Effect of Infant Formula on Energy Balance

Completed · Not applicable

Conditions studied: Development

In brief

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.

Key facts

Study ID

NCT01700205

Run by

Monell Chemical Senses Center

People needed

113

Starts

2012-11-02

Expected to finish

2016-09-21

Last updated by the study team

2019-11-22

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Monell Chemical Senses Center — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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