Soy-Based Infant Formulas: A Review of Developmental and Nutritional Considerations (2025)

Soy-based formulae and infant growth and development: a review

The Journal of nutrition, 2002

Soy-based infant formulae, initially developed for infants who were lactose intolerant or allergic to cow's milk-based formulae, now account for >25% of the infant formulae sold in the United States. Formulations have changed over the years to improve digestibility, the stability and availability of minerals, and protein quality. Recent concerns have been raised regarding the phytoestrogenic isoflavone content of soy-based formulae. A systematic review of the literature was conducted to evaluate various measures of infant health and development in clinical studies comparing modern soy-based formulae with other diets and to document areas in which further research seems warranted. Results suggest that modern soy-based formulae support normal growth and nutritional status in healthy term infants in y 1 of life. However, there are very limited data on sexual and reproductive development or outcomes such as immune function, visual acuity/cognitive development and thyroid function...

Exposure to Soy-Based Formula in Infancy and Endocrinological and Reproductive Outcomes in Young Adulthood

JAMA, 2001

Context A large body of evidence documents the role of phytoestrogens in influencing hormone-dependent states. Infants fed soy formula receive high levels of phytoestrogens, in the form of soy isoflavones, during a stage of development at which permanent effects are theoretically possible. However, a paucity of data exists on the long-term effects of infant soy formulas.

Soy infant formula: is it that bad?

Acta Paediatrica, 2011

The objective of this study is to review the indications of soy infant formula (SIF). Structured review of publications is made available through standard search engines (Pubmed,…). The medical indications for SIF are limited to galactosaemia and hereditary lactase deficiency. In the treatment of cow's milk allergy, SIF is used for economic reasons, as extensive hydrolysates are expensive. SIF is dissuaded mainly because of its phytooestrogen content. Isoflavone serum levels are much higher in SIF-fed infants than in breastfed or cow milk formula-fed infants. Administration of pure isoflavones to animals causes decreased fertility, but clinically relevant adverse effects of SIF in infants are not reported.

NTP-CERHR expert panel report on the developmental toxicity of soy infant formula

Birth Defects Research Part B: Developmental and Reproductive Toxicology, 2011

Bone mineral content of infants fed soy-based formula

The Journal of Pediatrics, 1988

Safety of soya-based infant formulas in children

British Journal of Nutrition, 2014

Soy-Based Infant Formula Supplemented with DHA and ARA Supports Growth and Increases Circulating Levels of these Fatty Acids in Infants

Lipids, 2008

Healthy term infants (n = 244) were random ized to receive: (I) control, soy-based formula without supplementation or (2) docosahexaenoic acid-arachidonic acid (DHA + ARA), soy-based formula supplemented with at least 17 mg DHAIIOO kcal (from algal oil) and 34 mg ARAIlOO kcal (from oil) in a double-blind, parallel group trial to evaluate benefits, and growth from 14 to 120 days of age. Anthropometric measurements were taken at 14, 30, 60, 90, and 120 days of age and 24-h dietary and tolerance recall were recorded at 30, 60, 90, and 120 days of age. Adverse events were recorded throughout the study. Blood samples were drawn from subsets of 25 infants in eaeh group. Capillary column gas chromatography was used to analyze the of fatty acids in red blood cell (RBC) lipids and plasma phospholipids. Compared with the control group, pereent ages of fatty acids such as DHA and ARA in total RBC and plasma phospholipids were significantly higher in infants in the DHA + ARA group at 120 days of age (P 0.001).

