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

NCT05310396 | Completed

• 1 other identifier: 20.26.INF
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Infant Nutrition; Cognitive Development

Outcome Measures

Primary Outcomes (1)

• Scores on the Cognitive subscale of the Bayley Scale of Infant Development, 4th Edition

  Change in the scores on the Cognitive subscale. The scores range from 40 to 160 and higher scores indicate a better cognitive outcome

  12 months

Secondary Outcomes (11)

• Infant Global developmental status in all domains of the Bayley Scale of Infant Development, 4th Edition

  6 months, 9 months, 12 months, and 24 months

• Infant Visual attention

  4 months, 6 months, 9 months, and 12 months

• Infant Visual learning

  4 months, 6 months, 9 months, and 12 months

• Early language development

  Words and Gestures (long form) at 12 months and Words and Sentences (long form) at 24 months

• Working memory and inhibitory control

  24 months

Other Outcomes (12)

• Infant GI Tolerance

  1.5-2 months, 6 months, and 12 months

• Toddler GI Tolerance

  24 months

• Head circumference

  1.5-2 months, 4 months, 6 months, 9 months, 12 months and 24 months

Study Arms (2)

Powdered cow's milk-based infant formula containing uniquely processed whey protein

EXPERIMENTAL

Starter and follow up formula containing combination of an HMO blend, myelin nutrient blend, and MOS

Other: Experimental formula

Powdered infant fortified cow's milk

ACTIVE COMPARATOR

Standard Starter and follow up formula without added HMOs or MOS containing lower levels of myelin nutrients

Other: Control Formula

Interventions

Experimental formula OTHER

Cow's milk-based infant formula with a specific blend of nutrients at pre-defined levels

Powdered cow's milk-based infant formula containing uniquely processed whey protein

Control Formula OTHER

Cow's milk-based infant formula with standard nutritional composition

Powdered infant fortified cow's milk

Eligibility Criteria

• Age: 6 Weeks - 8 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Infants between 45 to 60 days of age at enrolment
• Infant's ≥ 37 completed weeks of gestation, with a birth weight of ≥ 2.5 kg and ≤ 4.5 kg and singleton born.
• Infants generally healthy at birth with an Apgar score ≥7 at 5 min
• Exclusively formula fed for at least 14 days before randomization and the choice of formula feeding has been taken by the parents before the beginning of the trial
• Signed informed consent obtained for infant's and parents' participation in the study
• Parents of infant agree not to enrol infant in another interventional clinical research study while participating in this study
• Parent of infant agrees to provide to their infants the study formula and not replace it with another commercial formula.
• Parent of the infant is of legal age of consent, must understand the informed consent form and other study documents, willing and able to fulfil the requirements of the study protocol.
• Parent of infant can be contacted directly by telephone or email throughout the study.

You may not qualify if:

• History of underlying metabolic or chronic disease; congenital malformation; or any other condition which, in the opinion of the investigator, is likely to interfere with: the ability of the infant to ingest food, the normal growth and development of the infant, or the evaluation of the infant.
• Evidence of feeding difficulties or formula intolerance, such as vomiting or poor intake, at time of randomization (at investigator discretion)
• Infants with known or suspected intolerance to cow milk infant formula or allergy
• The infant is identified to have a chromosomal or major congenital anomaly or significant medical and/or genetic conditions that interferes with adequate functioning in daily life or likely to interfere with normal growth and development or with the normal maturation of visual or cognitive function (including visual/hearing impairment), known head or brain disease, injury such as microcephaly or macrocephaly, immunocompromised or suffered from significant illness, developmental delay or disability
• Infants who have been adopted or are foster infants
• Infants born to mothers with chronic illness, such as HIV disease, renal or hepatic disease, type 1 or type 2 diabetes, alcoholism, or substance abuse
• Presence of a first degree relative with neurologic or psychiatric diseases (e.g., attention deficit hyperactivity disorder, autism, behavioural problems, bipolar disorder, depression, intellectual disability, or schizophrenia).

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Las Piñas Doctors Hospital

Las Piñas, 1742, Philippines

Location

Study Officials

• Elvira M Estorninos, MD

  Las Pinas Doctors Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: April 4, 2022
• Study Start: October 7, 2022
• Primary Completion: July 18, 2025
• Study Completion: September 29, 2025
• Last Updated: December 4, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

PH (1)