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PEDIATRICS (ISSN 0031 4005). Copyright © 1983 by the
American Academy of Pediatrics.
Committee on Nutrition
PEDIATRICS Vol. 72 No. 3 September 1 983 359
Soy-Protein Formulas: Recommendations forUse in Infant Feeding
Many infant formulas are available as alterna-
� tives to breast-feeding. These formulas are neces-
� sary and valuable resources in the nutriture of
infants, but it is important to evaluate their use
and efficacy periodically. Soybean preparations
were suggested as a milk substitute by Hill and
Stuart’ in 1929.
Since then, the use of these products has ex-
panded appreciably, and they are used for an esti-
mated 10% to 15% of all formula-fed infants. This
increase in use has prompted examination of the
following critical issues about the indications for
use of soy-protein formulas in infants. (1) Are soy-
protein formulas an adequate nutritional substitute
for cow’s milk-based formulas in full-term infants?
(2) Is it appropriate to recommend soy-protein for-
0 mulas to provide a lactose-free formula, or are there
better alternatives? (3) Are soy-protein formulas
ever indicated for use in premature infants? (4)
What is the evidence for and against the use of soy-
protein formulas in the management of cow’s milk-
protein allergy? (5) What is the role of soy-protein
formulas in prophylaxis of allergic disease? (6)
What is the evidence for and against the use of soy-
protein formulas in the management of “colic”?
Examination of these issues will hopefully, pro-
vide a more clear-cut basis for decisions regarding
the use of soy-protein formulas and updated rec-
ommendations for the role of soy-protein formulas
in feeding human infants.
COMPOSITION OF SOY-PROTEIN FORMULAS
� Soy-protein formulas, although different in car-
� bohydrate and protein source, are similar in corn-
� position to cow’s milk-protein formulas following
� the American Academy of Pediatrics, Committee
� on Nutrition, 1976 recommendations for nutrient
� levels in infant formulas.2 Differences include a
� slightly higher protein level and slightly lower car-
� bohydrate content. The protein source is generally
(but not always) soy-protein isolate; the fat is a
blend of vegetable oils; and the source of carbohy-
drate is usually sucrose, corn syrup solids (hydro-
lyzed corn starch), or a mixture of both. Thus “soy”
formulas are called this because soy is used as a
protein source. The lactose-free characteristic of
these formulas also enhances their use in specific
situations.
The quality of a product depends to a consider-
able extent on its processing. The first infant for-
mulas containing soy protein used fat-free soy
flours; as a result, they were dark in color, had a
distasteful flavor, and, because of the soluble car-
bohydrates from the soybean, were the cause of
flatus and foul-smelling stools.3’4 The development
of more refined soy-protein isolate has made the
manufacture of higher quality, soy-based formulas
possible. Although the specific processing of soy
proteins is kept confidential by the manufacturers,
the primary objective is extraction of the major
protein fraction.5 Heat treatment of soy proteinreduces the activity of trypsin inhibitors and
hemagglutinins6 and enhances protein digestibility
and bioavailability of some minerals.7 For example,
although iron absorption appears to be inhibited in
soy products,8 absorption from soy-isolate formulas
has been shown to be similar to that from cow’s
milk protein formula.#{176} However, in the processing
of isolates, the formation of tightly bound protein-
phytic acid-mineral complexes may reduce the
availability of some minerals.’0 Zinc in soy also
appears to be less well absorbed; however, supple-
mental zinc absorption does not appear to be im-
paired.7”#{176} The amount of phytic acid in these for-
mulas and its effect on mineral and trace element
availability needs to be more clearly delineated.
Carnitine, which is required for the optimal oxida-
tion of fatty acids, is generally found in low concen-
trations in foods of plant origin as compared to
foods of animal origin. Therefore, soy-based for-
mulas contain minimal amounts of carnitine. How-
ever, there is insufficient evidence to conclude that
carnitine should be added to formulas on a routine
basis.”
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360 SOY-PROTEIN FORMULAS
Because soy-protein formula provides the sole
source of nutrition for many infants, the adequacy
of the amino acids provided by soy protein is im-
portant. Fomon et al’2 showed improved biologic
quality of soy-protein isolate with fortification of
the first limiting amino acid, methionine. Methio-
nine appears to limit nitrogen retention at deficient
levels of intake but not at requirement levels or
above, making supplementation unnecessary when
the intake of protein is adequate.’3 However, me-
thionine is now routinely added to all soy-protein
formulas manufactured in the United States.
USE IN FULL-TERM INFANTS
Normal growth and development in full-term
infants fed soy-protein formulas have been well
documented in numerous studies.’421 A recent re-
view of this topic by Fomon and Ziegler22 reported
growth and nitrogen balance studies in infants fed
soy-protein formula or cow’s milk-protein formula.
No significant differences were found between the
two groups of infants in either weight or length.
Furthermore, concentrations of serum urea nitro-
gen, total protein, and albumin did not differ sig-
nificantly between the infants consuming cow’s
milk-based formulas and those consuming soy-pro-
tein formulas. However, when expressed in terms
of weight gain per unit of energy intake, infants
receiving soy-protein formulas had slightly lower
rates of weight gain. Although this observation is
of some interest, available evidence suggests that
formulas using methionine-supplemented, soy-pro-
tein isolate promote normal growth and develop-
ment in full-term, healthy infants.
