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CLINICAL STUDY 2 |
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A
double blind placebo controlled study |
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of the LifeWave™
technology |
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as
it relates to the improvement of
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strength and endurance in |
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high performance college
athletics. |
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By David Schmidt |
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President, LifeWave™ Products,
LLC |
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Abstract: |
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The LifeWave™ technology is a
new supplement and method for
the improvement of athletic
performance. LifeWave™ is a
means by which an individual may
substantially increase their net
strength endurance within as
quickly as the first use of the
product. To evaluate this
statement in an unbiased manner,
a double blind placebo
controlled study was
implemented. The principal
investigator of this study was
Coach Richard Shaughnessy,
strength and conditioning coach.
A standardized test was selected
to measure net gains in strength
endurance, and in this case the
exercise that was performed by
all athletes was a 225 lb. flat
Bench Press. The baseline data
for this test was collected on
Thursday June 26, 2003. The
comparative data was collected
on the following Wednesday July
2, 2003. Athletes were divided
into three groups: Control,
Placebo and Test. The Control
group was tested "as is" on both
of these testing days. The
Placebo group was given a set of
patches filled with water; this
group was unaware as to whether
or not the patches were real or
water filled. The Test group was
given a set of patches with the
LifeWave™ technology; again,
this group was unaware as to the
contents of the patches. It will
be emphasized that the athletes
using the LifeWave™ technology
used the product only once; the
test was performed within 10
minutes of first applying the
patches to the athletes. |
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Metabolism and ATP production
It is well known that in humans
in order for locomotion to occur
ATP must be available to the
muscle as well as all other
cells. The biochemistry of
metabolism is centered in the
synthesis of carbohydrates,
fats, proteins and nucleic
acids. For the purpose of this
discussion we shall concern
ourselves primarily with the
metabolism, utilization and
transport of fats as they
pertain to the production of
ATP.
In carbohydrate metabolism that
involves the glycolysis of
glucose molecules to pyruvic
acid for the purpose of feeding
the Krebs Cycle with high-energy
molecules, a process called
chemiosmosis is used to pump
protons across a membrane and
provide the energy for ATP
synthesis. The electron carrying
coenzyme molecules from the
Krebs Cycle enter the
chemiosmosis process, the
electrons are lost from the
coenzymes, the energy is used to
pump protons across the
mitochondrial membrane, and as
the protons flow to the outer
compartment of the mitochondrion
the energy from the electron
flow is used to synthesize ATP
molecules.
In contrast, in the metabolism
of fats precipitated by these
molecules being first broken
down into fatty acids and
glycerol molecules during
digestion the glycerol is
converted within the cell to
DHAP, an intermediary compound.
This is important in that the
DHAP may continue along a
metabolic pathway to pyruvic
acid, or the DHAP may reverse
and follow another pathway
towards becoming glucose.
Of concern in this discussion is
the use of fatty acids as a
metabolic reactant in the
mitochondria of the cell. In a
process known as beta-oxidation
(the fatty acid spiral) the
fatty acids are converted into
2-carbon units of acetyl-CoA. A
single fatty acid molecule
containing 16 carbon atoms will
yield 8 molecules of acetyl-CoA.
As each acetyl-CoA molecule
enters the Krebs cycle it is
metabolized to release its
energy. The ultimate formation
of ATP after beta-oxidation and
the Krebs Cycle is the same as
described above. The difference
in the sources of energy ?
carbohydrates or fats ? is in
that the energy yield from a
16-carbon fatty acid molecule is
considerable. With respect to an
athlete, it would be highly
desirable to be able to utilize
fatty acids as an energy source
in ATP production in that this
could potentially have a
desirable effect on stamina
and/or strength endurance.
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LifeWave™ principal of operation:
The LifeWave™ technology is a
passive non-invasive device
composed of water, Oxygen and
organic compounds that is worn
by the user much in the same
fashion as a band aid. This
product is not a transdermal
patch and it has been
demonstrated by the manufacturer
that none of the patch active
materials diffuses into or comes
in contact with the user.
The obvious question that arises
is how is it possible for such a
device to function other than a
placebo effect? It is postulated
by the manufacturer that the
LifeWave™ patch passively
modulates the oscillating low
energy magnetic field that
exists just above the surface of
the human epidermal layer. This
passive frequency modulation
creates a condition in which the
transport of long chain fatty
acids across the mitochondrial
membrane for subsequent
beta-oxidation and energy
production is triggered or
improved, thereby providing the
user with increased energy via
an increase in ATP production as
described above.
