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Warm up 10 - 20-min 5-min 30-sec 5-min 5-min Recovery
Incremental Ramp Test
RPE of 17 is
reached
30-sec Sprint
5-min Time Trial
Warm up 60-min Recovery
1-hour Time Trial
EDGE
Control
pH
Lactate
Time points
7.9
7 . 7
7.5
7.3
7.1
6.9
6.7
6.5
Blood pH Units
40
35
30
25
20
15
10
5
0
Blood Lactate (mmol/L)
Baseline 0 min 2 min 4 min 6 min 8 min 10 min 12 min
n=17 14 min
n=14 16 min
n=11 18 min
n=6 Sprint
n=20 5-min TT
n=20 END
n=20
n=20
*
20
18
16
14
12
10
8
6
4
2
0
0 15 30 45 60
220
200
180
160
140
120
100
80
Time (min)
RPE
HR & RPE Intensity Long Duration Test Day
Heart Rate (bpm)
*
*
EDGE
Control
HR
RPE
Author Disclosure Information: M. Kern: Contracted Research - Including Principle Investigator; Ampersand Biopharmaceuticals LLC (DBA AmpHP)
FIGURE 1-BFIGURE 1-A
Mark Kern1, Lisa M. Misell2, Andrew Ordille1, Madeline Alm1, Brookell Salewske1
1San Diego State University, San Diego, CA, 2Ampersand Biopharmaceuticals, LLC, Thousand Oaks, CA (Sponsor: Michael Buono, FACSM)
DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, CROSSOVER PILOT STUDY EVALUATING THE IMPACTS OF SODIUM
BICARBONATE IN A TRANSDERMAL DELIVERY SYSTEM ON PHYSIOLOGICAL PARAMETERS AND EXERCISE PERFORMANCE
ABSTRACT
Oral sodium bicarbonate has been used for decades as an ergogenic aid by buffering muscle acid
production during exercise and subsequently delaying the onset of fatigue in athletes. However,
gastrointestinal side effects limit the use of sodium bicarbonate.
PURPOSE: This study evaluated the efcacy of a commercially available topical transdermal sodium
bicarbonate (TSB) lotion (Topical Edge™) which is claimed to be delivered through the skin using a
novel patent-pending transdermal delivery system for impacting exercise metabolism and performance.
METHODS: 20 trained cyclists (Category 1-3) and a professional triathlete participated in this
randomized, cross-over, double-blinded, placebo-controlled study. After application of TSB or
placebo lotions, subjects completed a variety of exercise and performance tests. On one day,
subjects completed a high-intensity series of exercise tests which included a ramped protocol until
reaching a rating of perceived exertion (RPE) of 17 out of 20, a 30-second sprint performance test,
and a 5-minute time trial performance test, with 5 minutes of recovery between tests. On a separate
day, subjects completed a 1-hour time trial. Heart rate, RPE, blood lactate and pH were assessed
before, during, and after performance testing.
RESULTS: Heart rate and RPE were signicantly (p<0.05) lower for TSB compared to placebo at
the 15-min mark of the 1-hour time trial, but not at other time points. When TSB was applied, lactate
was higher (p<0.05) after the high-intensity ramp, sprint and 5-min time trial series (10.8±3.2 mmol/L
versus 9.7±3.1 mmol/L for TSB and placebo, respectively). Similar effects were not observed after the
1-hour time trial. Signicance was not reached when examining performance differences (p>0.05).
CONCLUSIONS: Overall, the ndings from this study provide evidence that TSB can signicantly
impact blood lactate, heart rate and RPE during performance tests of varying intensity/length. These
signicant ndings support the ability of this lotion to transdermally deliver sodium bicarbonate, which
could allow athletes to avoid the side-effects of oral bicarbonate use. Further research is warranted
to substantiate these ndings and determine the most effective use for this commercially available
transdermal sodium bicarbonate lotion.
INTRODUCTION
Muscle acidosis is a contributor to reduced exercise capacity by causing subsequent muscle fatigue.
Oral sodium bicarbonate has been used for decades to buffer muscle acid production during exercise
and subsequently delay the onset of fatigue in athletes. Several studies of cyclists have demonstrated
the ergogenic effects of sodium bicarbonate. However, gastrointestinal side effects limit its use. A
commercially available sports lotion has recently been developed using the manufacturer’s
patent-pending transdermal delivery technology to deliver sodium bicarbonate through the skin in
order to impact performance and recovery without the limiting side-effects of oral use.
HYPOTHESIS: We hypothesized that the topical transdermal sodium bicarbonate (TSB) lotion (Topical
Edge PR™) would increase pH and lactate levels, and would confer a performance benet, similar to
the effects observed when oral sodium bicarbonate is ingested, but without the gastric side-effects.
METHODS
• 20 trained cyclists (Category 1-3) and a professional triathlete with an average VO2 Peak (VO2
mL/kg/min) of 58.9+/-7.2 participated in this randomized, cross-over, double-blinded, placebo-
controlled study.
• After application of Transdermal Sodium Bicarbonate (TSB) or placebo lotions, subjects
completed a variety of exercise and performance tests (Figure 1).
• Heart rate, RPE, blood lactate and pH were assessed before, during, and after performance testing.
Figure 1. Schematic of Study Protocol. Subjects completed both tests; A) High-intensity series of
exercise tests, and B) 1 hour time trial, on separate days, and for each study product (placebo or active).
RESULTS
• When TSB was applied, lactate was higher (p<0.05) after the high-intensity ramp, sprint and 5-min time
trial series (10.8±3.2 mmol/L versus 9.7±3.1 mmol/L for TSB and placebo, respectively) (Figure 2).
Figure 2. Blood pH and Lactate. When the transdermal sodium bicarbonate lotion was applied,
subjects had signicantly higher lactate levels following the high-intensity series of tests compared
to when applying placebo lotion. pH differences did not reach signicance.
• Heart rate and RPE were signicantly (p<0.05) lower for TSB compared to placebo at the 15-min
mark of the 1-hour time trial, but not at other time points (Figure 3).
• Signicance was not reached when examining other performance differences (p>0.05). This may
potentially be due to inadequate dosing or inadequate time allowed for the lotion to penetrate prior
to testing.
Figure 3. Heart Rate (HR) and Rate of Perceived Exertion (RPE). When the transdermal sodium
bicarbonate lotion was applied, subjects had signicantly lower HR and RPE at the 15 min. time
point of the 1 hour time trial despite completing the same total work load.
CONCLUSIONS
• Transdermal sodium bicarbonate signicantly impacted blood lactate, heart rate and RPE during
performance tests of varying intensity/length.
• Higher lactate levels and other signicant effects support the ability of this lotion to transdermally
deliver sodium bicarbonate.
• This route of bicarbonate delivery could allows athletes to avoid the side-effects of oral
bicarbonate use.
• Although promising, further research is warranted to substantiate these ndings and determine
the most effective dosing and time of application for this commercially available transdermal
sodium bicarbonate lotion.
ACKNOWLEDGMENTS
Ampersand Biopharmaceuticals, LLC (DBA AmpHP), the manufacturers of Topical Edge PR sodium
bicarbonate sports lotion, provided an unrestricted research grant and placebo and active products
for testing.