Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2025-12-26 @ 7:22 AM
Study NCT ID:
NCT00957892
Status:
COMPLETED
Last Update Posted:
2017-12-18
First Post:
2009-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Infant Formula Composition on Infant Feeding Behaviors
Sponsor:
Monell Chemical Senses Center
Organization:
Study Overview
Official Title:
Effects of Infant Formula Composition on Infant Feeding Behaviors
Status:
COMPLETED
Status Verified Date:
2017-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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. 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:
1. cow milk based-formula (Enfamil)
2. protein hydrolysate formula (Nutramigen)
3. 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.
1. cow milk based-formula (Enfamil)
2. protein hydrolysate formula (Nutramigen)
3. 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01HD037119 | NIH | None | https://reporter.nih.gov/quic… | View |
| F32HD063343-01A1 | NIH | None | https://reporter.nih.gov/quic… | View |