Pregnancy support- Warnings

Soy Infant Formula - updated: 03 November 2008

Aluminum and bone disorders: with specific reference to aluminum contamination of infant nutrients

J Am Coll Nutr. 1988 Jun;7(3):199-214

Koo WW, Kaplan LA.

Aluminum (Al) impairment of bone matrix formation and mineralization may be mediated by its direct effect on bone cells or indirectly by its effect on parathyroid hormone and calcium metabolism. Its toxic effects are proportional to tissue Al load. Al contamination of nutrients depends on the amount of Al present naturally in chemicals or from the manufacturing process. Intravenous calcium, phosphorus, and albumin solutions have high Al (greater than 500 micrograms/L), whereas crystalline amino acid, sterile water, and dextrose water have low Al (less than 50 micrograms/L) content. Enteral nutrients including human and whole cow milk have low Al, whereas highly processed infant formulas with multiple additives, such as soy formula, preterm infant formula, and formulas for specific disorders are heavily contaminated with Al. Healthy adults are in zero balance for Al. The gastrointestinal tract excludes greater than 95% of dietary Al, and kidney is the dominant organ for Al excretion. However, even with normal renal function, only 30-60% of an Al load from parenteral nutrition is excreted in the urine, resulting in tissue accumulation of Al. The risk for Al toxicity is greatest in infants with chronic renal insufficiency, recipients of long term parenteral nutrition, i.e., no gut barrier to Al loading, and preterm infants with low Al binding capacity. The rapid growth of the infant would theoretically potentiate Al toxicity in all infants, although the critical level of Al loading causing bone disorders is not known. To minimize tissue burden, Al content of infant nutrients should be similar to "background" levels, i.e., similar to whole milk (less than 50 micrograms/L).

Publication Types:

• Review

Aluminum contamination of infant formulas

JPEN J Parenter Enteral Nutr. 1988 Mar-Apr;12(2):170-3

Koo WW, Kaplan LA, Krug-Wispe SK.

This study aims to determine the extent of aluminum (Al) contamination in whole milk, milk formulas, and other nutrient products commonly used for infants. Similar products from different manufacturers and different lots were measured for Al using electrothermal atomic absorption technique. Aluminum measurements were made directly from the samples or after reconstitution or dilution with Al-free water. Aluminum content was lowest (less than 50 micrograms/liter) in human milk, whole cow milk, and products that appear to require minimal manufacture processing and have few additives such as skim milk, cow milk with 2% fat, bottled glucose water, and sterile water. Highest Al levels (up to 2346 micrograms/liter) were found in highly processed and modified formulas including soy formula, preterm infant formula, and formulas for specific metabolic disorders. Aluminum content of humanized cow milk formula and bottled glucose-electrolyte solution were between the two ranges and usually less than 400 micrograms/liter. There were no significant differences in Al content of similar products from different manufacturers. Liquid formula stored in glass bottles has highest Al content compared to that stored in steel cans or powder preparation of the same product (p less than 0.05). Thus there are marked differences in Al loading depending on the type of formula, whether it is a powder or liquid preparation and the type of storage container. We speculate that raw materials such as soybean, additives such as calcium and phosphorus, manufacturing processes and storage containers are potential sources of contamination of infant formulas.

Publication Types:

• Review

Artificial baby milks: how safe is soya?

This article first appeared in RCM Midwives Journal. Copyright RCM. Not to be reproduced without first contacting Baby Milk Action.

Tessa Martyn

UK toxicology experts have recently confirmed concerns over the potential health risks of soyabased artificial baby milks. This may come as news to many – especially health professionals who freely recommend it, or parents who can buy it off the shelves (no questions asked) believing it to be a healthy option. Soya is generally viewed as a healthy food, and for adults there are some reported health benefits. However, human infants were ‘designed’ to drink human milk, and soya-based milk products are a far cry from breast milk.

