A Neurocognitive and Immunological Study of a New Formula for Healthy Infants

Conditions

Infant Development

Keywords

Infant Formula, Cognition, Neurodevelopment, Immunity, Microbiota

Brief summary

To compare the neurocognitive and immunological development in infants fed a new infant formula with functional specific nutrients to infants consuming a standard infant formula.

Estefanía Diéguez, Ana Nieto-Ruíz, Cristina Martín-Pérez, Natalia Sepúlveda-Valbuena, Florian Herrmann et al. (11 authors)

Frontiers in Nutrition2022-10-126 citations

10.3389/fnut.2022.935740

A synbiotics, long chain polyunsaturated fatty acids, and milk fat globule membranes supplemented formula modulates microbiota maturation and neurodevelopment

Tomás Cerdó, Alicia Ruíz, Inmaculada Acuña, Ana Nieto-Ruíz, Estefanía Diéguez et al. (15 authors)

Clinical Nutrition2022-05-2326 citations

10.1016/j.clnu.2022.05.013

Infant Formula Supplemented With Milk Fat Globule Membrane, Long-Chain Polyunsaturated Fatty Acids, and Synbiotics Is Associated With Neurocognitive Function and Brain Structure of Healthy Children Aged 6 Years: The COGNIS Study

Ana Nieto-Ruíz, José Antonio García-Santos, Juan Verdejo‐Román, Estefanía Diéguez, Natalia Sepúlveda-Valbuena et al. (15 authors)

Frontiers in Nutrition2022-03-0929 citations

10.3389/fnut.2022.820224

Growth patterns and breast milk/infant formula energetic efficiency in healthy infants up to 18 months of life: the COGNIS study

Natalia Sepúlveda-Valbuena, Ana Nieto-Ruiz, Estefanía Diéguez, Florian Herrmann, Mireia Escudero-Marín et al. (11 authors)

British Journal Of Nutrition2021-02-1912 citations

10.1017/s000711452100057x

Interventions

DIETARY_SUPPLEMENTNew infant formula

New infant formula

DIETARY_SUPPLEMENTStandard infant formula

Standard infant formula

DIETARY_SUPPLEMENTBreastfeeding

Exclusive breastfeeding or less tan 25% formula intake

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

1 Days to 60 Days

Healthy volunteers

Yes

Inclusion criteria

* Full-term newborns (\>37 weeks and \<41 weeks gestation) * Adequate birth weight for his gestational age (between 3-97 percentiles) * Inclusion age: from 0 to 2 months (60 days) in the formula fed groups * Inclusion age: 2-6 months (180 days) in the breastfeeding group * Maximum 30 days of exclusive breastfeeding in the formula fed groups * From 30 days on, exclusive or \>70% infant formula in the formula fed groups * Normal Apgar score: 7-10 * Umbilical pH ≥ of 7.10 * Availability to continue during the whole study period * Informed consent signed ( parent/legal representative)

Exclusion criteria

* Participating in other studies. * Nervous system disorders (hydrocephalic, perinatal hypoxia, intraventricular hemorrhage, neonatal meningitis, septic shock, West Sd...). * Gastrointestinal disorders (cow's milk protein allergy, lactose intolerance) * Mother's disease history or during pregnancy: neurological and metabolic diseases, diabetes mellitus type 1, hypothyroidism, undernutrition, infections TORCH complex. * Mothers receiving anxiolytic or antidepressant treatment during pregnancy or other potentially harmful drug treatments for infants' neurodevelopment. * Infant's family who in the investigators assessment cannot be expected to comply with the protocol.

Design outcomes

Primary

Measure	Time frame	Description
Neurocognitive Development at 6 years	At 6 years of age	Functional Magnetic Resonance Image
Neurocognitive Development	At 2nd, 3rd, 4th, 6th, 12th,18th, 30 th months.	Differences in neurocognitive development inter and intragroup evaluated by visual evoked potential test, general movements test, BAYLEY'S III test, MacArthur test, behavior assessment and cognitive evoked potential test (EEG/ERP).
Neurocognitive Development at 4 and 6 years	At 4 and 6 years of age	Differences in neurocognitive development evaluated by Computarized battery for neuropsychological evaluation of children, Kaufman Brief Intellligence Test, Language test of Navarre,functional exploration, behavior assessment, questionnaires and cognitive evoked potential test (EEG/ERP).

Secondary

Measure	Time frame	Description
Incidence of infections	At 2nd, 3rd, 4th, 6th, 12th,18th month; age 2.5, 4 and 6.	Number of infections reported.
Immunoglobulin A secretor (IgAs) levels	At 3rd, 6th, 12th,18th month, and 4 years old.	Inter and intragroup differences measured by saliva samples analysis.
Impact on microbiota	At 3rd, 6th, 12th and 18th months; 4 and 6 years of age.	Changes in microbiota composition measured by real-time polymerase chain reaction (RT-PCR) in faeces.
Cardiovascular factors	At 4 and 6 years old	Blood pressure measurement
Glucose monitoring	At 6 years old	Urine metabolomic analysis
Long Chain Polyunsaturated Fatty Acids (LC-PUFAS) levels	At 3rd, 6th, 12th,18th months; 2.5, 4 and 6 years of age.	Differences in LC-PUFAS levels inter and intragroup evaluated by oral mucosa samples analysis.
Formula Tolerability	At 2nd, 3rd, 4th, 6th, 12th and 18th months.	Evaluation of gastrointestinal symptoms and sleep disorders amongst groups.
Growth	At 2nd, 3rd, 4th, 6th, 12th,18th month; age 2.5, 4 and 6.	Differences in growth parameters (weight, length, BMI, skin folds, perimeters and z-scores) between groups.

Other

Measure	Time frame	Description
Dietary assessment	At 6th, 12th and 18th months; 2.5, 4 and 6 years.	Food frequency questionnaires and 24 h food recalls.

Countries

Spain

Outcome results

None listed