Healthy Term Infants Fed Milk-Based Formulas

Healthy Term Infants Fed Milk-Based Formulas With Different Fat Blends

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01617889

Enrollment

Registered

2012-06-13

Start date

2011-03-31

Completion date

2012-08-31

Last updated

2013-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Term Infant

Brief summary

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.

Interventions

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

formula to be consumed ad lib

OTHERA powdered milk-based infant formula, standard fat blend

formula to be consumed ad lib

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

53 Days to 115 Days

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
calcium absorption	8 days	as measured in stool

Secondary

Measure	Time frame	Description
stool consistency	28 days	measured on 5 point scale
fat absorption	8 days	as measured in stool
average number of stools per day	28 days	—
percent of feedings with spit up/vomit associated with feeding per day.	28 days	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026