300 Joseph Carrier, Vaudreuil-Dorion, Québec J7V 5V5 • Tel: 450.424.9992 • Fax: 450.424.9993 • www.immunotec.com
As listed in the 2016 Physicians’ Desk Reference (PDR)
Immunocal®
NUTRACEUTICAL
Glutathione precursor (Bonded cysteine™ supplement)
Powder Sachets
DESCRIPTION and CLINICAL PHARMACOLOGY
IMMUNOCAL® is a specially formulated undenatured whey
protein isolate. It holds several patents in the USA and
worldwide and is listed by the FDA in the category of GRAS
(generally recognized as safe). It assists the body in maintaining
optimal concentrations of glutathione (GSH) by supplying the
precursors required for intracellular glutathione synthesis. It is
clinically proven to raise glutathione values.
Glutathione is a tripeptide made intracellularly from its constituent amino acids L-glutamate, L-
cysteine and glycine. The sulfhydryl (thiol) group (SH) of cysteine is responsible for the
biological activity of glutathione. Provision of this amino acid is the rate-limiting factor in
glutathione synthesis by the cells since bioavailable cysteine is relatively rare in foodstuffs.
Immunocal® is a bovine whey protein isolate specially prepared so as to provide a rich source of
bioavailable cysteine. Immunocal® can thus be viewed as a cysteine delivery system.
The
disulphide
bond
in
cystine
is
pepsin
and
trypsin
resistant
but
may
be
split
by
heat,
low
pH
or
mechanical
stress
releasing
free
cysteine.
When
subject
to
heat
or
shearing
forces
(inherent
in
most
extraction
processes),
the
fragile
disulfide
bonds
within
the
peptides
are
broken
and
the
bioavailability
of cysteine is greatly diminished.
Glutathione
is
a
tightly
regulated
intracellular
constituent
and
is
limited
in
its
production
by
negative
feedback
inhibition
of
its
own
synthesis
through
the
enzyme
gamma-glutamylcysteine
synthetase,
thus
greatly minimizing any possibility of overdosage.
300 Joseph Carrier, Vaudreuil-Dorion, Québec J7V 5V5 • Tel: 450.424.9992 • Fax: 450.424.9993 • www.immunotec.com
Glutathione has multiple functions:
1
.
It
is
the
major
endogenous
antioxidant
produced
by
the
cells,
participating
directly
in
the
neutralization
of
free
radicals
and
reactive
oxygen
compounds,
as
well
as
maintaining
exogenous
antioxidants such as vitamins C and E in their reduced (active) forms.
2.
Through direct conjugation, it detoxifies many xenobiotics (foreign compounds) and
carcinogens, both organic and inorganic.
3
.
It
is
essential
for
the
immune
system
to
exert
its
full
potential,
e.g.
(1)
modulating
antigen
presentation
to
lymphocytes,
thereby
influencing
cytokine
production
and
type
of
response
(cellular
or
humoral)
that
develops,
(2)
enhancing
proliferation
of
lymphocytes
thereby
increasing
magnitude
of
response,
(3)
enhancing
killing
activity
of
cytotoxic
T
cells
and
NK
cells,
and
(4)
regulating apoptosis, thereby maintaining control of the immune response.
4
.
It
plays
a
fundamental
role
in
numerous
metabolic
and
biochemical
reactions
such
as
DNA
synthesis
and
repair,
protein
synthesis,
prostaglandin
synthesis,
amino
acid
transport
and
enzyme
activation.
Thus,
most
systems
in
the
body
can
be
affected
by
the
state
of
the
glutathione
system,
especially
the
immune
system,
the
nervous
system,
the
gastrointestinal
system
and
the
lungs.
INDICATIONS AND USAGE
IMMUNOCAL
®
is
a
natural
food
supplement
and
as
such
is
limited
from
stating
medical
claims
per
se.
Statements
have
not
been
evaluated
by
the
FDA.
As
such,
this
product
is
thus
not
intended to diagnose, cure, prevent or treat any disease.
Glutathione
augmentation
is
a
strategy
developed
to
address
states
of
glutathione
deficiency,
high
oxidative
stress,
immune
deficiency,
and
xenobiotic
overload
in
which
glutathione
plays
a
part
in
the
detoxification of the xenobiotic in question. Glutathione deficiency states include, but are not limited to:
HIV/AIDS,
infectious
hepatitis,
certain
types
of
cancers,
cataracts,
Alzheimer’s
Disease,
Parkinsons,
chronic
obstructive
pulmonary
disease,
asthma,
radiation,
poisoning
by
acetominophen
and
related
agents,
malnutritive
states,
arduous
physical
stress,
aging,
and
has
been
associated
with
sub-optimal
immune
response.
Many
clinical
pathologies
are
associated
with
oxidative
stress
and
are
elaborated
upon in numerous medical references.
Low
glutathione
is
also
strongly
implicated
in
wasting
and
negative
nitrogen
balance,
notably
as
seen
in
cancer,
AIDS,
sepsis,
trauma,
burns
and
even
athletic
overtraining.
Cysteine
supplementation
can
oppose this process and in AIDS, for example, result in improved survival rates.
