance. received Topical Although Edge there compared were no statistically to placebo. significant Importantly, changes in cycle performance, there cycle performance, cycle time were no reported cycle was time reduced side was effects reduced by 2.4 seconds using by Topical 2.4 seconds and average Edge. and Furthermore, average power power increased there increased by 7 were by 7 watts when positive watts the when participants trends the participants received in cycling received transdermal performance: transdermal sodium cycle sodium bicarbonate. time was bicarbonate. These reduced These differences by 2.4 differences were seconds were measured and measured over average approximately over power approximately 5.5 increased minutes 5.5 by minutes of cycling. 7 watts of cycling. The when summative the The participants summative effects effects of received these of these changes topical changes over a typical sodium over cycling a typical bicarbonate performance cycling performance in the of proprietary of minutes formulation. minutes may have may These significant have significant differences beneficial beneficial were effects effects on on performance, measured performance, particularly over particularly in approximately elite athletes. in elite athletes. 5.5 minutes of cycling. TABLE 2 TABLE 2 GROUP MEAN PHYSIOLOGICAL AND PERFORMANCE MEASURES GROUP MEAN PHYSIOLOGICAL AND PERFORMANCE MEASURES Group Post HR (bpm) Post Lactate (mmol/l) Cycle Time (sec) Avg Power (W) RPE A (16.9) 11.2 (2.8) (55.9) (83.5) 8.8 (1.2) B (13.1) 9.2 (2.7) (50.5) (89.8) 8.7 (1.2) p-value Data are means and (standard deviations), A = placebo group, B = sodium bicarbonate Data are means group, HR and = (standard heart rate, deviations), bpm = beats A per = placebo minute, group, W = watts, B = RPE sodium = rating bicarbonate of perceived group, HR exertion = heart rate, bpm = beats per minute, W = watts, RPE = rating of perceived exertion Conclusion Conclusion Transdermal application of sodium bicarbonate lotion to the lower extremity had a profound effect on reducing post exercise blood lactate by 17.8%. Cycle performance Transdermal measures application of time of to complete sodium bicarbonate a 4km ride and lotion average to the power lower were extremity better when had participants a profound received effect on transdermal reducing sodium post exercise bicarbonate blood compared lactate to by placebo. 17.8%. These Cycle performance small changes over 5.5 measures minutes of time of to cycling complete could a 4km have ride an important and average impact power on performance were better when bouts participants extended over longer received transdermal periods of time. sodium bicarbonate compared to placebo. These small changes over 5.5 minutes of cycling could have an important impact on performance bouts extended over longer Future considerations: periods of time. 1) Because the athletes tested in this study were highly trained cyclist who are likely accustomed to high intensity exercise and have adapted to elevated lactate levels with Future considerations: enhanced clearance, it is possible that a greater effect may be observed in non-athletes 1) Because that the athletes have a more tested rapid in this and study greater were increase highly in trained blood lactate cyclist levels who are during likely accustomed unaccustomed high intensity exercise. exercise and have adapted to elevated lactate levels with enhanced clearance, it is possible that a greater effect may be observed in non-athletes that have a more rapid and greater increase in blood lactate levels during unaccustomed exercise. 5

7 CONCLUSIONS Based on the existing scientific and clinical data set, this study was conducted to see if a proprietary topical sodium bicarbonate formulation (Topical Edge) could yield ergonomic benefit in a practical manner (i.e., without gastrointestinal distress) in a study population of well-trained cyclists. The primary objective was to determine if topical application of sodium bicarbonate in the proprietary formulation can buffer lactate levels and improve cycling performance. The application of Topical Edge to the lower extremity had a profound effect on reducing post exercise blood lactate by an average of 17.8%. A decrease in blood lactate is the result of a buffering effect of the sodium bicarbonate contained in Topical Edge and may lead to reduced fatigue and improved exercise performance. Cycle performance measures of time to complete a 4km time trial and average power were better when participants received Topical Edge compared to placebo. There were no reported side effects. The changes observed over the relatively short ~5.5 minutes of cycling could have an even more significant beneficial impact on performance bouts when extended to a typical cycling performance of minutes, particularly in elite athletes. This study raises a number of interesting questions that further research could help delineate. Of particular interest is the ability to drive even greater performance improvements in longer exercise sessions (e.g., a 40km time trial), the potential shifting of metabolic energy substrate from carbohydrates to fats, and the influence of Topical Edge to alter Lactate Threshold (and corresponding performance metrics). Further study is warranted to fully understand the potential beneficial performance impact of Topical Edge. 6

8 ADDITIONAL RESOURCES Effect of lactate supplementation and sodium bicarbonate on 40-km cycling time trial performance. Northgraves MJ, Peart DJ, Jordan CA, Vince RV. J Strength Cond Res Jan;28(1): Effects of Sodium Bicarbonate on High-Intensity Endurance Performance in Cyclists: A Double-Blind, Randomized Cross-Over Trial. Egger F, Meyer T, Such U, Hecksteden A. PLoS One Dec 10;9(12):e Multiday acute sodium bicarbonate intake improves endurance capacity and reduces acidosis in men. Mueller SM, Gehrig SM, Frese S, Wagner CA, Boutellier U, Toigo M. J Int Soc Sports Nutr Mar 26;10(1):16. Nutritional Strategies to Modulate Intracellular and Extracellular Buffering Capacity During High-Intensity Exercise. Lancha Junior AH, Painelli Vde S, Saunders B, Artioli GG. Sports Med Nov;45 Suppl 1:S Recent Developments in the Use of Sodium Bicarbonate as an Ergogenic Aid. McNaughton LR, Gough L, Deb S, Bentley D, Sparks SA. Curr Sports Med Rep Jul-Aug;15(4): Sodium bicarbonate can be used as an ergogenic aid in high-intensity, competitive cycle ergometry of 1 h duration. McNaughton L, Dalton B, Palmer G. Eur J Appl Physiol Occup Physiol Jun;80(1):64-9. Sodium bicarbonate intake improves high-intensity intermittent exercise performance in trained young men. Krustrup P, Ermidis G, Mohr M. J Int Soc Sports Nutr Jun 4;12:25. The effects of sodium bicarbonate (NaHCO3) ingestion on high intensity cycling capacity. Higgins MF, James RS, Price MJ. J Sports Sci. 2013;31(9):

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Sodium bicarbonate ingestion and individual variability in time to peak ph

Sodium bicarbonate ingestion and individual variability in time to peak ph S. Andy Sparks 1, Emily Williams 1, Amy Robinson 1, Peter Miller 1, David Bentley 2, Craig Bridge 1 and Lars R. Mc Naughton 1