| Introduction: artificial sweeteners
are nowadays inevitable food
additives, since they provide
necessary food diversity to people
suffering from diabetes. aspartame
is the most frequently used
artificial sweetener ever and its
safety profile is much better than
that of saccharin or cyclamate. it
received marketing approval in
1973, but only 3 months later
aspartame was withdrawn because of
allegations based on improperly
designed experimental studies
dealing with its carcinogen effects
on rodent brain. however, extensive
studies using the same model did
not confirm such suspicions, and
aspartame received a second
marketing approval. epidemiological
studies: almost two decades later
an epidemiological study found a
relationship between aspartame and
an increased frequency of brain
tumors in humans. however, this
study included a short time span of
observation, and it did not
estimate actual intake of
aspartame, which led to loss of
validity. later on no
epidemiological studies found
correlation between aspartame use
and incidence of brain tumors in
humans. up to now the only safety
concern about aspartame, which
received valid scientific proofs,
is pro-seizure action of its
excessive intake. in patients with
epilepsy, excessive intake of
aspartame can decrease the
threshold for seizures or prolong
them once they appear. however, if
the intake is not above the
recommended level of 40 mg/kg
b.w./day, aspartame is well
tolerated even in this
subpopulation. conclusion: based on
detailed analysis of published
studies on safety of aspartame, it
should not be restricted, but used
in recommended amounts.
40mg/kg means over 3g per day will
be tolerated even by a person who
has epilepsy. now one liter of diet
cola has only 560mg! that means you
could have about 5 liters of diet
soda and tolerate it well even if
you were an epileptic patient! and
healthy humans can tolerate more.
regul toxicol pharmacol. 2002
apr;35(2 pt 2):s1-93. related
articles, links
aspartame: review of safety.
butchko hh, stargel ww, comer cp,
mayhew da, benninger c, blackburn
gl, de sonneville lm, geha rs,
hertelendy z, koestner a, leon as,
liepa gu, mcmartin ke, mendenhall
cl, munro ic, novotny ej, renwick
ag, schiffman ss, schomer dl,
shaywitz ba, spiers pa, tephly tr,
thomas ja, trefz fk.
medical and scientific affairs, the
nutrasweet company, mt prospect,
illinois 60056, usa.
harriett.h.butchko@nutrasweet.com
over 20 years have elapsed since
aspartame was approved by
regulatory agencies as a sweetener
and flavor enhancer. the safety of
aspartame and its metabolic
constituents was established
through extensive toxicology
studies in laboratory animals,
using much greater doses than
people could possibly consume. its
safety was further confirmed
through studies in several human
subpopulations, including healthy
infants, children, adolescents, and
adults; obese individuals;
diabetics; lactating women; and
individuals heterozygous (pkuh) for
the genetic disease phenylketonuria
(pku) who have a decreased ability
to metabolize the essential amino
acid, phenylalanine. several
scientific issues continued to be
raised after approval, largely as a
concern for theoretical toxicity
from its metabolic components--the
amino acids, aspartate and
phenylalanine, and methanol--even
though dietary exposure to these
components is much greater than
from aspartame. nonetheless,
additional research, including
evaluations of possible
associations between aspartame and
headaches, seizures, behavior,
cognition, and mood as well as
allergic-type reactions and use by
potentially sensitive
subpopulations, has continued after
approval. these findings are
reviewed here. the safety testing
of aspartame has gone well beyond
that required to evaluate the
safety of a food additive. when all
the research on aspartame,
including evaluations in both the
premarketing and postmarketing
periods, is examined as a whole, it
is clear that aspartame is safe,
and there are no unresolved
questions regarding its safety
under conditions of intended use.
egul toxicol pharmacol. 2001
dec;34(3):221-33. related articles,
links
click here to read
aspartame: scientific evaluation in
the postmarketing period.
butchko hh, stargel ww.
medical and scientific affairs, the
nutrasweet company, mt. prospect,
il 60056, usa.
