Note: Descriptions are shown in the official language in which they were submitted.
2~93~3
8 P ~ C I F I C A T I O N
TITLE
"IMPROVED HIGH PROTEIN LIQUID NUTRITION FOR
P~.TIENTS WITH ELEVATED WOUND HEALING REQUIREMENTS"
BACKGROUND OF THE INVENTION
The present invention relates generally to liquid
nutritional products. More specifically, the present
invention relates to high protein liquid nutritional
products.
~ number of high protein liquid nutritional products
exist for use in meeting certain reguirements o~
patients. For example, Replete~ high protein liquid
nutrition and Replete~ with fiber complete high protein
liquid nutrition, both available from Clintec Nutri~ion
Company, Deerfield, Illinois, provide ready-to-use
formulas for the comple~e, or supplemental-, tube ~eeding
of a patient. These products provide nutritional
formulas that can support the healing or repletion needs
of a patient.
Other formulations that are available include
Traumacal~ by Mead Johnson that is a high protein formula
allegedly designed to meet ~he special metabelic needs
of a trauma patient. Impact~ frsm Sandoæ al~o allegedly
provides a nutritional product for trauma patients.
Another available nutritional pxoduct is Jevity from
Ross.
Clinicians have noted that extremely malnourished
patients often have delayed ~ound healing. Wound healing
is a complex process ~or grow~h and regeneration. Wound
healing is a~ected to a great extent by metabolic and
nutritional factors. Indeed, e~n non-overt malnutrition
can have physiological effects on wound healing.
2~3~
One of the difficul~ies in insuring that a pati~nt
is provided with sufficient nutri~ion during increased
wound healing requirements is that certain key metaholic
nutritional abnormalities may occur acutely and may not
be accompanied by a specific, readily recognizable
symptom or physical sign. They would only ~e
recognizable by biochemical, physiological, and
immunological measurements. ~owever, wound healing may
be affected.
In certain circumstances ~nd for certain types of
patients, presently available, high nutritional products
may not meet all of the necessary nutritional and
metabolic needs of the patient. This is true even with
respect to formulations specifically designed for trauma.
S ~ Y OF THE INVENTION
The present inventi3n provides a product that is
specifically directed to meet the spe~ial metabolic needs
of patients with increased wound healing re~uirements.
The present invention is ~pecifically directed to
~0 patient~ having elevat~d wound healing reguirements that
may be du~ to the following conditiora: trauma; burns;
pressure ulcers: post-surgical wound care; cancer: and
repletion of lean body mass losses of greater than 15%.
To this end, th~ present invention provides a high
protein liquid nutrition for patients with elevated wound
healing require~enl:s comprising per 1,000 Xc:al: a
protein ~ource: a fat ~ource: a carbohydrate soUrce; a
zinc sourae providing at least approximatl3ly 150% of the
USRDA of ZillC; a Vitamin C :30urce providing at lea~t
approxi~ately 500% of th~ USRDA of Vitamin C: a selenium
source pr~vidiny at least approximately 100 mcg o~
selenium: a Vitamin A ~;ource providing at least
approximately 145% o~ the IJSRDA of Vitamin A, the vitamin
2~3~
-- 3 --
source includes a beta-carotene source providing at
le2st approximately 1.5 mg of ~eta-carotene; and a source
o^ t:~liamine providing at least approximately 200% of the
USP~. of thiamine.
In an embodiment, the high protein liquid nutrition
coDposition includes a source of fiber.
In an embodiment of th~ high protein liquid
nutrition composition, the fat source includes
approximately 0% to about 30% of the total caloric fat
content as MCTs. Preferably, the composition includes
25~ of the~caloric content of the fat source as ~CTs.
Further, with respect to the fat source, in an
e~bodiment, pref~rably, the ratio of n-6 to n-3 fatty
acids is 2:1 to 10~
In an embodiment, the liquid nutrition composition
includes at least approximately 100% of the U~RDA of
calcium and phosphorus.