To understand how this
phenomenon could be possible,
let us re-examine the metabolic
process involving fatty acid
energy sources within the human
body. Fatty acids, a hydrocarbon
in which one of the hydrogen
atoms has been replaced by a
carboxyl group, are also
described as a monobasic
aliphatic acid made up of an
alkyl radical attached to a
carboxyl group. The metabolic
role of fatty acids may be
described in part in that fatty
acids are one of the primary
sources of energy for humans,
and through Beta-Oxidation, are
broken down into basic units of
energy. Of interest here is that
in order for this process to
work, fatty acids need to enter
the mitochondria for
Beta-Oxidation, and they are
unable to penetrate the inner
mitochondrial membrane by
themselves.
In addition to lipid metabolism,
the mitochondria is involved
with protein synthesis, and by
using either phase-contrast
microscopy or electron
microscopy, the mitochondrial
filaments or rods are seen to be
0.5 micrometers in diameter.
This information is significant
in that it is reported by the
manufacturer that in the
LifeWave™ technology, materials
and structures must be selected
based upon the resonant and
sympathetic frequencies of the
mitochondria during lipid
metabolism. In the human body,
to overcome the problem of the
inability of fatty acids to
transport from the cytosol
(soluble portion of the cell)
across the mitochondrial
membrane, it has been determined
by several researchers that
various nutrients are essential
to transport long chain fatty
acids from the cytosol across
the mitochondrial membrane for
fatty acid oxidation/metabolism
and energy production.
To obtain the desirable effect
of improving cell metabolism
passively (specifically,
increasing the rate of fatty
acid Beta-Oxidation by allowing
fatty acids to transport across
the mitochondrial membrane) the
manufacturer constructed a
device consisting of
orthomolecular organic
structures designed to passively
interact with the human magnetic
field for the purpose of
creating a system of frequency
modulation, much in the same way
that radio waves are modulated
to communicate audio
information. |
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Context:
At the time prior to the
beginning of this study the
relationship between the
LifeWave™ technology and
increases in stamina or strength
endurance was known by LifeWave™
Products, LLC but not known by
the athletes participating in
this study. |
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Objective:
To quantitatively assess the
effectiveness of the LifeWave™
technology in improving the
bench press performance of
college football athletes during
team training. |
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Methods:
Using a double blind randomized
placebo controlled study, a
total of 25 subjects, ages 18 to
22 years, volunteered to
participate for this test study.
Subjects baseline bench press
data was colleted after a brief
warm up period. Subjects were
asked to bench press a fixed 225
lb. weight until failure. In the
next session, subjects were
randomized into three groups
using a numbering system that
labeled participants as test
group, placebo group or control
group members with 25 completing
this two session study. The test
group was provided with non-transdermal
patches that contained the
LifeWave™ technology. The
Placebo group was provided with
non-transdermal patches that
contained water. A collection
team independent of the players
collected and monitored data
throughout the study process.
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Main Outcome Measures:
The LifeWave™ technology is a
non-invasive patch that
demonstrated the ability to
improve strength endurance in
the majority of athletes that
utilized it during a strenuous
weight lifting activity.
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Results:
Raw data collected from the
two-day study was as follows;
all numbers listed are
repetitions performed: |
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From the raw data collected in
the above table, and by removing
the highest and lowest scores
from each group, it was
determined that (1) The average
percentage change in strength
endurance in the Control group
was an increase in performance
of 8.9% from the baseline tests
to the comparative tests
(average 0.875 rep improvement);
(2) The average percentage
change in strength endurance in
the Placebo group was an
increase in performance of 13.8%
from the baseline tests to the
comparative tests (average 1.67
rep improvement); (3) The
average percentage change in
strength endurance in the Test
group was an increase in
performance of 43.2% from the
baseline tests to the
comparative tests (average 2.6
rep improvement). |
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In addition, the data shows the
following: |
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The above table gives us the
breakdown of athletes in each
group as it pertains to showing
whether or not an athlete showed
a decrease in performance from
baseline to comparative test,
remained the same in performance
from baseline to comparative
test, or showed an increase in
performance from baseline to
comparative test.
In the Control group we see that
20% of the participants showed a
decrease in performance during
the two-day study, 10% of the
participants maintained the same
level of performance during the
two-day study, and 70% of the
participants showed an increase
in performance during the
two-day study. In the Placebo
group we see that 12.5% of the
participants showed a decrease
in performance during the
two-day study, 25% of the
participants maintained the same
level of performance during the
two-day study, and 62.5% of the
participants showed an increase
in performance during the
two-day study. In the Test group
we see that 14.3% of the
participants showed a decrease
in performance during the
two-day study, 0% of the
participants maintained the same
level of performance during the
two-day study, and 85.7% of the
participants showed an increase
in performance during the
two-day study.