CONTRAINDICATIONS
IMMUNOCAL® is contraindicated in individuals who develop or have known hypersensitivity to specific
milk proteins.
PRECAUTIONS
Each
sachet
of
IMMUNOCAL®
contains
nine
grams
of
protein.
Patients
on
a
protein-restricted
diet
need
to
take
this
into
account
when
calculating
their
daily
protein
load.
Although
a
bovine
milk
derivative,
IMMUNOCAL®
contains
less
than
1%
lactose
and
therefore
is
generally
well
tolerated
by
lactose
-
intolerant individuals.
300 Joseph Carrier, Vaudreuil-Dorion, Québec J7V 5V5 • Tel: 450.424.9992 • Fax: 450.424.9993 • www.immunotec.com
WARNINGS
Patients
undergoing
immunosuppressive
therapy
should
discuss
the
use
of
this
product
with
their
health
professional.
Individuals
with
the
autosomal-recessive
metabolic
disorder
cystinuria, are at higher risk of developing cysteine nephrolithiasis (1-2% of renal calculi).
ADVERSE REACTIONS
Gastrointestinal
bloating
and
cramps
if
not
sufficiently
rehydrated.
Transient
urticarial-like
rash
in
rare
individuals
undergoing
severe
detoxification
reaction.
Rash
abates
when
product
intake
stopped or reduced.
OVERDOSAGE
Overdosing on IMMUNOCAL® has not been reported.
DOSAGE AND ADMINISTRATION
For
mild
to
moderate
health
challenges,
20
grams
per
day
is
recommended.
Clinical
trials
in
patients
with
AIDS,
COPD,
cancer
and
chronic
fatigue
syndrome
have
used
30-40
grams
per
day
without
ill
effect.
IMMUNOCAL®
is
best
administered
on
an
empty
stomach
or
with
a
light
meal.
Concomitant intake of another high protein load may adversely affect absorption.
RECONSTITUTION
IMMUNOCAL
®
is
a
dehydrated
powdered
protein
isolate.
It
must
be
appropriately
rehydrated
before
use.
Ideally
consumed
after
mixing.
If
it
is
premixed
for
later
consumption,
it
should
be
refrigerated
and
consumed
shortly
after
mixing.
DO
NOT
heat
or
use
a
hot
liquid
to
rehydrate
the
product.
DO
NOT
use
a
high-speed
blender
for
reconstitution.
These
methods
will
decrease
the activity of the product.
Proper mixing is imperative. Consult instructions included in packaging.
HOW SUPPLIED
10 grams of bovine milk protein isolate powder per sachet.
30 sachets per box.
STORAGE
Store in a cool dry environment. Refrigeration is not necessary.
300 Joseph Carrier, Vaudreuil-Dorion, Québec J7V 5V5 • Tel: 450.424.9992 • Fax: 450.424.9993 • www.immunotec.com
REFERENCES
1.
Baruchel S, Viau G, Olivier R. et al. Nutraceutical modulation of glutathione with a humanized
native
milk serum protein isolate, Immunocal
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: application in AIDS and cancer. In: Oxidative Stress
in Cancer, AIDS and Neurodegenerative Diseases. Ed.; Montagnier L, Olivier R, Pasquier C. Marcel
Dekker Inc. New York, 447-461, 1998
2.
Bounous G, Kongshavn P. Influence of protein type in nutritionally adequate diets on the
development of immunity. In Absorption and Utilization of Amino Acids Vol.II. Ed. M. Friedman.
CRC Press, Inc., Fla. 2:219-32, 1989
3.
Bounous G, Gold P. The biological activity of undenatured whey proteins: role of glutathione. Clin
Invest Med 14:296-309, 1991
4.
Bounous G, Baruchel S, Falutz J. Gold P. Whey proteins as a food supplement in HIV-seropositive
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5.
Bounous G. Whey protein concentrate (WPC) and glutathione modulation in cancer treatment.
Anticancer Res. 20:4785-4792,2000
6.
Bounous G. Immunoenhancing properties of undenatured milk serum protein isolate in HIV
patients. Int. Diary Fed: Whey: 293-305, 1998
7.
Bray T, Taylor C. Enhancement of tissue glutathione for antioxidant and immune functions in
malnutrition. Biochem. Pharmacol. 47:2113-2123, 1994
8.
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with muscle wasting and immunological dysfunction. FASEB J: 11(13):1077-1089, 1997
9.
Herzenberg LA, De Rosa SC, Dubs JG et al. Glutathione deficiency is associated with impaired
survival in HIV disease. Proc Natl Acad Sci 94:1967-72,1997
10.
Kennedy R, Konok G, Bounous G et al.. The use of a whey protein concentrate in the treatment of
patients with metastatic carcinoma: A phase 1-II clinical study. Anticancer Res. 15:2643-50,1995
11.
Lands LC, Grey VL, Smountas AA. Effect of supplementation with a cysteine donor on muscular
performance. J. Appl. Physiol. 87:1381-1385, 1999
12.
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13.
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Pharmacother 29: 1263-73,1995
14.
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15.
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300 Joseph Carrier, Vaudreuil-Dorion, Québec J7V 5V5 • Tel: 450.424.9992 • Fax: 450.424.9993 • www.immunotec.com
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