Focus: Nutritional Requirements for Infants
Conditions
Keywords
nutrient, nutrition, arachidonic acid, essential fatty acids
Brief summary
The immune system of newborn infants is immature with low activity of both innate and acquired immune reactions. Early nutrition has an impact on early immune responses. Dietary fatty acids are one nutritional factor noted to play a role in immune function. The omega-6 long-chain polyunsaturated fatty acid, ARA (Arachidonic acid) and the omega-3 fatty acid, DHA (docosahexaenoic acid) are found naturally in breastmilk and some infant formulas. The balance or relative amounts of ARA and DHA have been associated with immune response. Some commercial infant formula contains both ARA and DHA. However, the optimal balance of ARA and DHA has not been determined with respect to immune function. This study will assess two levels of ARA and the impact on immune response in healthy, term infants and whether genes that influence essential fatty acid metabolism alter the nutritional requirement of infants.
Interventions
DIETARY_SUPPLEMENTArachidonic acid (25 mg/100 kcal )
DIETARY_SUPPLEMENTArachidonic acid (34 mg/100 kcal)
DIETARY_SUPPLEMENTPlacebo
10 weeks exclusive infant formula feeding (without supplemental arachidonic acid).
Sponsors
Mead Johnson Nutrition
University of Alberta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
14 Days to 21 Days
Healthy volunteers
Yes
Inclusion criteria
* healthy term infants * birth weight, length and head circumference between the 5th and 95th percentile for gestational age (according to the National Center for Health Statistics growth charts) * receiving \>80% for their intake by mouth from commercial infant formula * low-risk for allergy based on a negative family history.
Exclusion criteria
* corticosteroid use * red cell or plasma transfusions * IV lipid emulsions prior to study entry * major congenital malformations * systemic or congenital infection * significant neonatal morbidity * maternal autoimmune disorders * acute illness precluding oral feedings or conditions requiring feedings other than standard formula
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Antigen-presenting B Cells | 10 weeks |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 34 mg/100 kcal Arachidonic Acid 10 weeks exclusive feeding with infant formula containing 34 mg/100 kcal of arachidonic acid | 30 |
| 25 mg/100 kcal Arachidonic Acid 10 weeks exclusive feeding with infant formula containing 25 mg/100 kcal of arachidonic acid | 30 |
| Infant Formula Without Arachidonic Acid 10 weeks exclusive infant formula feeding (without supplemental arachidonic acid). | 29 |
| Total | 89 |
Baseline characteristics
| Characteristic | 34 mg/100 kcal Arachidonic Acid | 25 mg/100 kcal Arachidonic Acid | Infant Formula Without Arachidonic Acid | Total |
|---|---|---|---|---|
| Age, Continuous | 16.8 days STANDARD_DEVIATION 3.8 | 16.5 days STANDARD_DEVIATION 3.8 | 17.8 days STANDARD_DEVIATION 4.4 | 17 days STANDARD_DEVIATION 1.2 |
| Region of Enrollment Canada | 30 participants | 30 participants | 29 participants | 89 participants |
| Sex: Female, Male Female | 15 Participants | 17 Participants | 16 Participants | 48 Participants |
| Sex: Female, Male Male | 15 Participants | 13 Participants | 13 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 30 | 7 / 30 | 3 / 29 |
| serious Total, serious adverse events | 1 / 30 | 0 / 30 | 0 / 29 |
Outcome results
Primary
Number of Antigen-presenting B Cells
Time frame: 10 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 34 mg/100 kcal Arachidonic Acid | Number of Antigen-presenting B Cells | 21.9 percentage of CD20+ B cells |
| 25 mg/100 kcal Arachidonic Acid | Number of Antigen-presenting B Cells | 22.8 percentage of CD20+ B cells |
| Infant Formula Without Arachidonic Acid | Number of Antigen-presenting B Cells | 25.1 percentage of CD20+ B cells |