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

September 9, 2026 updated by: Société des Produits Nestlé (SPN)

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Philippines
      • Las Piñas, Philippines, 1742
        • Las Piñas Doctors Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 month to 1 month (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Infants between 45 to 60 days of age at enrolment
  2. Infant's ≥ 37 completed weeks of gestation, with a birth weight of ≥ 2.5 kg and ≤ 4.5 kg and singleton born.
  3. Infants generally healthy at birth with an Apgar score ≥7 at 5 min
  4. 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
  5. Signed informed consent obtained for infant's and parents' participation in the study
  6. Parents of infant agree not to enrol infant in another interventional clinical research study while participating in this study
  7. Parent of infant agrees to provide to their infants the study formula and not replace it with another commercial formula.
  8. 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.
  9. Parent of infant can be contacted directly by telephone or email throughout the study.

Exclusion Criteria:

  1. 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.
  2. Evidence of feeding difficulties or formula intolerance, such as vomiting or poor intake, at time of randomization (at investigator discretion)
  3. Infants with known or suspected intolerance to cow milk infant formula or allergy
  4. 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
  5. Infants who have been adopted or are foster infants
  6. 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
  7. 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Powdered cow's milk-based infant formula containing uniquely processed whey protein
Starter and follow up formula containing combination of an HMO blend, myelin nutrient blend, and MOS
Other: Experimental formula
Cow's milk-based infant formula with a specific blend of nutrients at pre-defined levels
Active Comparator: Powdered infant fortified cow's milk
Standard Starter and follow up formula without added HMOs or MOS containing lower levels of myelin nutrients
Other: Control Formula
Cow's milk-based infant formula with standard nutritional composition

