Clinical Research Directory

Effect of Infant Formulas Containing a New Fat Blend or the New Fat Blend Plus Fiber in Healthy Term Infants

Sponsor: Société des Produits Nestlé (SPN)

Summary

* The primary objective of the study was to compare stool composition (stool soap and non-soap fatty acids, total fatty acids, minerals, and other stool constituents) of infants randomized to receive either standard formula, or 1 of 2 innovative formulas containing a new fat blend or the new fat blend plus fiber. * The secondary objectives were to evaluate among the feeding groups, stool characteristics (stool consistency and frequency), GI tolerance assessed by the Infant Gastrointestinal Symptom Questionnaire (IGSQ), and urinary markers (F2-isoprostanes and 8-hydroxy-2'-deoxyguanosine \[8-OHdG\], and urine osmolality and specific gravity). * The primary safety objective was to describe the frequency of adverse events (AEs) among the formula-fed (FF) groups. * The secondary safety objective was to describe anthropometric measures (weight, length, and head circumference) among the feeding groups.

Official title: Effect of an Infant Formula With High 2-Palmitic Vegetable Oil or an Identical Formula Supplemented With Oligofructose on Stool Composition and Stool Characteristics in Healthy Term Infants in Taiwan

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