Clinical trial NCT01700205: Effect of Infant Formula on Energy Balance
Official title: Impact of Diet Composition on Energy Balance and Satiety During Infancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Development
Keywords: Formula Feeding
Mother
Moms
Infants
Babies
Baby
growth
energy balance
Lead sponsor: Monell Chemical Senses Center
Sponsor class: OTHER
Collaborators: name: University of Delaware
name: Children's Hospital of Philadelphia
name: University of Wisconsin, Madison
First posted: 2012-10-04
Enrollment: 113
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Between- and within-subject longitudinal trial
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Growth, Weight for Length (WLZ) Z Scores
timeFrame: 0.5 to 12.5 months with followup visit at 18.5 mos
measure: Growth, Weight for Age (WAZ) Z Score
timeFrame: 0.5 to 12.5 months with followup visit at 18.5 mos
measure: Growth: Length for Age (LAZ) Z Scores
timeFrame: 0.5 to 12.5 months with followup visit at 18.5 mos
measure: Energy Balance: Energy Intake From Infant Formula and Other Sources
timeFrame: 0.75, 3.5, 12.5 mos
measure: Energy Balance: Sleeping Energy Expenditure (SEE)
timeFrame: 0.75, 3.5, 12.5 mos
measure: Energy Balance: Total Energy Expenditure (TEE)
timeFrame: 0.75, 3.5, 12.5 mos
measure: Energy Balance: Energy Loss in Stools
timeFrame: 0.75, 3.5, 12.5 mos
Secondary outcomes:
measure: Feeding Behaviors, Maternal Perceptions
timeFrame: 0.5 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Monell Chemical Senses Center
state: Pennsylvania
Study officials:
affiliation: Monell Chemical Senses Center
name: Julie A Mennella, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Delaware
name: Jillian Trabulsi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mennella JA, Ventura AK, Beauchamp GK. Differential growth patterns among healthy infants fed protein hydrolysate or cow-milk formulas. Pediatrics. 2011 Jan;127(1):110-8. doi: 10.1542/peds.2010-1675. Epub 2010 Dec 27.
citation: Mennella JA, Beauchamp GK. Developmental changes in the acceptance of protein hydrolysate formula. J Dev Behav Pediatr. 1996 Dec;17(6):386-91. doi: 10.1097/00004703-199612000-00003.
citation: Mennella JA, Lukasewycz LD, Castor SM, Beauchamp GK. The timing and duration of a sensitive period in human flavor learning: a randomized trial. Am J Clin Nutr. 2011 May;93(5):1019-24. doi: 10.3945/ajcn.110.003541. Epub 2011 Feb 10.
citation: Mennella JA, Inamdar L, Pressman N, Schall JI, Papas MA, Schoeller D, Stallings VA, Trabulsi JC. Type of infant formula increases early weight gain and impacts energy balance: a randomized controlled trial. Am J Clin Nutr. 2018 Nov 1;108(5):1015-1025. doi: 10.1093/ajcn/nqy188.
citation: Mennella JA, Papas MA, Reiter AR, Stallings VA, Trabulsi JC. Early rapid weight gain among formula-fed infants: Impact of formula type and maternal feeding styles. Pediatr Obes. 2019 Jun;14(6):e12503. doi: 10.1111/ijpo.12503. Epub 2019 Jan 10.
citation: Mennella JA, Reiter A, Brewer B, Pohlig RT, Stallings VA, Trabulsi JC. Early Weight Gain Forecasts Accelerated Eruption of Deciduous Teeth and Later Overweight Status during the First Year. J Pediatr. 2020 Oct;225:174-181.e2. doi: 10.1016/j.jpeds.2020.06.019. Epub 2020 Jun 15.