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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Bottle Feeding

Intervention / Treatment
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* Dietary Supplement: Infant formula


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Days
Maximum Age: 45 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 | 
| 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. | Baseline, Day 14 and Day 28 | 
| Urine osmolality | Measure of hydration status | Baseline and Day 28 | 
| Urine pH | Measure of hydration status | Baseline and Day 28 |