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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Infants
• Intervention / Treatment: Dietary supplement: combination ARA + DHA; Dietary supplement: DHA

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain
    • Centro de Salud Aravaca
  • Madrid, Spain
    • Centro Salud Arganda del Rey

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 5 months (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: combination ARA+ DHA; combination 0.76% ARA+ 0.4% DHA in infant formula per day	Dietary supplement: combination ARA + DHA; combination ARA + DHA supplemented infant formula; Other Names: infant formula
EXPERIMENTAL: DHA; 0% ARA +0.4% DHA in infant formula per day	Dietary supplement: DHA; DHA supplemented infant formula; Other Names: infant formula

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: DSM Nutritional Products, Inc.
• Collaborators: SynteractHCR
• Investigators: Principal Investigator: Ascension Marcos, PhD, Instituto de Ciencia y Tecnología de Alimentos y Nutrición

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (ACTUAL): May 1, 2019
• Study Completion (ACTUAL): August 1, 2019

Study Registration Dates

• First Submitted: January 3, 2017
• First Submitted That Met QC Criteria: January 5, 2017
• First Posted (ESTIMATE): January 9, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 14, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: docosahexaenoic acid; infant formula; arachidonic
• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: 2015-1080

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO