Healthy Term Infants Fed Milk-Based Formulas

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

PHASE3

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-08-31

Brief Summary

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The objective is to assess the comparative fat and calcium absorption, and gastrointestinal (GI) tolerance in healthy normal term infants fed powdered milk-based formulas containing different fat blends.

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Detailed Description

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Conditions

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Healthy Term Infant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Powdered milk-based formula, standard fat blend

Group Type ACTIVE_COMPARATOR

A powdered milk-based infant formula, standard fat blend

Intervention Type OTHER

formula to be consumed ad lib

Powder milk-based formula, alternate fat blend

Group Type EXPERIMENTAL

Experimental powdered milk-based infant formula with an alternate fat blend

Intervention Type OTHER

formula to be consumed ad lib

Interventions

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Experimental powdered milk-based infant formula with an alternate fat blend

formula to be consumed ad lib

Intervention Type OTHER

A powdered milk-based infant formula, standard fat blend

formula to be consumed ad lib

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Infant is judged to be in good health.
* Infant is singleton from a full term birth
* Infant's birth weight was \> 2490 g.
* Infant is between 53 and 115 days of age
* Infant is on infant formula and tolerating infant formula feedings
* Parent(s) confirm they will not administer vitamin or mineral supplements, solid foods or juices for the duration of the study, unless instructed otherwise by their healthcare professional.
* Parent(s) and physician agree to discontinue the use of medications or home remedies, herbal preparations that might affect GI tolerance

Exclusion Criteria

Infant has received human milk within 7 days prior to SDay 1.

Any adverse maternal, fetal or infant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development and includes maternal substance abuse

Infant has been treated with antibiotics within 5 days prior to SDay 1

Infant has received probiotics within 5 days prior to SDay 1.

Minimum Eligible Age

53 Days

Maximum Eligible Age

115 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes