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

N/ACompletedNCT02031003

Société des Produits Nestlé (SPN)220 enrolled

Overview

* 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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

220

Conditions

Bottle Feeding

Interventions

Eligibility

Sex: ALLMin age: 25 DaysMax age: 45 DaysHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (4)

Chang Gung Medical Foundation - LinKuo Branch

Linkuo, Tao-Yuan County, Taiwan

Mackay Memorial Hospital - Hsinchu Branch

Hsinchu, Taiwan

Chang Gung Medical Foundation, Taipei Branch

Taipei, Taiwan

Mackay Memorial Hospital

Taipei, Taiwan

Outcomes

Primary Outcomes

Stool Composition

Stool soap and non-soap fatty acids, total fatty acids, minerals, and other stool constituents

Time frame: Day 28

Secondary Outcomes

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).

Time frame: 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.

Time frame: Day 14 and 28

GI Tolerance

GI tolerance assessed by the Infant Gastrointestinal Symptom Questionnaire (IGSQ)

Time frame: Baseline, Day 14 and Day 28

Incidence of adverse events

Time frame: From ICF signing until 14 days after last study feeding

Anthropometric measurements (weight, length and head circumference)

Observed anthropometry measurements and derived z-scores will be determined and summarized by feeding group and by study visit.

Time frame: Baseline, Day 14 and Day 28

Urine osmolality

Measure of hydration status

Time frame: Baseline and Day 28

Urine pH

Measure of hydration status

Time frame: Baseline and Day 28