At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Assessment of Arachidonic Acid Supplementation in Infant Formula on the Immune Response of Infants
In Brief
A Phase 1 clinical trial evaluating Arachidonic acid (25 mg/100 kcal ), Arachidonic acid (34 mg/100 kcal), and 1 other intervention for Focus: Nutritional Requirements for Infants. Completed, enrolled 89 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
10 weeks exclusive infant formula feeding (without supplemental arachidonic acid).