Effect of Infant Formula on Energy Balance

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

113 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-02

Study Completion Date

2016-09-21

Brief Summary

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The overarching goal of the research we propose here is to conduct a randomized clinical trial to specify the physiologic and behavioral mechanisms by which infant-formula composition affects all aspects of energy balance and growth during the first years of life.

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Detailed Description

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This is a randomized clinical trial of infants whose parents decided to formula feed them; mother-infant dyads will be randomized when infant is 2 weeks of age to one of 2 groups. The groups will differ in the composition of the formula fed to the infant during the first year of life.

Conditions

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Development

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Between- and within-subject longitudinal trial

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Type of Formula: CMF

Infants are randomized to feed standard cow milk formula during first year of life

Group Type ACTIVE_COMPARATOR

Type of Formula

Intervention Type OTHER

infant formula

Type of Formula: EHF

Infants are randomized to feed extensively hydrolyzed infant formula during first year of life

Group Type EXPERIMENTAL

Type of Formula

Intervention Type OTHER

infant formula

Interventions

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Type of Formula

infant formula

Intervention Type OTHER

Other Intervention Names

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cow milk formula (CMF) protein hydrolysate formula (EHF)

Eligibility Criteria

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Inclusion Criteria

1. A healthy, term (≥37 and ≤42 week gestation at birth), singleton infant.
2. Birth weight between 2500 - 4500 grams.
3. At the time of enrollment, infant must be ≤14 days old (Date of birth=day 0).
4. Mother must be 18 years or older.
5. Infant must be consuming a standard cow's milk protein infant formula and have been receiving a standard cow's milk protein infant formula for at least the past 2 days prior to enrollment.

Exclusion Criteria

1. Mother had gestational diabetes during pregnancy
2. Infant has condition requiring infant feedings other than feeding cow milk formula from a bottle.
3. Infant has major congenital malformations (i.e. cleft palate, hemangiomas, extremity malformation).
4. Infant has suspected or documented systemic or congenital infections (e.g., human immunodeficiency virus, cytomegalovirus).
5. Infant has evidence of significant cardiac, respiratory, endocrinologic, hematologic, gastrointestinal, or other systemic diseases. For example, infant must not be receiving insulin or growth hormone.
6. Dyad be the relative (son, daughter, niece, nephew, cousin, aunt, uncle, sibling) of ancillary personnel connected with the study.

Minimum Eligible Age

1 Week

Maximum Eligible Age

3 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes