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Completed

NCT Number: NCT01700205

Effect of Infant Formula on Energy Balance

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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Key information

Conditions

Development

Age range

1 week–3 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Monell Chemical Senses Center

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A healthy, term (≥37 and ≤42 week gestation at birth), singleton infant.
  • Birth weight between 2500 - 4500 grams.
  • At the time of enrollment, infant must be ≤14 days old (Date of birth=day 0).
  • Mother must be 18 years or older.
  • 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

  • Mother had gestational diabetes during pregnancy
  • Infant has condition requiring infant feedings other than feeding cow milk formula from a bottle.
  • Infant has major congenital malformations (i.e. cleft palate, hemangiomas, extremity malformation).
  • Infant has suspected or documented systemic or congenital infections (e.g., human immunodeficiency virus, cytomegalovirus).
  • 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.
  • Dyad be the relative (son, daughter, niece, nephew, cousin, aunt, uncle, sibling) of ancillary personnel connected with the study.

Treatment and study plan

Type of Formula

Other

infant formula

Other names: cow milk formula (CMF), protein hydrolysate formula (EHF)

Primary outcomes

  1. Growth, Weight for Length (WLZ) Z Scores

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

    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).

  2. Growth, Weight for Age (WAZ) Z Score

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

    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).

  3. Growth: Length for Age (LAZ) Z Scores

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

    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).

  4. Energy Balance: Energy Intake From Infant Formula and Other Sources

    Time frame: 0.75, 3.5, 12.5 mos

    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

  5. Energy Balance: Sleeping Energy Expenditure (SEE)

    Time frame: 0.75, 3.5, 12.5 mos

    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.

  6. Energy Balance: Total Energy Expenditure (TEE)

    Time frame: 0.75, 3.5, 12.5 mos

    TEE (kcal/day) was measured over 7 days at each of the three time points (0.75, 3.5 and12.5 mos) using the doubly labeled water method

  7. Energy Balance: Energy Loss in Stools

    Time frame: 0.75, 3.5, 12.5 mos

    Stool EL (kcal/day) was determined from 3-day stool collection by bomb calorimetry at each timepoint

Secondary outcomes

  1. Feeding Behaviors, Maternal Perceptions

    Time frame: 0.5 months

    Maternal perception of infant feeding behavior, using standardized questionnaires (Infant feeding style questionnaire; IFSQ); values ranged from 1 to 5; higher scores reflect more of that feeding style. Only baseline data reported herein.

Sponsors and collaborators

Lead sponsor

Monell Chemical Senses Center

Other

Collaborators

  • Children's Hospital of Philadelphia
  • University of Delaware
  • University of Wisconsin, Madison

Registry information

Official study title

Impact of Diet Composition on Energy Balance and Satiety During Infancy

Acronym: GRO

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Oct 4, 2012
Registry last updated
Nov 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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