DevelopmentGRONCT01700205

Effect of Infant Formula on Energy Balance

A study testing Type of Formula in people with Development, run by Monell Chemical Senses Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 1 week to 3 weeksHealthy volunteers can take part
Conditions the study is for: Development
What is being tested?: Type of Formula
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 113 participants
Where: 1 siteUnited States
Study dates: 2 Nov 2012to 21 Sep 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 1 week to 3 weeks
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Monell Chemical Senses Center
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Impact of Diet Composition on Energy Balance and Satiety During Infancy

Read the 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.

Conditions: Development
Being tested: Type of Formula
Keywords: Formula Feeding, Mother, Moms, Infants, Babies, Baby, growth, energy balance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Type of FormulaOther
Also called cow milk formula (CMF), protein hydrolysate formula (EHF)
infant formula

Study groups in NCT01700205
Study group	Role	What they receive
Type of Formula: CMF	Active comparator	Infants are randomized to feed standard cow milk formula during first year of life Receives: Other: Type of Formula
Type of Formula: EHF	Experimental	Infants are randomized to feed extensively hydrolyzed infant formula during first year of life Receives: Other: Type of Formula

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 0.75, 3.5, 12.5 mos

Secondary outcomes (1)

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.
Measured: 0.5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Nov 201221 Sep 2016

First posted4 Oct 2012 (estimated)
Study start2 Nov 2012
Primary completion17 Mar 2016
Study completion21 Sep 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (8)Papers the sponsor has linked to this study.
Other trials for DevelopmentStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Model description: Between- and within-subject longitudinal trial
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 113 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01700205
Sponsor's protocol ID: HD072307
Acronym: GRO
Status last verified: Nov 2019
First submitted: 2 Oct 2012
Last updated: 22 Nov 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Energy balance measures at 0.75, 3.5 and 12.5 months of age

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.
PubMed 21187303
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.
PubMed 8960567
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.
PubMed 21310829
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.
PubMed 30295700
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.
PubMed 30629845
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.
PubMed 41082983
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.
PubMed 37292800
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.
PubMed 32553836

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingObservational study
Impact of Vestibular Function on Deaf Infants' Activities of Daily Living
Vestibular Dysfunction, Hearing Loss
Active, not recruiting
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Physical Inactivity, Overweight and Obesity
Not yet recruitingObservational study
Development and Multicenter Validation of an Explainable System for Neonatal ARDS-Compatible Phenotyping
Acute Respiratory Distress Syndrome

All Development trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of Diet Composition on Energy Balance and Satiety During Infancy
ClinicalTrials.gov ID: NCT01700205
Acronym / sponsor ID: GRO / HD072307
Conditions: Development
Keywords: Formula Feeding, Mother, Moms, Infants, Babies, Baby, growth, energy balance
Study type: Interventional
Recruitment status: Completed
Enrolment: 113 participants (actual)
Lead sponsor: Monell Chemical Senses CenterUniversity, hospital or other
Collaborators: University of Delaware, Children's Hospital of Philadelphia, University of Wisconsin, Madison
Study start: 2 Nov 2012 (actual)
Primary completion: 17 Mar 2016 (actual)
Study completion: 21 Sep 2016 (actual)
First posted: 4 Oct 2012 (estimated)
Results: Posted 16 Sep 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 2
Model description: Between- and within-subject longitudinal trial

Arm	Type	Receives
Type of Formula: CMF	Active comparator	Other: Type of FormulaInfants are randomized to feed standard cow milk formula during first year of life
Type of Formula: EHF	Experimental	Other: Type of FormulaInfants are randomized to feed extensively hydrolyzed infant formula during first year of life

Who may qualify

Ages: 1 week to 3 weeks
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Type of FormulaAlso: cow milk formula (CMF), protein hydrolysate formula (EHF)infant formula	Other	Type of Formula: CMF, Type of Formula: EHF

Primary outcome

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).
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).
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).
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
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.
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
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

1 secondary outcome

Feeding Behaviors, Maternal Perceptions
Time frame: 0.5 months

Results and safety

Results posted to the registry on 16 Sep 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Type of Formula: CMF	59	44
Type of Formula: EHF	54	39

Primary outcome: Growth, Weight for Length (WLZ) Z Scores

Time frame: 0.5 to 12.5 months with followup visit at 18.5 mos. Mean (Standard Error). Unit: Z score

Measure	Type of Formula: CMF n = 59	Type of Formula: EHF n = 54
Weight for Length Z, 0.5 mos	-0.26 (0.13)	-0.12 (0.13)
Weight for Length Z, 0.75 mos	-0.12 (0.13)	0.13 (0.13)
Weight for Length Z, 1.5 mos	0.24 (0.13)	-0.17 (0.13)
Weight for Length Z, 2.5 mos	0.24 (0.13)	-0.17 (0.13)
Weight for Length Z, 3.5 mos	0.22 (0.13)	-0.38 (0.14)
Weight for Length Z, 4.5 mos	0.39 (0.13)	-0.24 (0.14)
Weight for Length Z, 5.5 mos	0.42 (0.14)	-0.36 (0.14)
Weight for Length Z, 6.5 mos	0.52 (0.14)	0.18 (0.14)

Type of Formula: CMF vs Type of Formula: EHF: Slope: -0.018 (95% CI -0.0363 to -0.0002), p <0.05, Generalized Estimating Equation

Population analysed: We conducted an intention-to-treat (ITT) analyses on 113 infants regardless of study withdrawal.