Safety of Soy-Based Infant Formulas Containing Isoflavones: The Clinical Evidence

The Journal of Nutrition

Soy protein has been used in infant feeding in the West for nearly 100 y. Soy protein infant formulas have evolved in this interval to become safe and effective alternatives for infants whose nutritional needs are not met with human milk or formulas based on cow's milk. Modern soy formulas meet all nutritional requirements and safety standards of the Infant Formula Act of 1980. They are commonly used in infants with immunoglobulin E-mediated cow's milk allergy (at least 86% effective), lactose intolerance, galactosemia, and as a vegetarian human milk substitute. Largely as a result of research in animal models, concerns have been voiced regarding isoflavones in soy infant formulas in relation to nutritional adequacy, sexual development, neurobehavioral development, immune function, and thyroid disease. We discuss the available clinical evidence regarding each of these issues. Available evidence from adult human and infant populations indicates that dietary isoflavones in soy infant formulas do not adversely affect human growth, development, or reproduction.

soy for infants children adolescents

Soy Protein-Based Infant Formulas with Supplemental Fructooligosaccharides: Gastrointestinal Tolerance and Hydration Status in Newborn Infants

Nutrients, 2015

Unlike milk-based infant formulas, soy-based infant formulas containing supplemental fructooligosaccharides (FOS) have not been clinically evaluated. A randomized, double-blind, 28 day parallel feeding trial compared gastrointestinal (GI) tolerance and hydration in healthy term newborn infants fed either a commercialized soy formula (with history of safe use) containing sucrose as 20% of total carbohydrate, no supplemental short-chain FOS (scFOS) and no mixed carotenoids (lutein, lycopene, beta-carotene) as a control (CF, n = 62 infants) or one of two experimental soy-based formulas, EF1 (n = 64) and EF2 (n = 62) containing scFOS (2.5 g/L) and mixed carotenoids. EF1 differed from EF2 by containing sucrose. Results indicated no significant study group differences (p > 0.05) in study completion rates (CF = 81, EF1 = 86, & EF2 = 87%), growth, mean rank stool consistency, stool frequency, formula intake, spit-up/vomit, and safety measures (urine specific gravity, USG; hydration status and adverse events). Mean USGs for study groups were normal (<1.03). The EF1 > CF group in percent yellow stools (p < 0.01 at age 14 days). In conclusion, the study suggested that term infants fed soy-based formulas supplemented with scFOS and mixed carotenoids, with or without sucrose in the 1st 35 days of infancy demonstrated good tolerance and hydration comparable to the control soy-based formula with history of safe use.

Soy Protein Infant Formulae and Follow-On Formulae

Journal of Pediatric Gastroenterology and Nutrition, 2006

This comment by the European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) Committee on Nutrition summarizes available information on the composition and use of soy protein formulae as substitutes for breastfeeding and cows_ milk protein formulae as well as on their suitability and safety for supporting adequate growth and development in infants. Soy is a source of protein that is inferior to cows_ milk, with a lower digestibility and bioavailability as well as a lower methionine content. For soy protein infant formulae, only protein isolates can be used, and minimum protein content required in the current European Union legislation is higher than that of cows_ milk protein infant formulae (2.25 g/100 kcal vs. 1.8 g/100 kcal). Soy protein formulae can be used for feeding term infants, but they have no nutritional advantage over cows_ milk protein formulae and contain high concentrations of phytate, aluminum, and phytoestrogens (isofla-vones), which might have untoward effects. There are no data to support the use of soy protein formulae in preterm infants. Indications for soy protein formulae include severe persistent lactose intolerance, galactosemia, and ethical considerations (e.g., vegan concepts). Soy protein formulae have no role in the prevention of allergic diseases and should not be used in infants with food allergy during the first 6 months of life. If soy protein formulae are considered for therapeutic use in food allergy after the age of 6 months because of their lower cost and better acceptance, tolerance to soy protein should first be established by clinical challenge. There is no evidence supporting the use of soy protein formulae for the prevention or management of infantile colic, regurgitation, or prolonged crying. JPGN 42:352Y361, 2006. Key Words: soyVinfant formulaVfollowon formulaVfood allergyVphytoestrogens.

Soy allergy following early soy feeding in neonates

The Israel Medical Association journal : IMAJ, 2010

B ACKGROUND:Feeding neonates with humanized milk formula in maternity hospitals may increase the prevalence of milk allergy in infants. However, prospective studies of the possible allergenic effect of very early soy-based formula feeding are lacking. To assess the prevalence of soy allergy in infants fed soy-based formula in the first 3 days of life. The study group included 982 healthy full-term infants born within a 7 month period at a hospital that routinely uses soy-based formula to supplement breastfeeding. In-hospital feeding was recorded and the parents were interviewed once monthly over the next 6 months regarding feeding practices and clinical symptoms suggesting soy allergy in the infant. Ninety-nine percent of the infants received soy-based formula supplement in hospital, and 33%-42% at home. No cases of immediate allergic reaction to soy or soy-induced enterocolitis were reported. The use of soy-based formula in the early neonatal period does not apparently increase the...

