Healthy InfantsNCT00957892
Effects of Infant Formula Composition on Infant Feeding Behaviors
An observational study of Healthy Infants, run by Monell Chemical Senses Center at 1 site in United States.
Trial summary
There is a paucity of information on whether and how the composition of formulas fed to infants influences their short-term feeding behaviors during the first few months of life. Read more about this study
- Who is it for?
- Ages 1 month to 4 monthsHealthy volunteers can take part
- Conditions the study is for
- Healthy Infants
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Mar 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
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 month to 4 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Mothers with healthy infants who are between the ages of 1 to 4 months and are exclusively feeding cows milk-based formulas will be recruited from the Philadelphia area for this within-subject experimental research study.
Who may be able to join
- Healthy, term infants of any racial background
- Infants may be of either sex
- Infants must be between 1 and 4 months of age
- Infants must be exclusively feeding a cow's milk-based formula
- Mothers must be over 18 years of age
Who cannot join
- Infants who were preterm
- Infants who have medical conditions that interfere with feeding or eating
- No major complications during pregnancy or at birth
Trial locations and contacts
1 site in 1 country.
United States1 site
Monell Chemical Senses Center
Philadelphia, Pennsylvania, 19104
About this study
There is a paucity of information on whether and how the composition of formulas fed to infants influences their short-term feeding behaviors during the first few months of life. The purpose of this study is to investigate whether the composition of infant formula affects infants' feeding behaviors, in particular, how much formula is consumed within a given feed (i.e., measure of satiation) and how much time elapses after the feed until the infant exhibits signs of hunger (i.e., measure of satiety). The investigators will also examine the relationship between the composition of infant formula consumed and infant temperature, activity, sleep, and mothers' perceptions of infants' intake and regulatory behaviors.
Read the detailed description
This is a within-subject, 3-day study. Each mother-infant dyad will visit the Monell Center three times, for 5 hours each time. The protocol during the three visits will be identical. Upon arrival, the infant will be changed into a light-weight cotton body suit. Infants and mothers will be weighed and measured for height. An activity sensor will be placed on the infant and temperature sensors will be placed on both the infant and the mother. When the infant signals hunger, he/she will be fed one of three formulas in randomized order:
- cow milk based-formula (Enfamil)
- protein hydrolysate formula (Nutramigen)
- cow milk-based formula with glutamate level similar to Nutramigen (Enfamilg)
Intake will be monitored and all feeds will be videotaped. In between feedings, infants will rest or sleep on their backs in a crib and mothers will fill out questionnaires.
- Conditions
- Healthy Infants
- Keywords
- Healthy Infants, Satiation, Satiety, Intake Regulation, Infant Feeding, Infant Formula Feeding
What is being measured
The primary outcome is the main question the study is designed to answer.
Satiation: volume of formula consumed within a feed
Measured: 5-hour period
Satiety: the duration between feedings
Measured: 5-hour period
Secondary outcomes (3)
Infant temperature change
Measured: 5-hour period
Infant sleep and activity patterns
Measured: 5-hour period
Maternal perceptions
Measured: 5-hour period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2009 (estimated)
- Study startMay 2009
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy InfantsStudies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Monell Chemical Senses Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ajinomoto USA, INC., Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Julie A. Mennella, Monell Chemical Senses Center
- Investigators
- Julie A Mennella, Ph.D., Principal investigator, Monell Chemical Senses Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00957892
- Sponsor's protocol ID
- 809649
- Other IDs
- R01HD037119, F32HD063343-01A1
- Status last verified
- Dec 2017
- First submitted
- 12 Aug 2009
- Last updated
- 18 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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 8960567Ventura AK, Beauchamp GK, Mennella JA. Infant regulation of intake: the effect of free glutamate content in infant formulas. Am J Clin Nutr. 2012 Apr;95(4):875-81. doi: 10.3945/ajcn.111.024919. Epub 2012 Feb 22.
PubMed 22357724
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Infant Formula Composition on Infant Feeding Behaviors
- ClinicalTrials.gov ID
- NCT00957892
- Acronym / sponsor ID
- 809649
- Conditions
- Healthy Infants
- Keywords
- Healthy Infants, Satiation, Satiety, Intake Regulation, Infant Feeding, Infant Formula Feeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Monell Chemical Senses CenterUniversity, hospital or other
- Collaborators
- Ajinomoto USA, INC., Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- May 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 13 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is a paucity of information on whether and how the composition of formulas fed to infants influences their short-term feeding behaviors during the first few months of life. The purpose of this study is to investigate whether the composition of infant formula affects infants' feeding behaviors, in particular, how much formula is consumed within a given feed (i.e., measure of satiation) and how much time elapses after the feed until the infant exhibits signs of hunger (i.e., measure of satiety). The investigators will also examine the relationship between the composition of infant formula consumed and infant temperature, activity, sleep, and mothers' perceptions of infants' intake and regulatory behaviors.
Detailed description
This is a within-subject, 3-day study. Each mother-infant dyad will visit the Monell Center three times, for 5 hours each time. The protocol during the three visits will be identical. Upon arrival, the infant will be changed into a light-weight cotton body suit. Infants and mothers will be weighed and measured for height. An activity sensor will be placed on the infant and temperature sensors will be placed on both the infant and the mother. When the infant signals hunger, he/she will be fed one of three formulas in randomized order:
- cow milk based-formula (Enfamil)
- protein hydrolysate formula (Nutramigen)
- cow milk-based formula with glutamate level similar to Nutramigen (Enfamilg)
Intake will be monitored and all feeds will be videotaped. In between feedings, infants will rest or sleep on their backs in a crib and mothers will fill out questionnaires.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 month to 4 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Mothers with healthy infants who are between the ages of 1 to 4 months and are exclusively feeding cows milk-based formulas will be recruited from the Philadelphia area for this within-subject experimental research study.
Key inclusion criteria (5 listed)
- Healthy, term infants of any racial background
- Infants may be of either sex
- Infants must be between 1 and 4 months of age
- Infants must be exclusively feeding a cow's milk-based formula
- Mothers must be over 18 years of age
Key exclusion criteria (3 listed)
- Infants who were preterm
- Infants who have medical conditions that interfere with feeding or eating
- No major complications during pregnancy or at birth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Satiation: volume of formula consumed within a feed
Time frame: 5-hour period
Satiety: the duration between feedings
Time frame: 5-hour period
3 secondary outcomes
Infant temperature change
Time frame: 5-hour period
Infant sleep and activity patterns
Time frame: 5-hour period
Maternal perceptions
Time frame: 5-hour period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2017.
- 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.
- Derived from this study: PubMed 22357724Ventura AK, Beauchamp GK, Mennella JA. Infant regulation of intake: the effect of free glutamate content in infant formulas. Am J Clin Nutr. 2012 Apr;95(4):875-81. doi: 10.3945/ajcn.111.024919. Epub 2012 Feb 22.
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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, Ph.D. principal investigator
Monell Chemical Senses Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Infants, 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 3 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 18 Dec 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Satiation: volume of formula consumed within a feed (time frame: 5-hour period). The study lists 2 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 NCT00957892, which also lists 2 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 18 Dec 2017.