Primary outcome: Growth, Weight for Age (WAZ) Z Score

Time frame: 0.5 to 12.5 months with followup visit at 18.5 mos. Mean (Standard Error). Unit: Z score

Measure	Type of Formula: CMF n = 59	Type of Formula: EHF n = 54
Weight for Age Z score, 0.5 mos	-0.36 (0.12)	-0.25 (0.13)
Weight for Age Z score, 0.75 mos	-0.41 (0.12)	-0.28 (0.13)
Weight for Age Z score, 1.5 mos	-0.38 (0.12)	-0.61 (0.13)
Weight for Age Z score, 2.5 mos	-0.34 (0.12)	-0.66 (0.13)
Weight for Age Z score, 3.5 mos	-0.14 (0.12)	0.64 (0.13)
Weight for Age Z score, 4.5 mos	0.07 (0.13)	-0.37 (0.13)
Weight for Age Z score, 5.5 mos	0.18 (0.13)	-0.20 (0.13)
Weight for Age Z score, 6.5 mos	0.29 (0.13)	-0.03 (0.13)

Type of Formula: CMF vs Type of Formula: EHF: Slope: -0.023 (95% CI -0.0362 to -0.0093), p = 0.001, Generalized Estimating Equations

Population analysed: We conducted an intention-to-treat (ITT) analyses on 113 infants regardless of study withdrawal.

Primary outcome: Growth: Length for Age (LAZ) Z Scores

Time frame: 0.5 to 12.5 months with followup visit at 18.5 mos. Mean (Standard Error). Unit: Z score

Measure	Type of Formula: CMF n = 59	Type of Formula: EHF n = 54
Length for Age Z score, 0.5 mos	-0.49 (0.14)	-0.46 (0.14)
Length for Age Z score, 0.75 mos	-0.56 (0.14)	0.59 (0.14)
Length for Age Z score, 1.5 mos	-0.55 (0.14)	-0.48 (0.14)
Length for Age Z score, 2.5 mos	-0.57 (0.14)	-0.62 (0.14)
Length for Age Z score, 3.5mos	-0.36 (0.14)	-0.43 (0.15)
Length for Age Z score, 4.5 mos	-0.26 (0.14)	-0.21 (0.15)
Length for Age Z score, 5.5 mos	-0.13 (0.14)	-0.17 (0.15)
Length for Age Z score, 6.5 mos	-0.05 (0.14)	-0.17 (0.15)

Type of Formula: CMF vs Type of Formula: EHF: Slope: -0.02 (95% CI -0.058 to 0.019), p = 0.32, Generalized Estimating Equation

Population analysed: We conducted an intention-to-treat (ITT) analyses on 113 infants regardless of study withdrawal.

Primary outcome: Energy Balance: Energy Intake From Infant Formula and Other Sources

Time frame: 0.75, 3.5, 12.5 mos. Mean (Standard Error). Unit: kcal per day

Measure	Type of Formula: CMF n = 59	Type of Formula: EHF n = 54
Energy Intake from Formula, 0.75 months	466 (14)	383 (15)
Energy Intake from Other Sources, 0.75 months	0 (0)	0 (0)
Energy Intake from Formula, 3.5 mos	628 (21)	596 (21)
Energy Intake from Other Sources, 3.5 mos	11 (5)	10 (6)
Energy Intake from Formula, 12.5 mos	425 (50)	284 (56)
Energy Intake from Other Sources, 12.5 mos	712 (51)	863 (57)

Type of Formula: CMF vs Type of Formula: EHF: p <0.05, Repeated Measures ANOVA

Population analysed: Intent-to-treat analysis (N=113).

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Type of Formula: CMF	0 of 59 (0%)	0 of 59 (0%)	0 of 59
Type of Formula: EHF	0 of 54 (0%)	0 of 54 (0%)	0 of 54

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 21187303Mennella 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.
Background: PubMed 8960567Mennella 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.
Background: PubMed 21310829Mennella 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.
Results publication: PubMed 30295700Mennella 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.
Results publication: PubMed 30629845Mennella 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.
Derived from this study: PubMed 41082983Decker 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.
Derived from this study: PubMed 37292800Mennella 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.
Derived from this study: PubMed 32553836Mennella 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.
Individual participant dataSharing planned: No. Energy balance measures at 0.75, 3.5 and 12.5 months of age

Related trials for Development

Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingObservational study
Impact of Vestibular Function on Deaf Infants' Activities of Daily Living
Vestibular Dysfunction, Hearing Loss
Active, not recruiting
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Physical Inactivity, Overweight and Obesity
Not yet recruitingObservational study
Development and Multicenter Validation of an Explainable System for Neonatal ARDS-Compatible Phenotyping
Acute Respiratory Distress Syndrome

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Julie A Mennella, PhD principal investigator

Monell Chemical Senses Center

Jillian Trabulsi, PhD principal investigator

University of Delaware

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Type of Formula in people with Development, run by Monell Chemical Senses Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Growth, Weight for Length (WLZ) Z Scores (time frame: 0.5 to 12.5 months with followup visit at 18.5 mos). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01700205, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2019.