prior to marketing, the safety of
the high-intensity sweetener
aspartame for its intended uses as
a sweetener and flavor enhancer was
demonstrated by the results of over
100 scientific studies in animals
and humans. in the postmarketing
period, the safety of aspartame was
further evaluated through extensive
monitoring of intake, postmarketing
surveillance of anecdotal reports
of alleged health effects, and
additional research to evaluate
these anecdotal reports and other
scientific issues. the results of
the extensive intake evaluation in
the united states, which was done
over an
8-year period, and the results of
studies done in other countries
demonstrated intakes which were
well below the acceptable daily
intakes set by the fda and
regulatory bodies in other
countries, as well as the joint
fao/who expert committee on food
additives. evaluation of the
anecdotal reports of adverse health
effects, the first such system for
a food additive, revealed that the
reported effects were generally
mild and also common in the general
population and that there was no
consistent or unique pattern of
symptoms that could be causally
linked to consumption of aspartame.
finally, the results of the
extensive scientific research done
to evaluate these allegations did
not show a causal relationship
between aspartame and adverse
effects. thus, the weight of
scientific evidence confirms that,
even in amounts many times what
people typically consume, aspartame
is safe for its intended uses as a
sweetener and flavor enhancer.
hell, this study shows aspartame is
safe even in people with
phenylketonuria.
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hum genet. 1994 apr;93(4):369-74.
related articles, links
neuropsychological and biochemical
investigations in heterozygotes for
phenylketonuria during ingestion of
high dose aspartame (a sweetener
containing phenylalanine).
trefz f, de sonneville l, matthis
p, benninger c, lanz-englert b,
bickel h.
kreiskrankenhaus reutlingen,
kinderklinik, universitat tubingen,
germany.
aspartame, a high intensity
sweetener, is used extensively
worldwide in over 5,000 products.
upon ingestion, aspartame is
completely metabolized to two amino
acids and methanol (approximately
50% phenylalanine, 40% aspartic
acid, and 10% methanol). the
effects of aspartame on cognitive
function, electroencephalograms
(eegs) and biochemical parameters
were evaluated in 48 adult (21 men,
27 women) heterozygotes for
phenylketonuria (pkuh), pkuh
subjects whose carr
arch intern med. 1989
oct;149(10):2318-24. related
articles, links
safety of long-term large doses of
aspartame.
leon as, hunninghake db, bell c,
rassin dk, tephly tr.
division of epidemiology, school of
public health, university of
minnesota, minneapolis.
safety of long-term administration
of 75 mg/kg of aspartame per day
was evaluated with the use of a
randomized, double-blind,
placebo-controlled, parallel-group
design in 108 male and female
volunteers aged 18 to 62 years.
subjects received either aspartame
or placebo in capsule form three
times daily for 24 weeks. no
persistent changes over time were
noted in either group in vital
signs; body weight; results of
standard laboratory tests; fasting
blood levels of aspartame's
constituent amino acids (aspartic
acid and phenylalanine), other
amino acids, and methanol; or blood
formate levels and 24-hour urinary
excretion of formate. there also
were no statistically significant
differences between groups in the
number of subjects expe
am fam physician. 1989
feb;39(2):201-6.
clinical safety of aspartame.
yost da.
university of arizona college of
medicine, tucson.
aspartame is a synthetic sweetener
commonly used in soft drinks and
many foods. even with high doses,
the metabolites of this sweetener
do not accumulate in toxic amounts.
to date, no definite symptom
complex has been connected with
aspartame, and it is considered
safe for use in all populations,
including diabetics,
phenylketonuric heterozygotes and
pregnant women.
*yawn*
diabetes care. 1989
jan;12(1):67-74. related articles,
links
aspartame metabolism in normal
adults, phenylketonuric
heterozygotes, and diabetic
subjects.
filer lj jr, stegink ld.
department of pediatrics, college
of medicine, university of iowa,
iowa city 52242.
this study reviews clinical studies
testing the effects of various
doses of aspartame on blood levels
of phenylalanine, aspartate, and
methanol in normal subjects and
known phenylketonuric
heterozygotes. the effect of
aspartame on the
phenylalanine-to-large neutral
amino acid ratio under various
feeding situations is shown. the
clinical studies of aspartame in
diabetic subjects are limited to
observations of its effects on
blood levels of glucose, lipids,
insulin, and glucagon. these
studies clearly demonstrate the
safety of this high-intensity
sweetener for use by humans.
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