Completed
GROImpact of Diet Composition on Energy Balance and Satiety During Infancy
What is being tested
Type of Formula
+ Type of Formula
Other
Who is being recruted
+11 Eligibility Criteria
How is the trial designed
Other Study
Interventional
Study Start: November 2012
Summary
Principal SponsorMonell Chemical Senses Center
Last updated: November 22, 2019
Sourced from a government-validated database.Claim as a partner
Study start date: November 2, 2012
Actual date on which the first participant was enrolled.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.
Principal SponsorMonell Chemical Senses Center
Last updated: November 22, 2019
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
113 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other Study
Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Any sex
Biological sex of participants that are eligible to enroll.Range of ages for which participants are eligible to join.
Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
5 inclusion criteria required to participate
A healthy, term ( >= 37 and <= 42 week gestation at birth), singleton infant
At the time of enrollment, infant must be <= 14 days old (Date of birth=day 0)
Birth weight between 2500 - 4500 grams
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
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6 exclusion criteria prevent from participating
Dyad be the relative (son, daughter, niece, nephew, cousin, aunt, uncle, sibling) of ancillary personnel connected with the study
Infant has condition requiring infant feedings other than feeding cow milk formula from a bottle
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
Infant has major congenital malformations (i.e. cleft palate, hemangiomas, extremity malformation)
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Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorInfants are randomized to feed standard cow milk formula during first year of life
Group II
ExperimentalInfants are randomized to feed extensively hydrolyzed infant formula during first year of life
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Monell Chemical Senses Center
Philadelphia, United StatesOpen Monell Chemical Senses Center in Google MapsCompletedOne Study Center