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Scores on the Cognitive subscale of the Bayley Scale of Infant Development, 4th Edition
Time Frame: 12 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Infant Global developmental status in all domains of the Bayley Scale of Infant Development, 4th Edition
Time Frame: 6 months, 9 months, 12 months, and 24 months
Infant Language, motor, socio-emotional, adaptive behaviour, and cognitive scores will be assessed
6 months, 9 months, 12 months, and 24 months
Infant Visual attention
Time Frame: 4 months, 6 months, 9 months, and 12 months
Developmental status of infants' visual attention will be assessed using the infant Gap-Overlap task
4 months, 6 months, 9 months, and 12 months
Infant Visual learning
Time Frame: 4 months, 6 months, 9 months, and 12 months
Infant's quality of attention will be assessed using the infant visual habituation task as augmented with heart rate
4 months, 6 months, 9 months, and 12 months
Early language development
Time Frame: Words and Gestures (long form) at 12 months and Words and Sentences (long form) at 24 months
Assessed using the MacArthur-Bates Communicative Development Inventories
Words and Gestures (long form) at 12 months and Words and Sentences (long form) at 24 months
Working memory and inhibitory control
Time Frame: 24 months
Assessed using the A-not-B Invisible Displacement Task
24 months
Behavioral manifestations of executive function
Time Frame: 24 months
Assessed using the Behavior Rating Inventory of Executive Function-Preschool version. The questionnaire consists of scales such as Inhibit, Shift, Emotional Control, working memory, plan and organize and Indexes such as Inhibitory Self control, Flexibility Index, Emergent metacognition index and Global Executive Composite. T scores are used to interpret the child's level of executive functioning on the BRIEF-P. scores provide information about a child's scores relative to the scores of children in the standardization sample
24 months
Infant temperament
Time Frame: 1.5-2 months, 6 months, and 12 months
Assessed using the Infant Behaviour Questionnaire Revised Short Form. The questionnaire assess dimensions of temperament along 14 scales on a 7-point Likert scale on behavior occurrence, with 1 being never and 7 being always (Activity level, Distress to limitations, Approach, Fear, Duration of orienting, smiling and laughter, vocal reactivity, Sadness, Perceptual sensitivity, High-intensity pleasure, Low-intensity pleasure, Cuddliness, Soothability, Falling Reactivity/Rate of Recovery From Distress)
1.5-2 months, 6 months, and 12 months
Child temperament
Time Frame: 24 months
Child temperament will be assessed using the Early Childhood Behavior Questionnaire- Short Form. The questionnaire measures 18 discrete traits embedded within three higher-order factors on a 7-point Likert scale on behavior occurrence, with 1 being never and 7 being always. Negative Affect (Discomfort, Fear, Frustration, Motor Activation, Sadness, Perceptual Sensitivity, Shyness, Soothability), Surgency (Impulsivity, Activity Level, High Intensity Pleasure, Sociability, Positive Anticipation), and Effortful Control (Inhibitory Control, Attention Shifting, Low Intensity Pleasure, Cuddliness, and Attentional Focusing).
24 months
Infant sleep
Time Frame: 1.5-2 months, 6 months, 12 months, and 24 months
Infant daytime and night-time sleep patterns, parent perception, and sleep-related behaviours will be assessed using the Brief Infant Sleep Questionnaire
1.5-2 months, 6 months, 12 months, and 24 months
Infant fecal microbiota
Time Frame: 1.5-2 months (but before starting study formula), and just prior to 6 months, and 12 months
Overall fecal microbiota composition, diversity, microbiota community types will be assessed using next generation sequencing (NGS) technology
1.5-2 months (but before starting study formula), and just prior to 6 months, and 12 months
Infant immune and gut health biomarkers
Time Frame: 1.5-2 months (but before starting study formula), 6 months, and 12 months
Fecal markers of immune and gut barrier, such as but no restricted to total secretory IgA (sIgA), lipocalin-2, calprotectin, and α-1-antitrypsin will be assessed by ELISA
1.5-2 months (but before starting study formula), 6 months, and 12 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Infant GI Tolerance
Time Frame: 1.5-2 months, 6 months, and 12 months
Assessed using Infant Gastrointestinal Symptom Questionnaire. The questionnaire comprises of 13 questions assessed on a 5-point Likert Scale with overall scores of 13 (best) to 65 (worst) for overall GI symptoms
1.5-2 months, 6 months, and 12 months
Toddler GI Tolerance
Time Frame: 24 months
Assessed using Toddler Gut Comfort Questionnaire. The questionnaire comprises of 10 questions assessed on a 6-point scale for frequency and severity, ranging from 1 (None or Not at all) to 6 (Always or Very strong).
24 months
Head circumference
Time Frame: 1.5-2 months, 4 months, 6 months, 9 months, 12 months and 24 months
Head circumference measured in cm
1.5-2 months, 4 months, 6 months, 9 months, 12 months and 24 months
Weight
Time Frame: 1.5-2 months, 4 months, 6 months, 9 months, 12 months and 24 months
Weight measured in grams
1.5-2 months, 4 months, 6 months, 9 months, 12 months and 24 months
Length/Height
Time Frame: 1.5-2 months, 4 months, 6 months, 9 months, 12 months and 24 months
Length/Height measured in cm
1.5-2 months, 4 months, 6 months, 9 months, 12 months and 24 months
BMI
Time Frame: 1.5-2 months, 4 months, 6 months, 9 months, 12 months and 24 months
Weight and height will be combined to report BMI in kg/m2
1.5-2 months, 4 months, 6 months, 9 months, 12 months and 24 months
Z-scores
Time Frame: 1.5-2 months, 4 months, 6 months, 9 months, 12 months and 24 months
Weight-for-age, height-for-age, weight-for-height, head circumference-for-age, BMI-for-age, weight and height velocity
1.5-2 months, 4 months, 6 months, 9 months, 12 months and 24 months
Incidence of infant illness and infection
Time Frame: 1.5-2 months, 13 months, and additionally at 23.8 months and 24 months
Collected as part of standard adverse events reporting for safety assessment including medication use and paper Infant Illness Diary continuously from enrolment until V5 (12 mo).
1.5-2 months, 13 months, and additionally at 23.8 months and 24 months
Formula intake adherence
Time Frame: Completed by the parent on a weekly basis beginning on the first day of intervention (1 day after V1 after the stool collection)
Assessed using Study Compliance Diary
Completed by the parent on a weekly basis beginning on the first day of intervention (1 day after V1 after the stool collection)
Infant dietary intake
Time Frame: Completed at home just prior to clinic visits at 6 months, 12 months and 24 months
Will be assessed using a 24-hour Dietary Recall completed by the parent / caregiver
Completed at home just prior to clinic visits at 6 months, 12 months and 24 months
Maternal Postpartum depression/ anxiety
Time Frame: 1.5-2 months and 4 months
Assessed using an Edinburgh Postnatal Depression Scale. The questionnaire comprises of 10 questions. Responses are scored 0, 1, 2 and 3 based on the seriousness of the symptom. The total score is obtained by adding together the scores for each of the 10 items. Scores above 12 or 13 are likely to be indicative of possible depression
1.5-2 months and 4 months
Parenting Stress
Time Frame: 1.5-2 months, 6 months, 12 months and 24 months
Assessed using a Parenting Stress Index-Short Form. The questionnaire comprises of thirty-six items divided into three domains: Parental Distress (PD), Parent-Child Dysfunctional Interaction (P-CDI), and Difficult Child (DC), which combine to form a Total Stress scale. Each subscale consists of 12 items rated from 1 (strongly disagree) to 5 (strongly agree), with subscales scores ranging from 12 to 60. A Total score is calculated by summing the three subscales scores, ranging from 36 to 180. Scores of 90 or above may indicate a clinical level of stress.
1.5-2 months, 6 months, 12 months and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Société des Produits Nestlé (SPN)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Elvira M Estorninos, MD, Las Piñas Doctors Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 7, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 18, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 29, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 4, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20.26.INF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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