Clinical trial NCT02031003: Effect of Infant Formulas Containing a New Fat Blend or the New Fat Blend Plus Fiber in Healthy Term Infants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bottle Feeding
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2014-01-09
Enrollment: 220
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Stool Composition
timeFrame: Day 28
Secondary outcomes:
measure: Stool Consistency determined using a 3-day stool diary
timeFrame: Days 14 and 28
measure: Stool frequency determined using a 3-day stool diary
timeFrame: Day 14 and 28
measure: GI Tolerance
timeFrame: Baseline, Day 14 and Day 28
measure: Incidence of adverse events
timeFrame: From ICF signing until 14 days after last study feeding
measure: Anthropometric measurements (weight, length and head circumference)
timeFrame: Baseline, Day 14 and Day 28
measure: Urine osmolality
timeFrame: Baseline and Day 28
measure: Urine pH
timeFrame: Baseline and Day 28
Other outcomes:
Locations:
city: Linkuo
country: Taiwan
facility: Chang Gung Medical Foundation - LinKuo Branch
state: Tao-Yuan County
city: Hsinchu
country: Taiwan
facility: Mackay Memorial Hospital - Hsinchu Branch
city: Taipei City
country: Taiwan
facility: Mackay Memorial Hospital
city: Taipei
country: Taiwan
facility: Chang Gung Medical Foundation, Taipei Branch
Study officials:
References:
citation: 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.