Effects of Different ARA Formulations of Infant Formula on Fatty Acid Status, Immune Markers and Infection Rates in Infants

Study Overview
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Brief Summary
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The clinical trial will investigate the effect of different formulations of ARA + 0.4% DHA in infant formula on plasma fatty acid status in healthy 6 months old infants supplemented for 6 months. A 6-month follow on phase will provide additional efficacy (e.g. infection rates, immune markers) and safety information in these 12-18 month old infants.

Detailed Description
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This study is a randomized, double-blind, parallel-group study of 0% ARA +0.4% DHA or 0.76% ARA +0.4% DHA supplemented infant formula provided to 6 months old healthy infants for 6 months. Infants will have been breast-fed or formula-fed prior to enrollment. The difference in total plasma fatty acid ARA levels between the two groups at 6 months of supplementation will be measured. Parents will be asked about the infant's current daily diet (fatty acid intakes calculated via 24 hour recalls). All completed infants will be enrolled into a 6 month extension period (non-supplemented) to collect additional measures of efficacy (i.e. infections and illnesses, immune markers) and safety out to 18 months of age.

Official Title
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EFFECTS OF DIFFERENT ARA FORMULATIONS OF INFANT FORMULA ON FATTY ACID STATUS, IMMUNE MARKERS AND INFECTION RATES IN INFANTS

Conditions
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Healthy Infants

Intervention / Treatment
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* Dietary Supplement: combination ARA + DHA
* Dietary Supplement: DHA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: singleton infants, parent of legal age to consent, willing to feed the child the assigned study formula for the treatment duration, parent agrees to scheduled blood draws Exclusion Criteria: exclusively breastfed or formula-fed beyond 6 months, difficulty swallowing or other congenital malformation or metabolic anomaly, taking omega-3 (supplemented) foods, mother had gestational diabetes or is Type II diabetic, born at <37 weeks gestational age, participating in another study

Ages Eligible for Study
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Minimum Age: 22 Weeks
Maximum Age: 26 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: combination ARA+ DHA<br>combination 0.76% ARA+ 0.4% DHA in infant formula per day | Dietary Supplement: combination ARA + DHA<br>* combination ARA + DHA supplemented infant formula<br>* Other names: infant formula;|
| Experimental: DHA<br>0% ARA +0.4% DHA in infant formula per day | Dietary Supplement: DHA<br>* DHA supplemented infant formula<br>* Other names: infant formula;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total plasma fatty acid ARA levels | difference in total plasma fatty acid ARA levels between the two groups at 6 months of supplementation | 6 months of supplementation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of infections | record number, type and duration of infections | 6 months of supplementation | 
| weight gain | differences between groups in weight gain (kg/d) | 6 months of supplementation | 
| length gain | differences between groups in length gain (cm/d) | 6 months of supplementation | 
| head circumference | differences between groups in head circumference (cm/d) | 6 months of supplementation | 
| dietary intake of ARA | 24 hour recall questionnaire | 6 months of supplementation | 
| plasma levels of immune markers | cytokines and T cells levels in plasma will be measured | 6 months of supplementation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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arachidonic, docosahexaenoic acid, infant formula