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.

REFERENCES

COMMITTEE ON NUTRITION, 1982-1983

Alvin M. Mauer, MD, Chair

Harry S. Dweck, MD

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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