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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-12-31

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.

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Detailed Description

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Conditions

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Bottle Feeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control

Standard infant formula

Group Type OTHER

Infant formula

Intervention Type DIETARY_SUPPLEMENT

Infant formula

Experimental 1

Standard infant formula containing a new fat blend

Group Type EXPERIMENTAL

Infant formula

Intervention Type DIETARY_SUPPLEMENT

Infant formula

Experimental 2

Standard infant formula containing a new fat blend and fiber

Group Type EXPERIMENTAL

Infant formula

Intervention Type DIETARY_SUPPLEMENT

Infant formula

Human Milk (HM)

Non-randomized Human Milk group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Infant formula

Intervention Type DIETARY_SUPPLEMENT

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

Minimum Eligible Age

25 Days

Maximum Eligible Age

45 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes