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Efficacy of a Nutrient Blend in Improving Neurocognitive and Behavioral Outcomes in Infants: a Randomized, Controlled, Intervention Study

Infant Nutrition Clinical Trial

Official title:
Efficacy of a Nutrient Blend Comprised of Specific Nutrients in Improving Neurocognitive and Behavioural Outcomes in Infants: a Randomized, Controlled, Intervention Study

Clinical Trial Summary

The purpose of this study is to demonstrate the efficacy of the nutrient blend in a starter infant formula (IF) and follow up infant formula (FUF) in improving the neurocognitive and behavioural outcomes among formula-fed infants randomized to the experimental formula (EF) versus the control formula (CF).

Clinical Trial Description

This is a prospective, randomized, controlled, double-blind, 2-arm parallel-group clinical trial in the Philippines. Subjects will be recruited from a single centre; in case of insufficient recruitment, more sites will be added to the study. The clinical trial is composed of two parts: a double-blind interventional period and a follow-up period. The first period is the double-blind intervention phase from enrolment (V1) until age 12 months (V5). The intervention will be provided only during this double-blind phase. The second period is a non-interventional follow-up period from age 12 months until age 24 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05310396
Study type Interventional
Source Société des Produits Nestlé (SPN)
Contact Elvira M Estorninos, MD
Phone +639178259302
Email elvie_323@yahoo.com
Status Recruiting
Phase N/A
Start date October 7, 2022
Completion date November 2025
View Details
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