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

Healthy Infants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03014115
• Other study ID #: 2015-1080
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Est. completion date: August 2019

Study information

• Verified date: January 2020
• Source: DSM Nutritional Products, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: August 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Weeks to 26 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Healthy Infants
• Infection

Intervention

Dietary Supplement:
• combination ARA + DHA
combination ARA + DHA supplemented infant formula
• DHA
DHA supplemented infant formula

Locations

Country	Name	City	State
Spain	Centro de Salud Aravaca	Madrid
Spain	Centro Salud Arganda del Rey	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
DSM Nutritional Products, Inc.	SynteractHCR

Country where clinical trial is conducted

Spain, 

Outcome

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