Clinical trial NCT02094547: A Neurocognitive and Immunological Study of a New Formula for Healthy Infants
Official title: Evaluación Del Efecto de Una Nueva fórmula Infantil Con Ingredientes específicos Sobre el Desarrollo Neurocognitivo e inmunológico en Lactantes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infant Development
Keywords: Infant Formula
Cognition
Neurodevelopment
Immunity
Microbiota
Lead sponsor: Laboratorios Ordesa
Sponsor class: INDUSTRY
First posted: 2014-03-24
Enrollment: 220
Sex: ALL
Minimum age (years): 1
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Neurocognitive Development
timeFrame: At 2nd, 3rd, 4th, 6th, 12th,18th, 30 th months.
measure: Neurocognitive Development at 4 and 6 years
timeFrame: At 4 and 6 years of age
measure: Neurocognitive Development at 6 years
timeFrame: At 6 years of age
Secondary outcomes:
measure: Formula Tolerability
timeFrame: At 2nd, 3rd, 4th, 6th, 12th and 18th months.
measure: Growth
timeFrame: At 2nd, 3rd, 4th, 6th, 12th,18th month; age 2.5, 4 and 6.
measure: Incidence of infections
timeFrame: At 2nd, 3rd, 4th, 6th, 12th,18th month; age 2.5, 4 and 6.
measure: Immunoglobulin A secretor (IgAs) levels
timeFrame: At 3rd, 6th, 12th,18th month, and 4 years old.
measure: Impact on microbiota
timeFrame: At 3rd, 6th, 12th and 18th months; 4 and 6 years of age.
measure: Long Chain Polyunsaturated Fatty Acids (LC-PUFAS) levels
timeFrame: At 3rd, 6th, 12th,18th months; 2.5, 4 and 6 years of age.
measure: Cardiovascular factors
timeFrame: At 4 and 6 years old
measure: Glucose monitoring
timeFrame: At 6 years old
Other outcomes:
measure: Dietary assessment
timeFrame: At 6th, 12th and 18th months; 2.5, 4 and 6 years.
Locations:
city: Granada
country: Spain
facility: Facultad de Medicina
Study officials:
affiliation: Universidad de Granada
name: Cristina Campoy, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dieguez E, Nieto-Ruiz A, Martin-Perez C, Sepulveda-Valbuena N, Herrmann F, Jimenez J, De-Castellar R, Catena A, Garcia-Santos JA, Bermudez MG, Campoy C. Association study between hypothalamic functional connectivity, early nutrition, and glucose levels in healthy children aged 6 years: The COGNIS study follow-up. Front Nutr. 2022 Oct 12;9:935740. doi: 10.3389/fnut.2022.935740. eCollection 2022.
citation: Cerdo T, Ruiz A, Acuna I, Nieto-Ruiz A, Dieguez E, Sepulveda-Valbuena N, Escudero-Marin M, Garcia-Santos JA, Garcia-Ricobaraza M, Herrmann F, Moreno-Munoz JA, De Castellar R, Jimenez J, Suarez A, Campoy C. A synbiotics, long chain polyunsaturated fatty acids, and milk fat globule membranes supplemented formula modulates microbiota maturation and neurodevelopment. Clin Nutr. 2022 Aug;41(8):1697-1711. doi: 10.1016/j.clnu.2022.05.013. Epub 2022 May 23.
citation: Nieto-Ruiz A, Garcia-Santos JA, Verdejo-Roman J, Dieguez E, Sepulveda-Valbuena N, Herrmann F, Cerdo T, De-Castellar R, Jimenez J, Bermudez MG, Perez-Garcia M, Miranda MT, Lopez-Sabater MC, Catena A, Campoy C. 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. Front Nutr. 2022 Mar 9;9:820224. doi: 10.3389/fnut.2022.820224. eCollection 2022.
citation: Sepulveda-Valbuena N, Nieto-Ruiz A, Dieguez E, Herrmann F, Escudero-Marin M, De-Castellar R, Rodriguez-Palmero M, Miranda MT, Garcia-Santos JA, Bermudez MG, Campoy C. Growth patterns and breast milk/infant formula energetic efficiency in healthy infants up to 18 months of life: the COGNIS study. Br J Nutr. 2021 Dec 28;126(12):1809-1822. doi: 10.1017/S000711452100057X. Epub 2021 Feb 19.