USE IN LACTOSE INTOLERANCE AND
GALACTOSEMIA
Soy-protein formulas are lactose-free and supply
carbohydrate from either sucrose or corn syrup
(hydrolyzed corn starch). Thus, when lactose elim-
ination is required for the management of primary
lactase deficiency or galactosemia, soy-protein for-
mula is the feeding of choice. In addition, secondary
lactose intolerance resulting from enteric infection
or other causes of mucosal damage can be managed
with soy-protein formula.2325 After the diarrhea
and the intestinal damage have been resolved, re-sumption of a cow’s milk-protein formula is appro-
priate (generally 2 weeks after cessation of the
diarrhea).
USE IN PREMATURE INFANTS
The first report of the result of feeding soy-
protein formula in premature infants was that of
Omans et al,26 who found considerably more varia-
bility in weight gain than with feedings of cow’s
milk formula. However, these studies were with soy
protein not supplemented with methionine. In an-
other comparative study of soy-protein and cow’s
milk-protein formulas in premature infants, Naud#{233}
et al,27 using a methionine-supplemented formula,
found reduced weight and length growth and sig-
nificantly lower serum albumin levels in infants fed
soy-protein formula. Shenai et al28 in a comparison
of cow’s milk-protein formula and soy-protein for-
mula (methionine supplemented), found normal
and equal growth in length and weight and similar
and normal serum albumin levels between the two
groups. The mean BUN values were significantly
greater and the nitrogen retention values were sig-
nificantly lower in the soy-protein fed group; how-
ever, the BUN values were in the normal range for
premature infants, and the nitrogen retention val-
ues were in the normal range of fetal nitrogen
accretion rates.
In all three of the feeding studies,2628 serum
phosphorus levels were significantly lower in the
groups fed soy-protein formula; and, in the two
studies in which serum alkaline phosphatase levels
were measured,27’28 serum phosphorus levels were
significantly elevated over levels found in the in-
fants fed cow’s milk-protein formula. Osteoporosis
and rickets recently were reported in sick, very low-
birth-weight infants. These infants, fed soy-protein
formulas for several months, have been found to
have this complication.293#{176} The low calcium con-
tent of soy-protein formulas (relative to the needs
of the rapidly growing, very low-birth-weight in-
fant) and all standard infant formulas and human
milk is a major cause. However, the hypophospha-
temia associated with the prolonged use of soy-
protein formulas in premature infants probably can
accelerate the development of hypophosphatemic
rickets. The reason for the hypophosphaternia is
not certain, but it may lie with the binding of some
of the soy milk phosphorus with phytate in the
formula, leading to its unavailability for intestional
absorption.
The use of soy-protein formula in premature
infant feeding was encouraged by the initial reports
of the efficacy of continuous nasojejunal feeds in
the feeding of very low-birth-weight infants. Soy-
protein formula was widely used for feeding by this
route because the formula osmolality was low, and
the lack of lactose seemed to confer an advantage
in feeding very� low-birth-weight infants who fre-
quently tolerated lactose loads poorly. In particular,
soy-protein formulas seemed to be associated with
a lower incidence of necrotizing enterocolitis(NEC). However, the effect on the development of
NEC probably is more the result of the rate at
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AMERICAN ACADEMY OF PEDIATRICS 361
which the formula is given and the rapidity of
feeding increases than the osmolality, type of pro-
tein, or lack of lactose in the formula. Moreover,0 there are now other commercial formulas that are
isosmolar with plasma, even in concentrations of
24 calories per ounce, and these formulas have
reduced lactose levels. The disadvantages of the
soy-protein formula for very low-birth-weight in-
fant feeding, as discussed here, indicate that these
formulas should not be used for prolonged feeding
of very low-bi���gi�ifants. Rather, they
should be used only for specific therapeutic mdi-
cations and for periods of not more than 3 to 4
weeks.
MANAGEMENT OF COW’S MILK ALLERGY
The question of soybean allergenicity aroused
interest in 1934 with the report of a patient sensi-
tive to inhaled soybean who lived and worked near
a soybean mill.3’ Five other persons working in the
mill had evidence of allergic disease. Subsequent
animal studies32’33 concluded that soybean was a
weak sensitizing protein and soy-protein formulas
were deemed nonallergenic and recommended for
use in managing cow’s milk-protein allergic in-
fants.3436 j� 1960, a series of case reports of gas-
trointestinal and “allergic” reactions to soy protein
began to appear.3744
0 Serious gastrointestinal reactions to soy proteinincluded severe vomiting, diarrhea, and weight
loss37; flat intestinal mucosa38; a series of four in-
fants with colitis and persistent diarrhea39; and
documented systemic allergic manifestations to di-
etary soy protein.4042 Additional reports43’44 of soy
protein intolerance, concomitant with cow’s milk-
protein intolerance, and positive intracutaneous
tests of soybean in allergic children who received
soy-protein formula in infancy,45 also were pub-
lished. Because cow’s milk-protein allergy fre-
quently leads to small bowel damage,46 including
villus atrophy, mucosal permeability to other pro-
teins can result in an increased systemic uptake
and immunologic response to these proteins. Fur-
thermore, at a time of clinical allergic response to
cow’s milk protein, the uptake of otherwise nonal-
lergenic proteins might result in a similar allergic
reaction to these proteins, thus broadening the
allergic response.47 Therefore, in infants and chil-
dren already showing clinical manifestations of a!-
lergic disease, a less antigenic formula is warranted
(ie, protein hydrolysate).
