Effect of Infant Formula on Energy Balance

Monell Chemical Senses Center113 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Enrollment

113

Conditions

Development

Interventions

Type of FormulaOTHER

infant formula

Eligibility

Sex: ALLMin age: 1 WeekMax age: 3 WeeksHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Monell Chemical Senses Center

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Growth, Weight for Length (WLZ) Z Scores

At each visit, infants were weighed and measured to monitor normal growth. These anthropometric data were converted to weight-for-length (WLZ) Zscores using World Health Organization (WHO) growth standards. The Z-score expresses the anthropometric value as a number of standard deviations or Z-scores below or above the reference mean value. Normal range for Z score is -2.0 (minimum) to 2.0 (maximum).

Time frame: 0.5 to 12.5 months with followup visit at 18.5 mos

Growth, Weight for Age (WAZ) Z Score

At each visit, infants were weighed to monitor normal growth. These anthropometric data were converted to Weight for age Z (WAZ) Z scores using World Health Organization (WHO) growth standards. The Z-score expresses the anthropometric value as a number of standard deviations or Z-scores below or above the reference mean value. Normal range for Z score is -2.0 (minimum) to 2.0 (maximum).

Time frame: 0.5 to 12.5 months with followup visit at 18.5 mos

Growth: Length for Age (LAZ) Z Scores

At each visit, infants were measured to monitor normal growth. These anthropometric data were converted to Length for age Z (LAZ) Z scores using World Health Organization (WHO) growth standards. The Z-score expresses the anthropometric value as a number of standard deviations or Z-scores below or above the reference mean value. Normal range for Z score is -2.0 (minimum) to 2.0 (maximum).

Time frame: 0.5 to 12.5 months with followup visit at 18.5 mos

Energy Balance: Energy Intake From Infant Formula and Other Sources

Energy intake (kcal/day) of infant formula and other sources was determined by three-day weighed bottle intake and records of the infants' intake of any liquid or food other than formula during the three days

Time frame: 0.75, 3.5, 12.5 mos

Energy Balance: Sleeping Energy Expenditure (SEE)

Postprandial SEE (kcal/day), a proxy for resting energy expenditure in infant, was measured for a minimum of 30 min by open-circuit, indirect calorimetry using a metabolic cart with canopy hood, in a quiet, thermal-neutral room.

Data from ClinicalTrials.gov

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Effect of Infant Formula on Energy Balance

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes