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Soy protein-based infant formulas with supplemental fructooligosaccharides: gastrointestinal tolerance and hydration status in newborn infants.

ABSTRACT: 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.

SUBMITTER: Lasekan J

PROVIDER: S-EPMC4425187 | biostudies-literature | 2015 Apr

REPOSITORIES: biostudies-literature

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Soy protein-based infant formulas with supplemental fructooligosaccharides: gastrointestinal tolerance and hydration status in newborn infants.

Lasekan John J Baggs Geraldine G Acosta Sonja S Mackey Amy A

Nutrients 20150422 4

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- ...[more]

PMID: 25912040

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Project description:Formula-fed (FF) infants often have harder stools and higher stool concentrations of fatty acid soaps compared to breastfed infants. Feeding high sn-2 palmitate or the prebiotic oligofructose (OF) may soften stools, reduce stool soaps, and decrease fecal calcium loss.We investigated the effect of high sn-2 palmitate alone and in combination with OF on stool palmitate soap, total soap and calcium concentrations, stool consistency, gastrointestinal (GI) tolerance, anthropometrics, and hydration in FF infants. This double-blind trial randomized 165 healthy term infants 25-45 days old to receive Control formula (n?=?54), formula containing high sn-2 palmitate (sn-2; n?=?56), or formula containing high sn-2 palmitate plus 3 g/L OF (sn-2+OF; n?=?55). A non-randomized human milk (HM)-fed group was also included (n?=?55). The primary endpoint, stool composition, was determined after 28 days of feeding, and was assessed using ANOVA accompanied by pairwise comparisons. Stool consistency, GI tolerance and hydration were assessed at baseline, day 14 (GI tolerance only) and day 28.Infants fed sn-2 had lower stool palmitate soaps compared to Control (P = 0.0028); while those fed sn-2+OF had reduced stool palmitate soaps compared to both Control and sn-2 (both P < 0.0001). Stool total soaps and calcium were lower in the sn-2+OF group than either Control (P < 0.0001) or sn-2 (P < 0.0001). The HM-fed group had lower stool palmitate soaps, total soaps and calcium (P < 0.0001 for each comparison) than all FF groups. The stool consistency score of the sn-2+OF group was lower than Control and sn-2 (P < 0.0001), but higher than the HM-fed group (P < 0.0001). GI tolerance was similar and anthropometric z-scores were <0.2 SD from the WHO growth standards in all groups, while urinary hydration markers were within normal range for all FF infants.Increasing sn-2 palmitate in infant formula reduces stool palmitate soaps. A combination of high sn-2 palmitate and OF reduces stool palmitate soaps, total soaps and calcium, while promoting softer stools.This study was registered on http://www.clinicaltrials.gov: number NCT02031003.

Project description:ImportanceNearly 4 in 10 expectant mothers in the United States received Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) benefits during pregnancy between 2011 and 2017. Despite public support for the program, empirical evidence of the success of the program varies substantially.ObjectiveTo assess the association of WIC program participation during pregnancy by low-income expectant mothers covered by Medicaid with infant mortality by gestational age at birth and by maternal race/ethnicity in comparison with their counterparts who did not receive WIC benefits.Design, setting, and participantsThis cohort study obtained data from January 1, 2011, to December 31, 2017, from US live birth certificates. Data were from 11 148 261 expectant mothers who delivered live births in states that have implemented the 2003 revision of the US live birth certificate and whose insurance coverage and receipt of WIC benefits were recorded on the birth certificates. Data analysis was performed from June 2019 to October 2019.ExposuresReceipt of WIC benefits during pregnancy.Main outcomes and measuresThe first outcome was gestational age at birth: extremely preterm (<28 weeks), very preterm (28-32 weeks), moderate-to-late preterm (32-37 weeks), and normal term (≥37 weeks) births. The second outcome was death within the first year of life.ResultsAmong the 11 148 261 expectant mothers who delivered live births between 2011 and 2017 and were covered by Medicaid during pregnancy, the modal age at delivery was 20 to 24 years, the predominant race/ethnicity was non-Hispanic white (4 257 790 [38.2%]), and 8 145 770 (73.1%) received WIC benefits during pregnancy. The proportion of expectant mothers covered by Medicaid who also received WIC benefits decreased from 2011 to 2017 (79.3% to 67.9%; P < .001). The odds of preterm birth compared with normal term birth were lower among expectant mothers covered by Medicaid who received WIC benefits during pregnancy compared with their counterparts who did not receive WIC benefits during pregnancy (adjusted proportional odds ratio, 0.87; 95% CI, 0.86-0.87). The odds of mortality within 1 year of birth were lower for infants whose mothers were covered by Medicaid and received WIC benefits during pregnancy compared with those who did not receive WIC benefits during pregnancy (adjusted odds ratio, 0.84; 95% CI, 0.83-0.86).Conclusions and relevanceThis study found that receipt of WIC benefits among expectant mothers with Medicaid coverage was associated with lower risk of preterm birth and infant mortality.

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Dataset Information

Soy protein-based infant formulas with supplemental fructooligosaccharides: gastrointestinal tolerance and hydration status in newborn infants.

Publications

Soy protein-based infant formulas with supplemental fructooligosaccharides: gastrointestinal tolerance and hydration status in newborn infants.

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