Infants
Conditions
Brief summary
This is a prospective, double blind, crossover study in healthy infants randomized to one of two study formulas. The trial will consist of two 21 day study feeding periods separated by a study washout period.
Interventions
OTHERStandard Milk-based Formula Containing Carotenoid
Fed ad libitum
OTHERInvestigational Milk-based Formula Containing Carotenoid
Fed ad libitum
Sponsors
Abbott Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
14 Days to 28 Days
Healthy volunteers
Yes
Inclusion criteria
* Infant is in good health * Infant is a singleton from a full term birth with a gestational age of 37-42 weeks * Infant's birth weight was \> 2490 g (\ 5 lbs 8 oz) * Infant is between 14 and 28 days of age * Parent(s) confirm intention to feed their infant the study product(s) as the sole source of nutrition for the duration of the study * Parent(s) confirm intention not to administer vitamin or mineral supplements, DHA and ARA supplements, solid foods/juices to their infant from enrollment through the duration of the study
Exclusion criteria
* An adverse maternal, fetal or infant medical history that has potential for effects on tolerance, growth, and/or development. * Infants using medications (including OTC), home remedies, herbal preparations, probiotics or rehydration fluids that might affect gastrointestinal (GI) tolerance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Carotenoid Concentration | Change from Baseline to end of Study Period A (~21 Days) | Plasma sample |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Carotenoid Concentration | Change from Baseline to end Study Periods A (~21 Days) and B (~21 Days) | Plasma sample |
Countries
United States
Outcome results
None listed