In an embodiment, the liguid nutrition composition
includes at least approximately 140 ~cg of chromium and
approximately 220 mcg of moly~denum per 1,000 Kcal~
In an embodiment, a ~ethod ~or treating elevated
wound healing requirement~ in a patient in n~ed of ~ame
is provided. The meth~d co~prises the 8tep of
administering a composition comprising: a protein source;
a fat sourc~; a carbohydrate source; a zinc source
providing at least approximately ~50% of the USRDA of
zinc at 1,000 Rcal; a Vitamin C cource providin~ at least
approximately 500% of the U5RDA o~ Vitamin C at 1,000
~cal; a elenium ~ource proYiding at least approxi~ately
100 mcg o~ ~elenium at 1,000 X~al; a Vitamin A souxce
proviaing at least approxi~ately 145% o~ the USRDA o~
Vit~min A at 1,Oo~ Kcal; a beta-carotene source providing
at least approximately l.S mg of beta-caro~e"e at 1,000
~34~3
Kczl; and a source of thiamine providing at least
approximately 200% of the USRDA of thiamine at 1,000
Kc21.
In an embodiment, the elevated wound healing
reouirements is required in the patient because of:
trau~a; cancer; burns; pressure ulcers; surgery; or loss
of lean body mass greater than 15%.
An advantage of the present invention is that it
provides high protein to meet elevated wound healing
requirements.
Furthermore, an advantage of the prçsent invention
is that it provides 100% or more of the USRDA in 1,000
calories.
A further advantage of the present invention is that
it provides high levels of Vitauin C and zinc to ~upport
wound healing and provide for possible increased
requirements.
Still further, an advantage of the present invention
is that it is rich in beta-carotene t~ meet necessary
reguirements, prevent de~iciencies, and meet possible
requirements in long-term, tube fed patients.
A~ditionally, an advantage of the present invention
is that the nutrition co~position i~ rich in n-3 fatty
acids which may reduc~ i~mune suppression associated with
high n-6 fatty acid concentra$ions.
Further, an advantage of ~he present invention is
that it provide~ increased levels of thia~ine a~d other
B vita~ins to support eleYated requirements and ~reat
borderline deficienci~s that ~ay inter~ere with wound
heali~g.
~ oreover, an advantage of the pre~ent inven ion 1B
that it contains taurin~, carnitine, and ultra trace
.
2~3~3
-- 5 --
minerals to prevent deficiencies in long-term, tube fed
patients and support e7evated healing requirements~
~ dditional features and advantages of the present
invention are descri~ed in, and will be apparent from,
the detailed description of the presently pre~erred
embodiments.
DETAILED DESCRIPTION
OF THE PRESENTLY P~EFERRE~ EMBODIMENTS
The present invention provides nutritional product
for meeting the special metabolic needs o~ patient~ with
elevated healing requirements.
The present invention comprises at least
approximately 18% of the total calori~s as protein. In
a preferred embodiment, approximately 25% of the calories
are present as a protein. Pref~rably, the protein source
is casein. However, other protein sources can be used
including whey, total milk protein, and the like.
Elevated protein requirements have been identi~ied
in pa~ient populatisns such as pressur~ ulcer, serious
wounds, trauma, or where wasting has occurred. Inherent
to the metabolic reguirements of these conditions is an
incr~ased loss in nitro~en, increased requi~ement for
protein, or both.
In addition to requirements for high protein as a
percentage of total calories, increased nitrogen losses
and elevated requirements oi ~ertain vitamins, minerals,
and trace element~ ~ay occur. Guidelines for vitamins,
~inerals, and trace ele~ent~ in wound healing patients
do not exi~t due to the dir~iculty o~ per~orming well
controlled clinical research in these populations.
Pursuant to the present invention, the ~ormula o~
the pres~nt invention includes a high levsl v~ zinc.
