@misc{10481/80072,
year = {2022},
month = {12},
url = {https://hdl.handle.net/10481/80072},
abstract = {Exclusive breastfeeding is recommended for the first six months of life to promote adequate
infant growth and development, and to reduce infant morbidity and mortality. However, whenever
some mothers are not able to breastfeed their infants, infant formulas mimicking human milk are
needed, and the safety and efficacy of each formula should be tested. Here, we report the results of
a multicenter, randomized, blinded, controlled clinical trial that aimed to evaluate a novel starting
formula on weight gain and body composition of infants up to 6 and 12 months, as well as safety and
tolerability. For the intervention period, infants were divided into three groups: group 1 received
formula 1 (Nutribén® Innova 1 (Alter Farmacia S.A., Madrid, Spain) or INN (n = 70)), with a lower
amount of protein, a lower casein to whey protein ratio by increasing the content of  -lactalbumin,
and a double amount of docosahexaenoic acid/arachidonic acid than the standard formula; it also
contained a thermally inactivated postbiotic (Bifidobacterium animalis subsp. lactis, BPL1TM HT).
Group 2 received the standard formula or formula 2 (Nutriben® Natal (Alter Farmacia S.A., Madrid,
Spain) or STD (n = 70)) and the third group was exclusively breastfed for exploratory analysis and
used as a reference (BFD group (n = 70)). During the study, visits were made at 21 days and 2, 4, 6, and 12 months of age. Weight gain was higher in both formula groups than in the BFD group at 6
and 12 months, whereas no differences were found between STD and INN groups either at 6 or at
12 months. Likewise, body mass index was higher in infants fed the two formulas compared with
the BFD group. Regarding body composition, length, head circumference and tricipital/subscapular
skinfolds were alike between groups. The INN formula was considered safe as weight gain and
body composition were within the normal limits, according to WHO standards. The BFD group
exhibited more liquid consistency in the stools compared to both formula groups. All groups showed
similar digestive tolerance and infant behavior. However, a higher frequency of gastrointestinal
symptoms was reported by the STD formula group (n = 291), followed by the INN formula (n = 282),
and the BFD groups (n = 227). There were fewer respiratory, thoracic, and mediastinal disorders
among BFD children. Additionally, infants receiving the INN formula experienced significantly
fewer general disorders and disturbances than those receiving the STD formula. Indeed, atopic
dermatitis, bronchitis, and bronchiolitis were significantly more prevalent among infants who were
fed the STD formula compared to those fed the INN formula or breastfed. To evaluate whether there
were significant differences between formula treatments, beyond growth parameters, it would seem
necessary to examine more precise health biomarkers and to carry out long-term longitudinal studies.},
organization = {Alter Farmacia S.A},
publisher = {MDPI},
keywords = {Arachidonic acid},
keywords = {alpha-lactalbumin},
keywords = {Bifidobacterium animalis subsp. lactis},
keywords = {BPL1TM},
keywords = {Body composition},
keywords = {Docosahexaenoic acid},
keywords = {Infant formula},
keywords = {Postbiotics},
keywords = {Protein},
keywords = {Safety},
title = {Effects of a Novel Infant Formula on Weight Gain, Body Composition, Safety and Tolerability to Infants: The INNOVA 2020 Study},
doi = {10.3390/nu15010147},
author = {Plaza Díaz, Julio and Ruiz Ojeda, Francisco Javier and Gil Hernández, Ángel},
}