PROPHYLAXIS OF ALLERGIC DISEASE IN
NEWBORN INFANTS
The role of soy-based formulas in the prevention
of allergic disease in newborn infants remains con-
troversial. Theoretically, any protein is a potential
allergen, and examples of soy-protein allergy have
been cited. Two studies in infants with strong fam-
ily histories of allergy48’49 fed human, soy, or cow’s
milk-protein formula found no significant differ-
ence in the development of allergy from the type of
feeding. On the other hand, Taylor et a!5#{176}identified
allergy-prone infants, compared human milk and
elemental feeding with unrestricted conventional
dietary regimens for infants, and showed a signifi-
cant decrease in children exposed to a less antigenic
intake. Gruskay5’ found similar results in breast-
fed allergy-prone infants compared with allergy-
prone infants cow’s milk or soy-protein formula.
Two similar studies in healthy, full-term infants
with no genetic history of allergic disease have
different interpretations. Eastham et a!52 showed
lower antibody titers to subsequent cow’s milk pro-
tein or soy protein in infants fed casein hydrolysate
formula for the first three months of life compared
with findings in infants fed cow’s milk-protein or
soy-protein formula. This suggests that soy protein
is as antigenic as cow’s milk protein and indicates
intestinal mucosal barrier maturation as a factor in
the development of allergic disease. May et a153
recently found the feeding of soy-protein formula
from birth to 112 days did not lessen the antibody
response to cow’s milk-protein products fed subse-
quently.
At this time, evidence suggests that soy protein
may be less allergenic than heat-treated, cow’s milk
protein and is probably a better source of nutrition
in allergy-prone infants. However, whether or not
soy protein represents the optimum form of pro-
phylaxis is still controversial. The extent to which
early exposure to antigen affects the subsequent
development of allergic disease requires more so-
phisticated prospective studies to resolve the issue
objectively.
TREATMENT OF COLIC
Colic is a frequent symptom complex of abdomi-
nal pain and severe crying of presumed gastrointes-tinal etiology. A multitude of dietary factors (in-
cluding overfeeding, allergy, and carbohydrate in-
tolerance) have been implicated as possible
causes.54’55 However, only occasionally does achange in diet prevent further attacks, with symp-
toms in most infants resolving spontaneously, by 4
months of age. A recent study of Lothe et a156
compared the effects of cow’s milk-protein formula,
soy-protein formula, and protein hydrolysate for-
mula in the management ofcolic. They found symp-
toms to be unrelated to diet in 29% of the infants;
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362 SOY-PROTEIN FORMULAS
18% were symptom-free while receiving soy for-
mula; and 53% were unchanged or colic was worse
while receiving soy or cow’s milk-protein formula,
but the symptoms resolved when casein hydrolysate
was given. This raises the possibility that cow’s
milk is a precipitating factor in some infants with
colic and suggests that it may be most effectively
managed by the use of a casein hydrolysate. Any
conclusions are tentative at this time and more
controlled studies on this common problem are
needed.
CONCLUSIONS AND RECOMMENDATIONS
The use of soy-protein formula should be ap-
proached with thoughtful consideration of indica-
tions for use. Based on the information given here,
specific recommendations for the use of soy-protein
formula include: (1) in vegetarian families in which
animal protein formulas are not desired; (2) in the
management of galactosemia, primary lactase defi-
ciency, or the recovery phase of secondary lactose
intolerance, because these formulas are the least
expensive and most available formulas not contain-
ing lactose; and (3) in potentially allergic infants
(with a family history of atopy) who have not shown
clinical manifestations of allergy. However, these
infants should be monitored closely for allergy tosoy protein.
Instances when soy-protein formula should not
be used include: (1) for the routine feeding of pre-
mature and low-birth-weight infants; use should be
for limited periods, if at all; (2) in the dietary
management of documented clinical allergic reac-tion to cow’s milk protein and/or soy protein for-mula; and (3) in the routine management of colic.
ACKNOWLEDGMENT
The Committee wishes to thank Kristy M. Hendricks,
RD, MS, for assistance in the preparation of this paper.
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Alvin M. Mauer, MD, Chair
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Frederick Holmes, MD
John W. Reynolds, MD
Robert M. Suskind, MD
W. Allan Walker, MDCalvin W. Woodruff, MD
AAP Section Liaison
Stanley Hellerstein, MD
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1983;72;359Pediatrics Soy-Protein Formulas: Recommendations for Use in Infant Feeding
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