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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: 2402 Board #238 June 1 11

Authors:
  • Dyve Biosciences
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
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7 . 7
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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
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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 efcacy 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 signicantly (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. Signicance was not reached when examining performance differences (p>0.05).
CONCLUSIONS: Overall, the ndings from this study provide evidence that TSB can signicantly
impact blood lactate, heart rate and RPE during performance tests of varying intensity/length. These
signicant 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 manufacturers
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 benet, 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 signicantly higher lactate levels following the high-intensity series of tests compared
to when applying placebo lotion. pH differences did not reach signicance.
Heart rate and RPE were signicantly (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).
Signicance 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 signicantly 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 signicantly impacted blood lactate, heart rate and RPE during
performance tests of varying intensity/length.
Higher lactate levels and other signicant 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.
... With that being said, there were no differences in appetite hormones or perceptions preexercise during either session, nor were there differences in the AUC for gastrointestinal distress between sessions (data not shown), suggesting the consumption of NaHCO 3 preexercise had negligible confounding effects, if any. Nonetheless, future work should consider recent developments in NaHCO 3 delivery through topical creams (30,37), which may allow manipulation of blood lactate levels independent of gastrointestinal side effects. Another potential limitation is that we only controlled for physical activity in the 24 h before data collection, and while previous work suggests that this should occur for at least 72 h before to ensure residual effects of exercise on appetite have diminished (43), we failed to observe baseline differences between exercise sessions, suggesting this had little measurable impact. ...
Article
High-intensity exercise inhibits appetite in part via alterations in the peripheral concentrations of the appetite-regulating hormones acylated ghrelin, active glucagon-like peptide-1 (GLP-1), and active peptide tyrosine-tyrosine (PYY). Given lactate may mediate these effects, we utilized sodium bicarbonate (NaHCO 3 ) supplementation in a double-blind, placebo controlled, crossover design to investigate lactate's purported role in exercise-induced appetite suppression. Eleven males completed two identical high-intensity interval training sessions (10 x 1 min cycling bouts at ~90% heart rate maximum interspersed with 1 min recovery), where they ingested either NaHCO 3 (BICARB) or sodium chloride (NaCl) as a placebo (PLACEBO) pre-exercise. Blood lactate, acylated ghrelin, GLP-1, and PYY concentrations, as well as overall appetite were assessed pre-exercise and 0, 30, 60, and 90 min post-exercise. Blood lactate was greater immediately (P<0.001) and 30 min post-exercise (P=0.049) in the BICARB session with an increased (P=0.009) area under the curve (AUC). The BICARB session had lower acylated ghrelin at 60 (P=0.014) and 90 min post-exercise (P=0.016) with a decreased AUC (P=0.039). The BICARB session had increased PYY (P=0.034) with an increased AUC (P=0.031). The BICARB session also tended (P=0.060) to have increased GLP-1 at 30 (P=0.003) and 60 min post-exercise (P<0.001) with an increased AUC (P=0.030). The BICARB session tended (P=0.059) to reduce overall appetite, though there was no difference in AUC (P=0.149). These findings support a potential role for lactate in the high-intensity exercise-induced appetite-suppression.
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