- Preferably, at lea&t approximately 150~ of the USRDA of
~3~3
zi~c is provided in the composition per 1,000 Kcal. In
a preferred embodiment, 24-27 milligrams per 1,000
calories of zinc are provided (160 to 208% of the USRDA).
The increased zinc makes up for zinc losses and provides
increased zinc for tissue repair in a patient having
increased healing requirements.
Pursuant to the present invention, at least
approximately 500% of the USRDA of Vitamin C is provided
per 1,000 Kcal. In a preferred embodiment, 340
milligrams per 1,000 calories of Vitamin C is provided
(540% of USRDA). Vitamin C is believed to accelerated
the wound healing and granulation in patients with ~evere
wound healing requir~ments. Vitamin C wil-l support
increased reguirements/losses after surgery.
- The present invention also provides-- increased
amounts of selenium. Selenium deficiencies may develop
in patients havinq elevated wound healing requirements
despite selenium intakes within the range of no~mal
healthy adults ~106-146 micrograms per day). Pursuant
~o the pr~sent inven~ion, at least approximately 100
micrograms of selenium are provided in 1,000 calories of
formula per day. Althc~ugh a IJSRDA rPqui:remellt for
selenium does not exist, it is believed by some to be
around 50 ~cg a day for a normal healthy adult.
Although ~any commercially available ~nteral
~ormulations provide more than ad~uate ~uppli~s of
Vitamin A for healthy individuals, patients 6uffering
fro~ a variety o~ illness may have high~x requirement~.
Furtber, Vit~min A may be ~nobilized f~rom liver ~;~ores
3 0 more poorly due to lower synthesis of ~erum retinol
bindin~ protein~ Inde~d, retinol binding protein level5
decreases may be as~ociated with protein-energy
~alnutrition and zinc de~iciency.
~,7itamin A can stimulate the synthesis of connective
tissu~. Conversely, Vitamin A deiciency leads to
impai~ed collagen synthesis. Additionally, Vitamin A has
been shown to overcome the inhibitory ef~ects of
cortisone on the rate of gain in tensile strength in
early stages of healing. In this capacity, Vitamin A
maintains and restores the in~lammatory stimulus required
to generate healing factors for wound repair. The
present invention provides at least 145% of She USRDA per
1,000 ~cal of Vitamin A.
Nearly all, if not all, ~f the maj or curr~ntly
comm rcially available enteral formulas contain ar below
the a~ounts of carotenoids (beta-carotene) found in the
usual diets of normal healthy people. In ~a~, patients
on liguid formula diets as ~heir sole source of nutrition
for one week or more have been ~ound to have plasma
concentrations of carotenoids of only 8 to 18 percent as
compared to controls consuming a free choice diet. See,
Bowen et al, Hypocarotenemia in Patients Fed Enterally
with Commercial Liquid Diets, JPEN, 1988; 12(5):484-
489. Those on enteral formulas for more than 3 weeks
have ne51igible concentrations of any common serum
carotinoids.
To meet these reguirements, the present invention
provides at least 20 0 milligra~s of beta-carotene per
1,000 calori~s, Preferably, 2 milligrams o~ beta-
carotene per 1,000 calories ~re provided. This prevents
deficiencies and provide~ for pos~ible increased
requirements in the wound healing patient. The beta-
carotene levels allows pla~a concentra~ione ~o be
increased to near normal optimal levels of 500 mcg per
liter.
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Ihe present invention also provides increased
thiamine to meet requirements and treat marginal thiamine
deficiencies found în most geriatric patients~ Further,
the increased thiamine is desirable because water soluble
S vit æin requiremen~s may increase during healing. In an
embodiment, at least approximately 200~ of the USRDA ~or
thiamine is provided in 1,000 calories. In a presently
preferred embodiment, approximately 200% of the USRDA for
thiamine is provided per 1,000 calories of composition.
The present invention also provides at least
approximately 100% of the USRDA, at 1,000 Kcal, of
necessary trace elements molybdenum and chromium. In a
preferred embodiment, approximately ~40 mcg of chromium
is provided and approximately 200 mcg of molybdenum is
provided per 1,000 Kcal.
