The clinical study
was conducted over a 14 day-period, starting
January 6, 2002 and ending April 18, 2002. Only
11 of the 20 participants fully complied with
the experimental protocol and completed the Bio-Chelat™
clinical study. Due to the limited number of
observations, David Quig Ph.D. of Doctors Data,
was unable to perform the appropriate
statistical analysis required for a legitimate
evaluation of the trial results. The German Bio-Chelat™
study utilized blood, while the U.S. study made
use of urine and fecal analysis. In retrospect,
and on close review of all data, Target Your
Health, Inc. noticeably sees, that the test
design was not fully appropriate because of the
specific pharmacokinetics of Bio-Chelat™. The
decision was therefore made to revise the
experimental design study, monitor patient
compliance more closely, and conduct another
clinical trial utilizing blood in conjunction
with Doctors Data.
Nevertheless Dr.
David Quig of Doctors Data stated: “Although the
U.S. study sample was insufficient, it appears
that the preliminary data that was collected
show that Bio-Chelat™ brought about the
elimination of heavy metals of the
participants.”
To understand how
the Bio-Chelat™ solution differs and works in
comparison to other chelators i.e. (DMPS,
DMSA, EDTA, etc), following is a summary
description of the pharmacokinetics.
Clinic-Pharmacological Data of Bio-Chelat™.
Pharmacokinetics:
Bio-Chelat™ contains a complex-forming agent (EDTA)
and an oxidative catalyst. The oxidative
catalyst has the following function:
1. To oxidize the SH-groups into SO3 2- groups
or SH-ions into sulfate. SH-groups or SH-ions
are ubiquitous in the GI tract and form very
strong bonds with heavy metals. The bonds of the
newly formed SO32-groups or sulfate groups are
reduced, thus allowing this very low
concentrated (homeopathic) dosage of EDTA to
easily bind with the heavy metal ions. In an
acidic environment (i.e. stomach, intestines
etc), EDTA forms a high complex bond with
mercury, cadmium and lead. Because of this,
heavy metals coming from the food, teeth roots,
bile etc. are chelated and excreted with the
feces.
By decreasing the
uptake of mercury ions into the blood stream and
creating a high electric-magnetic gradient in
the GI-tract, new heavy metal ions are pulled
from the body into the blood stream and
stomach/intestine and excreted (Law of
Isotonicity).
One example: When
taking Bio-Chelat™, (DL) the urine clearly
showed an increased amount of Cadmium and
Nickel. On the other hand, fecal excretion of
Cadmium, Mercury, Lead decreased.
Analysis: When Bio-Chelat™ is absorbed into the
GI tract, heavy metals are chelated and excreted
with the feces. This “clean-up” of the GI tract
can last between 24 hours to 1 week and depends
on the patient. During this period higher values
of excreted heavy metals can be seen. Once the
“clean-up” is completed, a lower concentration
of heavy metals is then found in the feces.
Lesser heavy metals are now absorbed into the
blood, creating an imbalance between the blood
and the deposits, which then will pull new heavy
metals into the blood stream from the deposits,
which are then excreted via the urine and feces.
As formulated by
Dr. Leman in the German study:
Bio-Chelat(TM)
will indirectly intensify the body’s physiologic
elimination mechanism of heavy metals. When
comparing values prior to Bio-Chelat™ intake,
due to the minimization of heavy metals into the
blood (blood doesn’t receive anymore metals from
the GI-tract), the balance between heavy metal
depots and blood is disturbed, and heavy metals
spill over (are pulled) into the blood, and are
then discarded via the kidneys and intestines.
An increase in the heavy metal concentration of
the urine and feces should not be measurable,
because even the blood level of heavy metals
should now be inferior compared to the
pre-therapeutic level. For long-term therapy,
this physiological mechanism can be utilized to
eliminate heavy metals.
Final Conclusion
The therapeutic
value of Bio-Chelat™ in the context of chelators
currently on the market is seen as follows:
a) Chelators work relatively fast, but they are
also very strong with a relative high washout of
important trace elements and a high degree of
specific side effects.
b) Bio-Chelat™ works much gentler and is easier
as most common chelators.
c) Bio-Chelat™ is not suitable for acute care of
heavy metal toxicity or a very high toxic ion
loads.
d) Bio-Chelat™ has its greatest value as a
middle and long-term therapy for chronic heavy
metal toxicity and especially in preventing
heavy metal toxicity through the today's overall
heavy metal exposition. For this it is the
optimal product.
e) The side effects of Bio-Chelat™ are minimal
when compared to the overall effect. Those side
effects can be totally eliminated through a
modification of intake and dose. No associated
risks are connected with the use of Bio-Chelat™.
Because of this,
Bio-Chelat™ is excellent in view of the numerous
patients carrying a chronic heavy metal ion
load. It is a necessary solution.
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