Breast development in the first 2 years of life: an association with soy-based infant formulas

J Pediatr Gastroenterol Nutr. 2008 Feb;46(2):191-5

OBJECTIVE: To evaluate the estrogenic effect of soy-based formulas in female infants. These formulas contain significant amounts of phytoestrogens, compounds with structural similarity to estradiol. PATIENTS AND METHODS: A cross-sectional study consisting of 694 female infants ages 3 to 24 months that consecutively attended 10 general pediatric clinics, none of them having been referred for breast development. The presence of breast buds served as a marker for the endocrine effect of soy-derived phytoestrogens. RESULTS: Of the participants, 92 had consumed soy formulas for more than 3 months. Breast tissue was more prevalent in the second year of life in infants fed soy-based formula vs those that were breast-fed and those fed dairy-based formula (22.0% vs 10.3%; P = 0.02) with an odds ratio of 2.45 (95% confidence interval 1.11-5.39). No differences in breast bud prevalence were observed during the first year of life. Unlike infants on dairy-based formulas and breast-feeding, infants fed a soy-based formula did not demonstrate a decline in the prevalence of breast during the second year of life. CONCLUSIONS: We suggest that phytoestrogens impose a preserving effect on breast tissue that is evolved in early infancy, leading eventually to a slower waning of infantile breast tissue.

Publication Types:

• cross-sectional study

Soy infant formula and phytoestrogens

J Paediatr Child Health. 2003 Aug;39(6):401-5

Tuohy PG.

Soy infant formula contains high levels of the isoflavones, genistein and daidzein, which are commonly referred to as phytoestrogens. These are non-steroidal chemicals with structural similarities to estrogen. Infants consuming soy formula have high levels of circulating isoflavones. These are an order of magnitude greater than the levels of isoflavones which have been shown to produce physiological effects in adult women consuming a high soy diet. There is conflicting evidence about the risks and benefits of soy phytoestrogens, with research presenting a contradictory picture. Some reviewers suggest that early exposure to soy may prevent cancer and heart disease. However, there is very little research on the effects of consumption of soy phytoestrogens by human neonates. Against this generally positive view there is an increasing number of recent reports that suggest that in experimental animals, phytoestrogens have adverse effects with respect to carcinogenesis, reproductive function, immune function, and thyroid disease. Despite the absence of adequate scientific research that quantifies the level of risk to infants, most would argue for a precautionary approach to be taken in situations where there are potential developmental effects from the consumption of pharmacologically active compounds in infancy and childhood.

Publication Types:

• Review

Urinary isoflavone excretion as a compliance measure in a soy intervention among young girls: a pilot study

Eur J Clin Nutr. 2005 Mar;59(3):369-75

Maskarinec G, Oshiro C, Morimoto Y, Hebshi S, Novotny R, Franke AA.

OBJECTIVE: To investigate the compliance of young girls with a soy intervention. DESIGN: An 8-week dietary intervention and urine sample collection. SETTING: Free-living girls. SUBJECTS: A convenience sample of 8- to 14-y-old girls (20 started and 17 finished the study) recruited through flyers distributed to staff members and previous study participants. INTERVENTION: The girls consumed one daily serving of soymilk, soy nuts, or tofu, completed 3-day food records, kept daily soy intake logs, and collected weekly urine samples. MAIN OUTCOME MEASURES: Compliance with the intervention was evaluated by daily soy intake logs, 3-day food records analyzed by the center's Food Composition and Food Groups Servings Databases, and weekly urinary isoflavone excretion using high-pressure liquid chromatography. The statistical analysis included paired t-tests, analysis of variance, and Spearman's rank-order correlation coefficients. RESULTS: Daily soy intake logs indicated a mean intake of 6.28 servings out of a maximum of 7.0 servings per week. The food records revealed a six-fold increase in isoflavone intake during the study period (P<0.01) which was confirmed by an increase in urinary isoflavone excretion of similar magnitude (23.3-142.1 nmol/mg creatinine, P=0.02). CONCLUSIONS: This study demonstrated the ability of young girls to consume one daily soy serving and the usefulness of urinary isoflavones as a primary compliance measure. The high urinary isoflavone excretion levels detected in girls as compared to adult women suggest less intestinal degradation and/or greater absorption of isoflavones in nonadult populations. This finding requires further investigations into the pharmacokinetics of isoflavones.

Publication Types:

• 8-week dietary intervention

Dietary oestrogens and male fertility potential

Hum Fertil (Camb). 2005 Sep;8(3):197-207

West MC, Anderson L, McClure N, Lewis SE.

