RT Journal Article
T1 Effects of a Novel Infant Formula on Weight Gain, Body Composition, Safety and Tolerability to Infants: The INNOVA 2020 Study.
A1 Plaza-Diaz, Julio
A1 Ruiz-Ojeda, Francisco Javier
A1 Morales, Javier
A1 de la Torre, Ana Isabel Cristina
A1 Garcia-Garcíi Antonio, 
A1 de Prado, Carlos Nuñez
A1 Coronel-Rodriguez, Cristobal
A1 Crespo, Cyntia
A1 Ortega, Eduardo
A1 Martin-Perez, Esther
A1 Ferreira, Fernando
A1 Garcia-Ron, Gema
A1 Galicia, Ignacio
A1 Santos-Garcia-Cuellar, Maria Teresa
A1 Maroto, Marcos
A1 Ruiz, Paola
A1 Martin-Molina, Raquel
A1 Viver-Gomez, Susana
A1 Gil, Angel
K1 BPL1TM
K1 Bifidobacterium animalis subsp. lactis
K1 arachidonic acid
K1 body composition
K1 docosahexaenoic acid
K1 infant formula
K1 postbiotics
K1 protein
K1 safety
K1 α-lactalbumin
AB 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 α-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.
PB MDPI AG
YR 2022
FD 2022-12-23
LK http://hdl.handle.net/10668/21526
UL http://hdl.handle.net/10668/21526
LA en
NO Plaza-Diaz J, Ruiz-Ojeda FJ, Morales J, de la Torre AIC, García-García A, de Prado CN, et al. Effects of a Novel Infant Formula on Weight Gain, Body Composition, Safety and Tolerability to Infants: The INNOVA 2020 Study. Nutrients. 2022 Dec 28;15(1):147.
DS RISalud
RD Apr 9, 2025