If we remove the data for the
individuals who both decreased
in performance and maintained
the same level of performance we
find that (1) in the Control
group, with respect to the 7
individuals who did show an
improvement in performance from
the baseline to the comparative
test the average increase in
strength endurance was 19.7%;
(2) in the Placebo group, with
respect to the 5 individuals who
did show an improvement in
performance from the baseline to
the comparative test the average
increase in strength endurance
was 30.8%; (3) in the Test
group, with respect to the 6
individuals who did show an
improvement in performance from
the baseline to the comparative
test the average increase in
strength endurance was 63.8%.
If we remove the data for the
individuals who both increased
in performance and maintained
the same level of performance we
find that (1) in the Control
group, with respect to the 2
individuals who decreased in
performance from the baseline to
the comparative test the average
decrease in strength endurance
was 27.8%; (2) in the Placebo
group, with respect to the 1
individual who decreased in
performance from the baseline to
the comparative test the
decrease in strength endurance
was 42.8%; (3) in the Experiment
group, with respect to the 1
individual who decreased in
performance from the baseline to
the comparative test the
decrease in strength endurance
was 6.2%. |
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Discussion:
Based on the data collected it
is evident that there are
several distinct differences in
athletic performance between the
three groups. With respect to
the simple averaging of
performance numbers, it is not
unusual that all three groups
experienced an increase in
strength endurance given the
nature of the test (athletes
were in a training session for
the upcoming football season).
With respect to the Placebo
group, a case could be made that
there was indeed a "Placebo
Effect" that took place;
athletes that wore the patch
product thought that they had
the real technology so hence
they made more of an effort to
perform. Given the data of the
average group performance
improvement of the Placebo group
of 13.8% (as compared to 8.9% in
the Control group) this would be
a reasonable spread in terms of
attainable improvements from the
baseline day to the comparative
day. With respect to the Test
group, there was indeed a
legitimate effect of the
LifeWave™ technology on athletic
performance; athletes that wore
the patch product experienced an
average improvement of 43.2% in
strength performance. The
spreads in average performance
numbers between the three groups
is significant and would tend to
indicate that the LifeWave™
technology played an important
role in improving strength
endurance in the test group.
Another indicator that the
LifeWave™ technology was having
a legitimate effect on athletic
stamina is evidenced in the
chart on page 4. In all three
groups we see that the majority
of the athletes improved in
performance; however, the
Control group and Placebo group
showed nearly identical
percentages of athletes that
improved, with 70% of the
Control group and 62.5% of the
Placebo group. By comparison in
the test group we see that 85.7%
of the participants experienced
an improvement in performance.
Given that the Test group had
the highest percentage of
members who recorded an
improvement in performance, with
85.7% of the members
demonstrating an improvement,
and that the average improvement
was significantly higher than
the other two groups (43.2%)
this would again indicate that
the LifeWave™ technology was
having a beneficial effect on
athletic performance.
Another important indicator with
respect to examining that the
LifeWave™ technology was having
a beneficial effect on athletic
performance is found when
looking at only those
individuals who increased in
performance or only those
individuals who decreased in
performance. In the Control
group we find that of those
individuals who did show an
improvement the average gain was
19.7%. In the Placebo group we
find that of those individuals
who did show an improvement the
average gain was close to the
Control group at 30.8%. In the
Test group we find that of those
individuals who did show an
improvement the average gain was
more than triple the Control
group and double the Placebo
group at 63.8%. This information
would indicate that the LifeWave™
technology was having a
beneficial effect on strength
endurance. This improvement is
dramatic in that the individuals
tested had only used the
LifeWave™ technology for 10
minutes prior to the test. |
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Conclusion:
Based on the data collected and
the results obtained it was
demonstrated that the LifeWave™
technology is a method for the
improvement of athletic
performance, and more
particularly a means by which an
individual may increase their
net stamina/strength endurance
output. The model utilized to
evaluate the technology was a
double-blind placebo controlled
study, with 25 college athletes
from the University football
team volunteering to participate
in this study. In this
evaluation of strength endurance
involving competitive athletes
both baseline and comparative
tests were performed prior to
any other type of physical
activity. Being that the
athletes had a very brief usage
of the LifeWave™ technology, an
additional study would prove to
be of interest as a comparison
to this test study to determine
what effect the LifeWave™
technology has on athletes that
incorporate LifeWave™ into their
daily training regime.
It was demonstrated that the
Test/LifeWave™ group using the
LifeWave™ technology showed the
highest percentage of
improvement in strength
endurance when averaging all
members, the highest percentage
of improvement in strength
endurance when averaging only
those members who showed an
improvement, and the lowest
percentage of decreased
performance when averaging only
those individuals who showed a
decline in performance. |
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