Effect of Infant Formula on Energy Balance (GRO)

Impact of Diet Composition on Energy Balance and Satiety During Infancy

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.

Study Overview

• Status: Completed
• Conditions: Development
• Intervention / Treatment: Other: Type of Formula

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.

• Study Type: Interventional
• Enrollment (Actual): 113
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Monell Chemical Senses Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 week to 3 weeks (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Type of Formula: CMF; Infants are randomized to feed standard cow milk formula during first year of life	Other: Type of Formula; infant formula; Other Names: cow milk formula (CMF); protein hydrolysate formula (EHF)
Experimental: Type of Formula: EHF; Infants are randomized to feed extensively hydrolyzed infant formula during first year of life	Other: Type of Formula; infant formula; Other Names: cow milk formula (CMF); protein hydrolysate formula (EHF)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	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	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.	0.75, 3.5, 12.5 mos
Energy Balance: Total Energy Expenditure (TEE)	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	0.75, 3.5, 12.5 mos
Energy Balance: Energy Loss in Stools	Stool EL (kcal/day) was determined from 3-day stool collection by bomb calorimetry at each timepoint	0.75, 3.5, 12.5 mos

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feeding Behaviors, Maternal Perceptions	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.	0.5 months

Collaborators and Investigators

• Sponsor: Monell Chemical Senses Center
• Collaborators: Children's Hospital of Philadelphia; University of Wisconsin, Madison; University of Delaware
• Investigators: Principal Investigator: Jillian Trabulsi, PhD, University of Delaware

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2012
• Primary Completion (Actual): March 17, 2016
• Study Completion (Actual): September 21, 2016

Study Registration Dates

• First Submitted: October 2, 2012
• First Submitted That Met QC Criteria: October 3, 2012
• First Posted (Estimate): October 4, 2012

Study Record Updates

• Last Update Posted (Actual): November 22, 2019
• Last Update Submitted That Met QC Criteria: November 20, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: growth; Infants; Babies; Mother; energy balance; Formula Feeding; Moms; Baby
• Other Study ID Numbers: HD072307

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Energy balance measures at 0.75, 3.5 and 12.5 months of age

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No