Safety of soya-based infant formulas in children.

Soya-based infant formulas (SIF) containing soya flour were introduced almost 100 years ago. Modern soya formulas are used in allergy/intolerance to cows' milk-based formulas (CMF), post-infectious diarrhoea, lactose intolerance and galactosaemia, as a vegan human milk (HM) substitute, etc. The safety of SIF is still debated. In the present study, we reviewed the safety of SIF in relation to anthropometric growth, bone health (bone mineral content), immunity, cognition, and reproductive and endocrine functions. The present review includes cross-sectional, case-control, cohort studies or clinical trials that were carried out in children fed SIF compared with those fed other types of infant formulas and that measured safety. The databases that were searched included PubMed (1909 to July 2013), Embase (1988 to May 2013), LILACS (1990 to May 2011), ARTEMISA (13th edition, December 2012), Cochrane controlled trials register, Bandolier and DARE using the Cochrane methodology. Wherever possible, a meta-analysis was carried out. We found that the anthropometric patterns of children fed SIF were similar to those of children fed CMF or HM. Despite the high levels of phytates and aluminium in SIF, Hb, serum protein, Zn and Ca concentrations and bone mineral content were found to be similar to those of children fed CMF or HM. We also found the levels of genistein and daidzein to be higher in children fed SIF; however, we did not find strong evidence of a negative effect on reproductive and endocrine functions. Immune measurements and neurocognitive parameters were similar in all the feeding groups. In conclusion, modern SIF are evidence-based safety options to feed children requiring them. The patterns of growth, bone health and metabolic, reproductive, endocrine, immune and neurological functions are similar to those observed in children fed CMF or HM.

Safety of a dual potential prebiotic system from Mexican agave "Metlin® and Metlos®", incorporated to an infant formula for term newborn babies: a randomized controlled trial.

RATIONALE: Infant formulae are being supplemented with probiotics, prebiotics, or symbiotic despite uncertainties regarding their efficacy. Mexican agave is an interesting source of fructans with particular features and with potential prebiotic effects. MATERIAL AND METHODS: RCT in 600 healthy term babies (20 ± 7 days), allocated to receive standard infant formula (control) or infant formula added with a dual prebiotic system "Metlin® and Metlos®", from Mexican agave. Primary outcomes include stools frequency, stools consistency, gastrointestinal intolerance (frequency of abdominal distension, flatulency, regurgitations, vomiting). Secondary outcomes include changes on weight and height along the study and frequency of dermatologic problems (eczema). RESULTS: In 66,120 days of total follow-up, there were no differences on the frequency of stools passage (Human Milk: 3.8 ± 2.4 evacuations per day; Pro + Metlin + Metlos 3.6 ± 2.0; Pro + Metlin 3.6 ± 2; only Pro 3.4 ± 2.3¸ only formula 3.4 ± 2.0; p NS). Consistency of stools was similar between human milk and prebiotics supplemented groups. Also the frequency of gastrointestinal symptoms was significantly low between these groups. CONCLUSIONS: Fructans derivate from agave and added to infant formula are safe and well tolerated by Mexican healthy term babies.