Additionally, at least approximately 150% of USRDA
at 1,000 Kcal of Vitamin E is pxovided. The fat soluble
vitamins have been associated with improved h~aling.
The present inven~ion provides a fa~ source. In a
preferred embodiment, the fat ~ource includes, as a
percent of the caloric distribution 0 to 30% MCTs. In
a presently preferred embodLment, approxima~ely 25% of
the calories of ~he fat ~ource ar~ provided as MCTs.
~ddi~ionally, the ~at source includes pre~erably a
ratio of n-6 to n-3 fatty acids of approximately 2:1 to
abou~ 10:1. Preferably, the ratio of n-6 to n-3 fatty
acids is approximately 2.5 to 1~ T~e ratio is preferably
achieved using canola oil. ~owever, other oils such a~,
for example, soy bean oil, olive oil, corn oil, marine
oil, or ~ixtures ~hereof, can be used.
~ he present i~vention can b~ used to trea~ elevated
wound heali~g require~ents~ As used herein, elevated
wound healing re~uirement~ can be caused by the following
2~3~3
conditions: trauma; burns; pressure ulcers; p~st
surgical wound care; cancer; and losses of lean body
masses of greater than 20%.
Typically, on average, approximately 2,000 Kcal of
composition will be given per day to a patient with
elevated wound healing requirements. Of cours~, some
patients with very high requirements may require
substantially more composition and some patients with
lower requirements, and/or weights, may require less
composition.
By way of example, and not limitation, examples of
the present invention will now be given:
Example of
Con~osition ofExample of
- UnitP r e s e n tC~osition . X USRDA
Hutrients(Per liter) _ventionith Fiber _ tPer liter~
Prote.in 9 62.5 62.5 140
Fat 9 3
HCT oil 9 8.4 (25%)8.4 (25X)
Canola oil 9 23.6 (69X)23.6 t69X)
Letithin g 2.0 ~6X) 2.0 (6X)
Ch~ 9 113 113
Dietary Fiber 9 0 14
Energy value Kcal 1000 1000
2 5 ~ater 9 .-845 836
Yit~nin AIU 7333* 7333~ 147
~(lnLludes 2 y or 3333 IU from beta-carotene)
Vit2lYin D IU 400 400 100
VitdDIin E JU 60 60 200
Vita~in l; rcg 80 80 *
Vit~in C n~ 340 340 567
Thi~ine (Bl) mg 3 3 200
Riboflavin (B2) mg 2.4 2.4 141
Hiacin mg 28 28 140
Vit2~in B6 mg 4 4 200
Folic Acid mcg 540 540 135
Pantothenic ~id mg 14 14 140
VitalDin B12 rlcg 8 8 133
f
20~3d~3
-- 10 --
B i~ . mcg 40~ 400 133
Ch^ 1-.e mg ~S0 450
TêL,~.^~ m9 IDO 100
L-C~ 11i9 100 100
C2~ OOO1000 1OO
Ph^s_~ s ~9 1000 1000 1OO
l~-nes~ mg 400 400 100
Ir~r. Ii~g IB 18 100
0 Zinc ng 24 24 160
Cop~ 2 2 100
Mansz.~se mg 4 4
lodiM! mcg 160 160 107
Sodiu3 D~ ~D0 500
Potassi~ mg 1560 1560
Chlorioe Irg1000 1000
Chrociu~ m~g 140 140
Hol~bde;~mcg 220 220
Seler~ cg 100 100
20 Osn~lzlity I~Osm/Kg290 300
Dietary fiber can be present as soy polysaccharide.
It should be understood that v rious changes and
modifications to the presently preferred e~bodiments
descrihed herein will be apparent to those skilled in the
art. Such changes and ~odifications can be made without
departing from the spirit and scope o~ the present
invention and without diminishing its attendant
advantages. It is therefore intended that such changes
and modifications be covered by the appended claims.
