Overview

This trial is active, not recruiting.

Condition development
Treatment type of formula
Sponsor Monell Chemical Senses Center
Collaborator University of Delaware
Start date October 2012
End date December 2017
Trial size 144 participants
Trial identifier NCT01700205, HD072307

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, outcomes assessor)
Arm
(Active Comparator)
infant is randomized to feed standard cow milk formula during first year of life
type of formula cow milk formula (CMF)
infant formula
(Experimental)
infant is randomized to feed extensively hydrolyzed infant formula during first year of life
type of formula cow milk formula (CMF)
infant formula

Primary Outcomes

Measure
Growth and energy balance
time frame: Infant age 2 weeks to 18 months

Secondary Outcomes

Measure
Intake and feeding behaviors
time frame: Infant age 2 weeks to 18 months
Genotype
time frame: 2wks-18 months

Eligibility Criteria

Male or female participants up to 3 weeks old.

Inclusion Criteria 1. A healthy, term (≥37 and ≤42 week gestation at birth), singleton infant. 2. Birth weight between 2500 - 4500 grams. 3. At the time of enrollment, infant must be ≤14 days old (Date of birth=day 0). 4. Mother must be 18 years or older. 5. 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. Exclusion Criteria 1. Mother had gestational diabetes during pregnancy 2. Infant has condition requiring infant feedings other than feeding cow milk formula from a bottle. 3. Infant has major congenital malformations (i.e. cleft palate, hemangiomas, extremity malformation). 4. Infant has suspected or documented systemic or congenital infections (e.g., human immunodeficiency virus, cytomegalovirus). 5. 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. 6. Dyad be the relative (son, daughter, niece, nephew, cousin, aunt, uncle, sibling) of ancillary personnel connected with the study.

Additional Information

Official title Impact of Diet Composition on Energy Balance and Satiety During Infancy
Principal investigator Julie A Mennella, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Monell Chemical Senses Center.