Infant NutritionNCT05310396
Efficacy of a Nutrient Blend in Improving Neurocognitive and Behavioral Outcomes in Infants: a Randomized, Controlled, Intervention Study
A study testing Experimental formula in people with Infant Nutrition and Cognitive Development, run by Société des Produits Nestlé (SPN) at 1 site in Philippines.
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). Read more about this study
- Who is it for?
- Ages 6 to 8 weeksHealthy volunteers can take part
- Conditions the study is for
- Infant Nutrition, Cognitive Development
- What is being tested?
- Experimental formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 sitePhilippines
- Study dates
- 7 Oct 2022to 29 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 8 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
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- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Infant Nutrition, Cognitive Development
- Being tested
- Experimental formula, Control Formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental formulaOther
Cow's milk-based infant formula with a specific blend of nutrients at pre-defined levels
Control FormulaOther
Cow's milk-based infant formula with standard nutritional composition
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Control Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (11)
Infant Global developmental status in all domains of the Bayley Scale of Infant Development, 4th Edition
Infant Language, motor, socio-emotional, adaptive behaviour, and cognitive scores will be assessed
Measured: 6 months, 9 months, 12 months, and 24 months
Infant Visual attention
Developmental status of infants' visual attention will be assessed using the infant Gap-Overlap task
Measured: 4 months, 6 months, 9 months, and 12 months
Infant Visual learning
Infant's quality of attention will be assessed using the infant visual habituation task as augmented with heart rate
Measured: 4 months, 6 months, 9 months, and 12 months
Early language development
Assessed using the MacArthur-Bates Communicative Development Inventories
Measured: Words and Gestures (long form) at 12 months and Words and Sentences (long form) at 24 months
Working memory and inhibitory control
Assessed using the A-not-B Invisible Displacement Task
Measured: 24 months
Behavioral manifestations of executive function
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
Measured: 24 months
Infant temperament
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)
Measured: 1.5-2 months, 6 months, and 12 months
Child temperament
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).
Measured: 24 months
Infant sleep
Infant daytime and night-time sleep patterns, parent perception, and sleep-related behaviours will be assessed using the Brief Infant Sleep Questionnaire
Measured: 1.5-2 months, 6 months, 12 months, and 24 months
Infant fecal microbiota
Overall fecal microbiota composition, diversity, microbiota community types will be assessed using next generation sequencing (NGS) technology
Measured: 1.5-2 months (but before starting study formula), and just prior to 6 months, and 12 months
Infant immune and gut health biomarkers
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
Measured: 1.5-2 months (but before starting study formula), 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start7 Oct 2022
- Primary completion18 Jul 2025
- Study completion29 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant NutritionStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elvira M Estorninos, MD, Principal investigator, Las Pinas Doctors Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05310396
- Sponsor's protocol ID
- 20.26.INF
- Status last verified
- Sep 2026
- First submitted
- 4 Jan 2022
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Nutrient Blend Comprised of Specific Nutrients in Improving Neurocognitive and Behavioural Outcomes in Infants: a Randomized, Controlled, Intervention Study
- ClinicalTrials.gov ID
- NCT05310396
- Acronym / sponsor ID
- 20.26.INF
- Conditions
- Infant Nutrition, Cognitive Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 7 Oct 2022 (actual)
- Primary completion
- 18 Jul 2025 (actual)
- Study completion
- 29 Sep 2025 (actual)
- First posted
- 4 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Powdered cow's milk-based infant formula containing uniquely processed whey protein | Experimental | Other: Experimental formulaStarter and follow up formula containing combination of an HMO blend, myelin nutrient blend, and MOS |
| Powdered infant fortified cow's milk | Active comparator | Other: Control FormulaStandard Starter and follow up formula without added HMOs or MOS containing lower levels of myelin nutrients |
Who may qualify
- Ages
- 6 to 8 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental formulaCow's milk-based infant formula with a specific blend of nutrients at pre-defined levels | Other | Powdered cow's milk-based infant formula containing uniquely processed whey protein |
| Control FormulaCow's milk-based infant formula with standard nutritional composition | Other | Powdered infant fortified cow's milk |
Primary outcome
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
11 secondary outcomes
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 Visual attention
Time frame: 4 months, 6 months, 9 months, and 12 months
Infant Visual learning
Time frame: 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
Working memory and inhibitory control
Time frame: 24 months
Behavioral manifestations of executive function
Time frame: 24 months
Infant temperament
Time frame: 1.5-2 months, 6 months, and 12 months
Child temperament
Time frame: 24 months
Infant sleep
Time frame: 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
Infant immune and gut health biomarkers
Time frame: 1.5-2 months (but before starting study formula), 6 months, and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elvira M Estorninos, MD principal investigator
Las Pinas Doctors Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental formula in people with Infant Nutrition and Cognitive Development, run by Société des Produits Nestlé (SPN) at 1 site in Philippines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scores on the Cognitive subscale of the Bayley Scale of Infant Development, 4th Edition (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.