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| Name | Class |
|---|---|
| University of Delaware | OTHER |
| Children's Hospital of Philadelphia | OTHER |
| University of Wisconsin, Madison | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Type of Formula: CMF | Active Comparator | Infants are randomized to feed standard cow milk formula during first year of life |
|
| Type of Formula: EHF | Experimental | Infants are randomized to feed extensively hydrolyzed infant formula during first year of life |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Type of Formula | Other | infant formula |
|
| 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) |
| 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 |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Julie A Mennella, PhD | Monell Chemical Senses Center | Principal Investigator |
| Jillian Trabulsi, PhD | University of Delaware | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Monell Chemical Senses Center | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21187303 | Background | 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. | |
| 8960567 | Background | 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. |
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Energy balance measures at 0.75, 3.5 and 12.5 months of age
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From 2012 to 2015, newly parturient women whose decision not to lactate was firmly established were recruited through ads in regional newspapers, websites and hospitals in the greater Philadelphia area.
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| ID | Title | Description |
|---|---|---|
| FG000 | Type of Formula: CMF | infant is randomized to feed standard cow milk formula during first year of life Type of Formula: infant formula |
| FG001 | Type of Formula: EHF | infant is randomized to feed extensively hydrolyzed infant formula during first year of life Type of Formula: infant formula |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Type of Formula: CMF | infant is randomized to feed standard cow milk infant formula [CMF] during first year of life Type of Formula: infant formula |
| BG001 | Type of Formula: EHF |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | We conducted an intention-to-treat (ITT) analyses on 113 infants regardless of study withdrawal. | Posted | Mean | Standard Error | Z score | 0.5 to 12.5 months with followup visit at 18.5 mos |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Type of Formula: CMF | infant is randomized to feed standard cow milk formula during first year of life Type of Formula: infant formula |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julia A. Mennella, PhD | Monell Chemical Senses Center | 267-519-4880 | mennella@monell.org |
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Between- and within-subject longitudinal trial
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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 |
| 21310829 | Background | 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. |
| 30295700 | Result | 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. |
| 30629845 | Result | 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. |
| 41082983 | Derived | 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. |
| 37292800 | Derived | 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. |
| 32553836 | Derived | 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. |
infant is randomized to feed extensively hydrolyzed protein infant formula [EHF] first year of life
Type of Formula: infant formula
| BG002 | Total | Total of all reporting groups |
| Months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| TAS2R38 genotype, A49P allele; infants | Count of Participants | Participants |
|
| Type of Formula: EHF |
Infant is randomized to be fed extensively protein hydrolyzed infant formula during first year of life Type of Formula: EHF |
|
|
|
| Primary | 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). | We conducted an intention-to-treat (ITT) analyses on 113 infants regardless of study withdrawal. | Posted | Mean | Standard Error | Z score | 0.5 to 12.5 months with followup visit at 18.5 mos |
|
|
|
|
| Primary | 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). | We conducted an intention-to-treat (ITT) analyses on 113 infants regardless of study withdrawal. | Posted | Mean | Standard Error | Z score | 0.5 to 12.5 months with followup visit at 18.5 mos |
|
|
|
|
| Primary | 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 | Intent-to-treat analysis (N=113). | Posted | Mean | Standard Error | kcal per day | 0.75, 3.5, 12.5 mos |
|
|
|
|
| Primary | 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. | Intent-to-treat analysis (N=113). | Posted | Mean | Standard Error | kcal per day | 0.75, 3.5, 12.5 mos |
|
|
|
|
| Primary | 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 | Intent-to-treat analysis (N=113). | Posted | Mean | Standard Error | kcal per day | 0.75, 3.5, 12.5 mos |
|
|
|
|
| Primary | Energy Balance: Energy Loss in Stools | Stool EL (kcal/day) was determined from 3-day stool collection by bomb calorimetry at each timepoint | Intent-to-treat analysis (N=113). | Posted | Mean | Standard Error | kcal per day | 0.75, 3.5, 12.5 mos |
|
|
|
|
| Secondary | 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. | Some mothers responded N/A on questions related to restrictive feeding styles and thus score for this subscale could not be computed. | Posted | Mean | Standard Error | Units on a scale | 0.5 months |
|
|
|
| 0 |
| 59 |
| 0 |
| 59 |
| 0 |
| 59 |
| EG001 | Type of Formula: EHF | infant is randomized to feed extensively hydrolyzed infant formula during first year of life Type of Formula: infant formula | 0 | 54 | 0 | 54 | 0 | 54 |
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| Weight for Age Z score, 0.75 mos |
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| Weight for Age Z score, 1.5 mos |
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| Weight for Age Z score, 2.5 mos |
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| Weight for Age Z score, 3.5 mos |
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| Weight for Age Z score, 4.5 mos |
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| Weight for Age Z score, 5.5 mos |
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| Weight for Age Z score, 6.5 mos |
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| Weight for Age Z score, 7.5 mos |
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| Weight for Age Z score, 8.5 mos |
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| Weight for Age Z score, 9.5 mos |
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| Weight for Age Z score, 10.5 mos |
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| Weight for Age Z score, 11.5 mos |
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| Weight for Age Z score, 12.5 mos |
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| Weight for Age Z score, 18.5 mos |
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| Length for Age Z score, 18.5 mos |
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| Length for Age Z score, 0.75 mos |
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| Length for Age Z score, 1.5 mos |
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| Length for Age Z score, 2.5 mos |
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| Length for Age Z score, 3.5mos |
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| Length for Age Z score, 4.5 mos |
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| Length for Age Z score, 5.5 mos |
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| Length for Age Z score, 6.5 mos |
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| Length for Age Z score, 7.5 mos |
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| Length for Age Z score, 8.5 mos |
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| Length for Age Z score, 9.5 mos |
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| Length for Age Z score, 10.5 mos |
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| Length for Age Z score, 11.5 mos |
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| Length for Age Z score, 12.5 mos |
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| Length for Age Z score, 18.5 mos |
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| Energy Intake from Other Sources, 0.75 months |
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| Energy Intake from Formula, 3.5 mos |
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| Energy Intake from Other Sources, 3.5 mos |
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| Energy Intake from Formula, 12.5 mos |
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| Energy Intake from Other Sources, 12.5 mos |
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| Sleeping Energy Expenditure, 3.5 months |
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| Sleeping Energy Expenditure, 12.5 months |
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| Total energy expenditure, 3.5 months |
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| Total energy expenditure, 12.5 months |
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| Energy Loss in Stools, 3.5 months |
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| Energy Loss in Stools, 12.5 months |
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| Restrictive Feeding Style, 0.5 mos |
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| Pressure to Eat Feeding Style, 0.5 mos |
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| Responsive Feeding Styly, 0.5 mos |
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