Widespread Use of Soy-Based Formula Without Clinical Indications

Journal of Pediatric Gastroenterology &amp; Nutrition, 2005

Objectives: In view of reports of the growing popularity of soybased formula for infants, we examined soy consumption and its possible overuse during early infancy in central Israel. Methods: Mothers of 1803 infants aged 2, 4, 6 and 12 months attending well-baby clinics participated in a telephone survey covering background data, rate, duration, and pattern of soybased formula use and the reasons for its initiation. The reasons were grouped into those based on the recommendations of the medical personnel and those based on mothers' initiative, and evaluated according to infants' age at soy-based formula initiation (0 to 1, 2 to 4 and 5 to 12 months). The symptoms that prompted soy-based formula use were assessed quantitatively. Results: The rate of soy-based formula use was 10.4% at 2 months and 31.5% at 12 months (P , 0.001); 70.6% 6 2.7% of the infants were given soy for .6 months. Regardless of infants' age, the role of the mothers in the decision to use soy-based formula was greater than that of the medical personnel, and increased significantly with age (x 2 for trend = 0.018). A suspicion of cow's milk allergy was responsible for only 10.9% (7/64) of all soy initiations in infants aged 5 to 12 months. In all ages, occasional symptoms, mainly diarrhea (33.3%) and colic (19.8%), were the leading cause for recommending soybased formula by medical personnel, whereas the personal preference without clinical justification was the leading cause among mothers. Conclusions: The use of soy-based formula in central Israel is extensive and continues for long periods, with rates far beyond clinical indications. Mothers play a greater role than medical personnel in the decision to initiate soy-based formula. JPGN 41:660-666, 2005.

Soy formula for prevention of allergy and food intolerance in infants

Cochrane Database of Systematic Reviews, 2006

Bock 1990 Bock SA, Atkins FM. Patterns of food hypersensitivity during sixteen years of double-blind, placebo-controlled food challenges.

Soy-based formulas and phyto-oestrogens: a safety profile

Acta Paediatrica, 2007

Miniello VL, Moro GE, Tarantino M, Natile M, Granieri L, Armenio L. Soy-based formulas and phyto-oestrogens: a safety profile. Acta Paediatr 2003; Suppl 441: 93-100. Stockholm. ISSN 0803-5253

A longitudinal study of estrogen-responsive tissues and hormone concentrations in infants fed soy formula

The Journal of clinical endocrinology and metabolism, 2018

Chemicals with hormone-like activity, such as estrogenic isoflavones, may perturb human development. Infants exclusively fed soy-based formula are highly exposed to isoflavones, but their physiologic responses remain uncharacterized. Here, we compare estrogen-responsive postnatal development in infants exclusively fed soy formula, cow-milk formula and breast milk. We enrolled 410 infants born in Philadelphia area hospitals, 2010-2013; 283 infants were exclusively fed soy formula (n=102), cow-milk formula (n=111), or breast milk (n=70) throughout the study (birth to 28 [boys] or 36 [girls] weeks). We repeatedly measured maturation index (MI) in vaginal and urethral epithelial cells using standard cytological methods, uterine volume and breast-bud diameter using ultrasound, serum estradiol and, in girls, follicle-stimulating hormone. We estimated MI, organ-growth and hormone trajectories by diet using mixed-effects regression splines. Maternal demographics did not differ between cow-m...

