Clinical Study Results on SlimSmart
Why do we need studies?
The
Food and Drug Administration (FDA) requires that
drugs and "medical devices" be
thoroughly tested before they can be marketed.
This is because all drugs have side
effects which are sometimes severe. An appraisal
must be made to determine if the drug's efficacy
out-weighs its negative side effects.
Unfortunately
there are many herbal supplements and other
products on the market
with no scientific evidence that they are
effective or safe, and indeed, they may
have significant side effects. Since 1984, these
products have been classified as Food Additives and
do not require substantiation in
the form of scientific studies. Any of these
products COULD BE dangerous, so beware of
this situation.
Since SlimSmart is a behavior modification
device and exhibits no medical side-effects, it
is not controlled by the FDA. So, from this
standpoint, studies are not required, and SlimSmart
is in a category of extremely safe products.
The Federal Trade Commission (FTC) has been
attempting to eliminate bogus weight-loss schemes
that are rampant. You might see signs that read
"Lose 30 pounds in 30 days for $30"
on local telephone poles. Whenever possible, the
FTC will nail these con-artists with fines or
otherwise force them to discontinue their
advertising even if you eat nothing at all, that amount
of weight loss would not be achieved. We support the FTC in these
efforts by providing credible evidence that SlimSmart is safe and
effective, and we make no unrealistic claims.
Adaptra Corporation has performed a very
good blinded study to evaluate the
efficacy of SlimSmart with regard to weight-loss.
Experimental Protocol
The document that explains how the experiment is to be performed is
called the protocol, and determines the
procedures and methods that will be used in the scientific experiment.
In this study, the protocol used three
"blind" groups. The primary treatment
group received the SlimSmart device, one control
group received a placebo device, and one control
group received nothing except advice. The groups were considered blind
because they were not told which group they were in. However, since SlimSmart is
a behavior modification device, it was probably obvious to the SlimSmart group
that they were receiving a workable treatment. The Placebo group was told that
the fake device they were using was real.
All participants received the same dietary and
exercise advice. They were advised to eat healthy
foods (such as from the standard "food pyramid" and
to exercise, but were not required to
adhere to any specific dietary regimen or exercise regimen
in terms of food choices or specific exercises.
Most participants did not change their food
choices or exercise habits.
Participants were weighed and measured weekly at the clinic
and maintained their own weight records at home.
Waist, hips, body fat, and other measurements were also
taken in the clinic.
Data Analysis and Results
The data were analyzed by an independent statistician
who was unaware of the identities of the
treatments. After 6 weeks in the trial, the
subjects in the SlimSmart treatment group lost an
average of 6.5 lb. The participants in the
placebo control group lost an average of 1.5 lb.
The participants in the advice-only control group
lost 1.6 lb. These data were analyzed using ANOVA
and Tukey W. There was no significant difference
between the results of the placebo group and the
control group. However, the results of the
primary treatment group were statistically
significant to a 95% confidence level, and were
different from the control groups. This study is
continuing so as to show that the changes are
permanent. Many of these participants have continued to
lose up to about 15% of their original weight.
Again, note that these results
included NO REQUIRED EXERCISE. Your results
may be much better if you include exercise in
your program. We are not advocating that you avoid
exercise, but this was the way the study was
performed to isolate the effects of the SlimSmart
device without exercise.