NCT02031003

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: Société des Produits Nestlé (SPN) · Industry
• Sex: All
• Age: 25 Days – 45 Days
• Healthy volunteers: Accepted

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.

Conditions

• Bottle Feeding

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Infant formula	Infant formula

Timeline

• Start date: 2010-09-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2014-01-09
• Last updated: 2026-03-13

Locations

4 sites across 1 country: Taiwan