Soy protein-based infant formulas with supplemental fructooligosaccharides: gastrointestinal tolerance and hydration status in newborn infants.
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, &amp; 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.
Abbott Nutrition, Abbott Laboratories, Columbus, OH 43219, USA. john.lasekan@abbott.com.
John
J
Lasekan
Abbott Nutrition, Abbott Laboratories, Columbus, OH 43219, USA. geraldine.baggs@abbott.com.
Geraldine
G
Baggs
Abbott Nutrition, Abbott Laboratories, Columbus, OH 43219, USA. sonja.acosta@abbott.com.
Sonja
S
Acosta
Abbott Nutrition, Abbott Laboratories, Columbus, OH 43219, USA. amy.mackey@abbott.com.
Amy
A
Mackey
D001835:Body Weight; D002338:Carotenoids / Q000008:administration & dosage; D019587:Dietary Supplements; D004311:Double-Blind Method; D005243:Feces; D005260:Female; D041981:Gastrointestinal Tract / Q000187:drug effects* / Q000378:metabolism; D006801:Humans; D007223:Infant; D041943:Infant Formula / Q000008:administration & dosage* / Q000737:chemistry; D007231:Infant, Newborn; D014975:Lutein / Q000008:administration & dosage; D000077276:Lycopene; D008297:Male; D009844:Oligosaccharides / Q000008:administration & dosage* / Q000737:chemistry; D030262:Soybean Proteins / Q000008:administration & dosage* / Q000737:chemistry; D019207:beta Carotene / Q000008:administration & dosage
D009844:Oligosaccharides; D030262:Soybean Proteins; C116580:fructooligosaccharide; D019207:beta Carotene; D002338:Carotenoids; D000077276:Lycopene; D014975:Lutein