Effect of Infant Formula on Energy Balance (GRO)

• ClinicalTrials.gov Identifier: NCT01700205
• Recruitment Status: Completed
• First Posted: October 4, 2012
• Results First Posted: September 16, 2019
• Last Update Posted: November 22, 2019
• Sponsor: Monell Chemical Senses Center
• Collaborators: University of Delaware; Children's Hospital of Philadelphia; University of Wisconsin, Madison
• Information provided by (Responsible Party): Julie A. Mennella, PhD, Monell Chemical Senses Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Development	Other: Type of Formula	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 113 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Between- and within-subject longitudinal trial
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Impact of Diet Composition on Energy Balance and Satiety During Infancy
• Actual Study Start Date: November 2, 2012
• Actual Primary Completion Date: March 17, 2016
• Actual Study Completion Date: September 21, 2016

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: up to 3 Weeks (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

United States, Pennsylvania

Monell Chemical Senses Center

Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

Monell Chemical Senses Center

University of Delaware

Children's Hospital of Philadelphia

University of Wisconsin, Madison

Investigators

• Principal Investigator: Julie A Mennella, PhD; Monell Chemical Senses Center
• Principal Investigator: Jillian Trabulsi, PhD; University of Delaware

More Information

Publications of Results:

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.

Other 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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Julie A. Mennella, PhD, Member, Monell Chemical Senses Center
• ClinicalTrials.gov Identifier: NCT01700205
• Other Study ID Numbers: HD072307
• First Posted: October 4, 2012
• Results First Posted: September 16, 2019
• Last Update Posted: November 22, 2019
• Last Verified: November 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Energy balance measures at 0.75, 3.5 and 12.5 months of age

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Julie A. Mennella, PhD, Monell Chemical Senses Center:

Formula Feeding; Mother; Moms; Infants; Babies; Baby; growth; energy balance