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

Not Applicable

Completed

• Conditions: Bottle Feeding
• Interventions: Dietary Supplement: Infant formula

• Registration Number: NCT02031003
• Lead Sponsor: Société des Produits Nestlé (SPN)

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Study First Submitted: 2013-12-23
• Status Verified: 2014-01
• Study First Submitted QC: 2014-01-07
• Last Update Submitted: 2014-01-07
• Study First Posted: 2014-01-09
• Last Update Posted: 2014-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental 2	Infant formula	Standard infant formula containing a new fat blend and fiber
Control	Infant formula	Standard infant formula
Experimental 1	Infant formula	Standard infant formula containing a new fat blend

Primary Outcome Measures

Name	Time	Method
Stool Composition	Day 28	Stool soap and non-soap fatty acids, total fatty acids, minerals, and other stool constituents

Secondary Outcome Measures

Name	Time	Method
Stool Consistency determined using a 3-day stool diary	Days 14 and 28	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).
Stool frequency determined using a 3-day stool diary	Day 14 and 28	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.
Incidence of adverse events	From ICF signing until 14 days after last study feeding
Anthropometric measurements (weight, length and head circumference)	Baseline, Day 14 and Day 28	Observed anthropometry measurements and derived z-scores will be determined and summarized by feeding group and by study visit.
Urine pH	Baseline and Day 28	Measure of hydration status
GI Tolerance	Baseline, Day 14 and Day 28	GI tolerance assessed by the Infant Gastrointestinal Symptom Questionnaire (IGSQ)
Urine osmolality	Baseline and Day 28	Measure of hydration status

Trial Locations

Locations (4)

Chang Gung Medical Foundation - LinKuo Branch; 🇨🇳 Linkuo, Tao-Yuan County, Taiwan

Mackay Memorial Hospital - Hsinchu Branch; 🇨🇳 Hsinchu, Taiwan

Mackay Memorial Hospital; 🇨🇳 Taipei City, Taiwan

Chang Gung Medical Foundation, Taipei Branch; 🇨🇳 Taipei, Taiwan