Critics on Policy of Soy-Based Infant Formula in Indonesia: Compared to Australian and New Zealand Food Standards

GHMJ (Global Health Management Journal)

Background: World Health Organiza on (WHO) recommends breast milk as sole and the most complete infant food during the first 6 months. However, in certain circumstances, when breas eeding is not possible, not de- sired or not advised, infant formulas like those are made of soy can be given to newborns. However, the safety of long-term use soy-based formula has been argued due to the possible adverse effects of phytoestrogen, phytates and aluminum in human body as well as the consequences of agrochemicals residue. Therefore, those problems should be taken into account while developing, reviewing or amending policy of infant formulas. This ar cle re- views the adequacy of soy-based infant formula policy in Indonesia to an cipate issues in SIF consump on. Methods: Australian and New Zealand Food Standards Code was used to compared to the decree of Indonesian NADFC. The results were described narra vely and analyzed from the perspec ve of the author. Results: Accordingly, only small asp...

Association between parental self-reported knowledge on soy and phytoestrogen and their children's intake of soy-based infant formulae—a cross-sectional study of Israeli parents

International Journal of Public Health, 2020

Objectives Though natural phytoestrogen (PE) is a major factor in health authorities' considerations regarding soy-based infant formula (SBIF), missing their concentrations may interfere with parents' informed decision. Methods We performed an Internet survey investigating soy-related knowledge of parents. We built multiple logistic regression models adjusted for personal covariates for the association between parental knowledge on PE and children intake of SBIF and checked the effect of having children B 2 years old on this association. Results We enrolled 304 parents, 48.3% men, mean age 33.8 (standard deviation, SD 4.9), mostly with higher education. Of them, 76% had children under two years of age. Mean parental knowledge on PE was 9.83 (SD 3.28) from 20 possible points. Parental knowledge on PE reduced children's intake of SBIF (odds ratio, OR = 0.85 [95% confidence interval 0.70; 1.02]). Stronger inverse association was found for parents with children B 2 comparing with those with older children (OR = 0.85 [0.67; 1.09] and OR = 0.68 [0.39; 1.18], respectively), although these differences were not statistically significant. Conclusions Adding PE content to information on SBIF may support informed decision. Keywords Phytoestrogens Á Reproductive development and health Á Soy-based infant formulae Á Parental knowledge Á Consumption of soy products This article is part of the special issue ''Market-driven forces and Public Health.''

Soy- and Rice-Based Formula and Infant Allergic to Cow's Milk

Endocrine‚ Metabolic &amp; Immune Disorders-Drug Targets, 2014

Soy milk formula has limited medical indications for infants feeding, although in several parts of the world it has been used as a source of nutrition in a large number of children. It used to be the main alternative feeding for infants allergic to cow's milk who did not breastfeed before the introduction of extensively hydrolyzed formulas. Although there is a debate, the fact that some children are allergic to soy or some children with cow's milk allergy can present with concomitant soy allergy, restricted the use of soy formulas for treatment of infants allergic to cow's milk. Other grainbased formulas like the rice-based ones are promising in infants with cow's milk allergy. Grain-based formulas could be an alternative and cheaper way of nutrition for infants allergic to cow's milk than extensively hydrolyzed formulas. Further large scale longitudinal clinical studies are required to clarify the safety of soy and other grain-based formulas for treatment of cow's milk allergy.

Compared with Feeding Infants Breast Milk or Cow-Milk Formula, Soy Formula Feeding Does Not Affect Subsequent Reproductive Organ Size at 5 Years of Age

The Journal of nutrition, 2015

Literature reports suggest that phytochemicals, such as isoflavones found in soybeans, impair reproductive function in animals and raise the possibility that consuming soy infant formula could alter hormonally sensitive organ development in children. This study compared reproductive organs volumes and structural characteristics in children at age 5 y who were enrolled in the Beginnings study long-term cohort. Breast bud, uterus, ovaries, prostate, and testes volumes and characteristics were assessed by ultrasonography in 101 children (50 boys and 51 girls) aged 5 y who were breastfed (n = 35) or fed cow-milk formula (n = 32) or soy formula (n = 34) as infants. Analyses were adjusted for race, gestational age, and birth weight. Among girls, no significant differences were found in breast bud, ovarian, or uterine volumes; counts of ovaries with cysts; ovarian cysts numbers; ovarian cyst size; and uterine shape between the diet groups. Among boys, no significant differences were found ...