NCT01700205

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 4, 2012

Completed
29 days until next milestone

Study Start

First participant enrolled

November 2, 2012

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2016

Completed
3 years until next milestone

Results Posted

Study results publicly available

September 16, 2019

Completed
Last Updated

November 22, 2019

Status Verified

November 1, 2019

Enrollment Period

3.4 years

First QC Date

October 2, 2012

Results QC Date

March 18, 2019

Last Update Submit

November 20, 2019

Conditions

Development

Keywords

Formula FeedingMotherMomsInfantsBabiesBabygrowthenergy balance

Outcome Measures

Primary Outcomes (7)

  • 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 Outcomes (1)

  • Feeding Behaviors, Maternal Perceptions

    0.5 months

Study Arms (2)

Type of Formula: CMF

ACTIVE COMPARATOR

Infants are randomized to feed standard cow milk formula during first year of life

Other: Type of Formula

Type of Formula: EHF

EXPERIMENTAL

Infants are randomized to feed extensively hydrolyzed infant formula during first year of life

Other: Type of Formula

Interventions

Type of FormulaOTHER

infant formula

Also known as: cow milk formula (CMF), protein hydrolysate formula (EHF)
Type of Formula: CMFType of Formula: EHF

Eligibility Criteria

Age1 Week - 3 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Monell Chemical Senses Center

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (8)

  • 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.

    PMID: 21187303BACKGROUND

  • 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.

    PMID: 8960567BACKGROUND

  • 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.

    PMID: 21310829BACKGROUND

  • 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.

    PMID: 30295700RESULT

  • 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.

    PMID: 30629845RESULT

  • Decker JE, Mennella JA, Brewer BC, Robson SM, Millen AE, Delahanty MT, Smethers AD, Trabulsi JC. Association Between Diet Patterns of Human Infants and Growth Differs Across Randomized Formula Groups in the First 18.5 Months. J Nutr. 2025 Dec;155(12):4390-4400. doi: 10.1016/j.tjnut.2025.10.007. Epub 2025 Oct 11.

    PMID: 41082983DERIVED

  • Mennella JA, Smethers AD, Delahanty MT, Stallings VA, Trabulsi JC. Glutamic Acid Intake by Formula-Fed Infants: Are Acceptable Daily Intakes Feasible? Res Sq [Preprint]. 2023 May 17:rs.3.rs-2907953. doi: 10.21203/rs.3.rs-2907953/v1.

    PMID: 37292800DERIVED

  • 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.

    PMID: 32553836DERIVED

Results Point of Contact

Title
Julia A. Mennella, PhD
Organization
Monell Chemical Senses Center
mennella@monell.org
267-519-4880

Study Officials

  • Julie A Mennella, PhD

    Monell Chemical Senses Center

    PRINCIPAL INVESTIGATOR

  • Jillian Trabulsi, PhD

    University of Delaware

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Between- and within-subject longitudinal trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Member

Study Record Dates

First Submitted

October 2, 2012

First Posted

October 4, 2012

Study Start

November 2, 2012

Primary Completion

March 17, 2016

Study Completion

September 21, 2016

Last Updated

November 22, 2019

Results First Posted

September 16, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Energy balance measures at 0.75, 3.5 and 12.5 months of age

Locations

US(1)