N/A
N=113
Effect of Infant Formula on Energy Balance
Development
Bottom Line
View on ClinicalTrials.gov: NCT01700205 ↗Enrolled (actual)
113
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Growth, Weight for Length (WLZ) Z Scores — -0.26; -0.12; -0.12; 0.13 Z score — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Type of Formula (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Monell Chemical Senses Center
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Growth, Weight for Length (WLZ) Z Scores |
-0.26; -0.12; -0.12; 0.13; 0.24; -0.17 | <0.05 sig |
| PRIMARY Growth, Weight for Age (WAZ) Z Score |
-0.36; -0.25; -0.41; -0.28; -0.38; -0.61 | 0.001 sig |
| PRIMARY Growth: Length for Age (LAZ) Z Scores |
-0.49; -0.46; -0.56; 0.59; -0.55; -0.48 | 0.32 |
| PRIMARY Energy Balance: Energy Intake From Infant Formula and Other Sources |
466; 383; 0; 0; 628; 596 | <0.05 sig |
| PRIMARY Energy Balance: Sleeping Energy Expenditure (SEE) |
206; 201; 329; 321; 507; 509 | 0.72 |
| PRIMARY Energy Balance: Total Energy Expenditure (TEE) |
283; 243; 488; 444; 859; 858 | 0.72 |
| PRIMARY Energy Balance: Energy Loss in Stools |
22.3; 34.9; 20.7; 17.0; 27.1; 33.8 | 0.02 sig |
| SECONDARY Feeding Behaviors, Maternal Perceptions |
3.1; 3.0; 2.8; 2.6; 2.2; 2.4 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01700205). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.