Reports of increased incidences of male reproductive abnormalities and falling sperm counts have prompted interest into the nature of these threats to global fertility. Xenoestrogens have been flagged as major culprits but to date, little is known about the effects of dietary phytoestrogens on male reproductive health. These non-steroidal oestrogens of plant origin are potent endocrine disruptors that modulate normal physiological functions. Phytoestrogens have become a major component in the typical Western fast food diet over the last few decades. Soy formula milk is another common source of phytoestrogens, now used increasingly as an alternative to breast or cow's milk for infants with allergies. This use is of particular concern since the most vulnerable periods for oestrogenic insult are thought to be the pre- and neonatal periods when irreversible damage can be inflicted on the developing germinal epithelium. Studies into the safety of phytoestrogens are urgently needed either to allay fears or increase awareness of the effects of our modern diet on future fertility.

Phytoestrogens: potential endocrine disruptors in males

Toxicol Ind Health. 1998 Jan-Apr;14(1-2):223-37

Santti R, Mäkelä S, Strauss L, Korkman J, Kostian ML

Exposure to diethylstilbestrol (DES) induces persistent structural and functional alterations in the developing reproductive tract of males. It is possible that xenoestrogens other than DES alter sexual differentiation in males and account for the increasing incidence of developmental disorders of the reproductive tract in men and wild animals. Phytoestrogens (coumestans, isoflavonoids, flavonoids, and lignans) present in numerous edible plants are quantitatively the most important environmental estrogens when their hormonal potency is assessed in vitro. They exert their estrogenic activity by interacting with estrogen receptors (ERs) in vitro. They may also act as antiestrogens by competing for the binding sites of estrogen receptors or the active site of the estrogen biosynthesizing and metabolizing enzymes, such as aromatase and estrogen-specific 17 beta-hydroxysteroid oxidoreductase (type 1). In theory, phytoestrogens and structurally related compounds could harm the reproductive health of males also by acting as antiestrogens. There are very little data on effects of phytoestrogens in males. Estrogenic effects in wildlife have been described but the evidence for the role of phytoestrogens is indirect and seen under conditions of excessive exposure. In doses comparable to the daily intake from soybased feed, isoflavonoids such as genistein were estrogen agonists in the prostate of adult laboratory rodents. When given neonatally, no persistent effects were observed. In contrast, the central nervous system (CNS)-gonadal axis and the male sexual behavior of the rat appear to be sensitive to phytoestrogens during development. The changes were similar but not identical to those seen after neonatal treatment with DES, but higher doses of phytoestrogens were needed.

Publication Types:

• Review

A maternal vegetarian diet in pregnancy is associated with hypospadias. The ALSPAC Study Team. Avon Longitudinal Study of Pregnancy and Childhood

BJU Int. 2000 Jan;85(1):107-13

North K, Golding J.

OBJECTIVE: To investigate the possible role of the maternal diet, particularly vegetarianism and consumption of phytoestrogens, in the origin of hypospadias, which is reported to be increasing in prevalence. SUBJECTS AND METHODS: Detailed information was obtained prospectively from mothers, including previous obstetric history, lifestyle and dietary practices, using structured self-completed questionnaires during pregnancy. Previously recognized associations with environmental and parental factors were examined, focusing particularly on the hypothesized hormonal link. Multivariate logistic regression was used to identify independent associations. RESULTS: Of 7928 boys born to mothers taking part in the Avon Longitudinal Study of Pregnancy and Childhood, 51 hypospadias cases were identified. There were no significant differences in the proportion of hypospadias cases among mothers who smoked, consumed alcohol or for any aspect of their previous reproductive history (including the number of previous pregnancies, number of miscarriages, use of the contraceptive pill, time to conception and age at menarche). Significant differences were detected for some aspects of the maternal diet, i.e. vegetarianism and iron supplementation in the first half of pregnancy. Mothers who were vegetarian in pregnancy had an adjusted odds ratio (OR) of 4.99 (95% confidence interval, CI, 2.10-11.88) of giving birth to a boy with hypospadias, compared with omnivores who did not supplement their diet with iron. Omnivores who supplemented their diet with iron had an adjusted OR of 2.07 (95% CI, 1.00-4.32). The only other statistically significant association for hypospadias was with influenza in the first 3 months of pregnancy (adjusted OR 3.19, 95% CI 1.50-6.78). CONCLUSION: As vegetarians have a greater exposure to phytoestrogens than do omnivores, these results support the possibility that phytoestrogens have a deleterious effect on the developing male reproductive system.

Publication Types:

• Avon Longitudinal Study of Pregnancy and Childhood

Publication Types:

• Review