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

TERMINATED

Clinical Phase

NA

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-02-28

Brief Summary

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This is a prospective, double blind, crossover study in healthy infants randomized to one of two study formulas. The trial will consist of two 21 day study feeding periods separated by a study washout period.

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Detailed Description

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Conditions

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Infants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Standard Milk-based Formula Containing Carotenoid

milk-based ready to feed infant formula

Group Type ACTIVE_COMPARATOR

Standard Milk-based Formula Containing Carotenoid

Intervention Type OTHER

Fed ad libitum

Investigational Milk-based Formula Containing Carotenoid

investigational milk-based ready to feed infant formula

Group Type EXPERIMENTAL

Investigational Milk-based Formula Containing Carotenoid

Intervention Type OTHER

Fed ad libitum

Interventions

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Standard Milk-based Formula Containing Carotenoid

Fed ad libitum

Intervention Type OTHER

Investigational Milk-based Formula Containing Carotenoid

Fed ad libitum

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Infant is in good health
* Infant is a singleton from a full term birth with a gestational age of 37-42 weeks
* Infant's birth weight was \> 2490 g (\~5 lbs 8 oz)
* Infant is between 14 and 28 days of age
* Parent(s) confirm intention to feed their infant the study product(s) as the sole source of nutrition for the duration of the study
* Parent(s) confirm intention not to administer vitamin or mineral supplements, DHA and ARA supplements, solid foods/juices to their infant from enrollment through the duration of the study

Exclusion Criteria

* An adverse maternal, fetal or infant medical history that has potential for effects on tolerance, growth, and/or development.
* Infants using medications (including OTC), home remedies, herbal preparations, probiotics or rehydration fluids that might affect gastrointestinal (GI) tolerance

Minimum Eligible Age

14 Days

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes