Effect of Infant Formulas Containing a New Fat Blend or the New Fat Blend Plus Fiber in Healthy Term Infants (9055A1-2000)

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

• 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.

Study Overview

• Status: Completed
• Conditions: Bottle Feeding
• Intervention / Treatment: Dietary supplement: Infant formula

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Hsinchu, Taiwan
    • Mackay Memorial Hospital - Hsinchu Branch
  • Taipei, Taiwan
    • Mackay Memorial Hospital
  • Taipei, Taiwan
    • Chang Gung Medical Foundation, Taipei Branch
  • Tao-Yuan County
    • Linkou District, Tao-Yuan County, Taiwan
      • Chang Gung Medical Foundation - Linkou Branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 weeks to 1 month (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy, term (no less than 37 weeks and no greater than 42 weeks) singleton infants; between 25 days to 45 days post natal age (date of birth = Day 0) and weight for age ≥3rd and ≤97th percentiles according to Taiwan growth charts at the time of study entry.
• Human milk fed infants were exclusively consuming and tolerating HM and the mother must have made the decision to continue to exclusively breastfeed.
• Formula-fed infants were exclusively consuming and tolerating a cow's milk infant formula and parents/LAR must have previously made the decision to continue to exclusively formula feed.

Exclusion Criteria:

• Infants receiving any amount of supplemental HM with infant formula feeding or vice versa
• Family history of siblings with documented cow's milk protein intolerance/allergy
• Major congenital malformations, suspected or documented systemic or congenital infections, evidence systemic diseases

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control; Standard infant formula	Dietary supplement: Infant formula; Infant formula
Experimental: Experimental 1; Standard infant formula containing a new fat blend	Dietary supplement: Infant formula; Infant formula
Experimental: Experimental 2; Standard infant formula containing a new fat blend and fiber	Dietary supplement: Infant formula; Infant formula
No Intervention: Human Milk (HM); Non-randomized Human Milk group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stool Composition	Stool soap and non-soap fatty acids, total fatty acids, minerals, and other stool constituents	Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stool Consistency determined using a 3-day stool diary	Stool consistency data is collected using a 3-day stool diary completed by parents just prior to the Day 14 and Day 28 clinic visits. Average stool consistency scores are recorded on a validated 5-point scale (1 = Watery, 2 = Runny, 3 = Mushy Soft, 4 = Formed, 5 = Hard).	Days 14 and 28
Stool frequency determined using a 3-day stool diary	Stool frequency data is collected using a 3-day stool diary completed by parents just prior to the Day 14 and Day 28 clinic visits. The average number of stools per day is determined for each consecutive 3-day period.	Day 14 and 28
GI Tolerance	GI tolerance assessed by the Infant Gastrointestinal Symptom Questionnaire (IGSQ)	Baseline, Day 14 and Day 28
Incidence of adverse events		From ICF signing until 14 days after last study feeding
Urine osmolality	Measure of hydration status	Baseline and Day 28
Urine pH	Measure of hydration status	Baseline and Day 28
Anthropometric measurements	The anthropometry measurements will be determined by feeding group and by study visit.	Baseline, Day 14 and Day 28
Anthropometric measurements (z-scores)	The z-scores will be determined by feeding group and by study visit.	Baseline, Day 14 and Day 28

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)

Publications and helpful links

General Publications

• Nowacki J, Lee HC, Lien R, Cheng SW, Li ST, Yao M, Northington R, Jan I, Mutungi G. Stool fatty acid soaps, stool consistency and gastrointestinal tolerance in term infants fed infant formulas containing high sn-2 palmitate with or without oligofructose: a double-blind, randomized clinical trial. Nutr J. 2014 Nov 5;13:105. doi: 10.1186/1475-2891-13-105.

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: December 23, 2013
• First Submitted That Met QC Criteria: January 7, 2014
• First Posted (Estimated): January 9, 2014

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Feeding Behavior; Bottle Feeding; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Beverages; Foods, Specialized; Milk Substitutes; Food, Formulated; Infant Food; Infant Formula
• Other Study ID Numbers: B3611001