Effects of a Novel Infant Formula on Weight Gain, Body Composition, Safety and Tolerability to Infants: The INNOVA 2020 Study

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 s...

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Published in:	Nutrients Vol. 15; no. 1; p. 147
Main Authors:	Plaza-Diaz, Julio, Ruiz-Ojeda, Francisco Javier, Morales, Javier, de la Torre, Ana Isabel Cristina, García-García, Antonio, de Prado, Carlos Nuñez, Coronel-Rodríguez, Cristóbal, Crespo, Cyntia, Ortega, Eduardo, Martín-Pérez, Esther, Ferreira, Fernando, García-Ron, Gema, Galicia, Ignacio, Santos-García-Cuéllar, María Teresa, Maroto, Marcos, Ruiz, Paola, Martín-Molina, Raquel, Viver-Gómez, Susana, Gil, Angel
Format:	Journal Article
Language:	English
Published:	Switzerland MDPI AG 28-12-2022 MDPI
Subjects:	Age Arachidonic acid Atopic dermatitis Babies Baby foods Bifidobacterium animalis subsp. lactis Body Composition Body mass Body mass index Body size Body weight gain Bottle Feeding BPL1TM Breast Feeding Breast milk Breastfeeding & lactation Bronchitis Bronchopneumonia Casein Child Clinical trials Dermatitis Design Development Diarrhea Docosahexaenoic acid Evaluation Fatty acids Female Gastrointestinal symptoms Health aspects Humans Infant Infant Formula Infant formulas Infants Intelligence tests Lactalbumin Longitudinal studies Metabolism Morbidity Obesity Pediatric research Personal information Prebiotics Probiotics Proteins Regulation Safety Thorax Weight Gain Whey protein α-lactalbumin Spain arachidonic acid body composition postbiotics infant formula α-lactalbumin BPL1TM docosahexaenoic acid safety protein Bifidobacterium animalis subsp. lactis
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Summary:	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 ( = 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 ( subsp. , BPL1 HT). Group 2 received the standard formula or formula 2 (Nutriben Natal (Alter Farmacia S.A., Madrid, Spain) or STD ( = 70)) and the third group was exclusively breastfed for exploratory analysis and used as a reference (BFD group ( = 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 ( = 291), followed by the INN formula ( = 282), and the BFD groups ( = 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.
Bibliography:	ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Undefined-1 ObjectType-Feature-3 content type line 23 These authors contributed equally to this work.
ISSN:	2072-6643 2072-6643
DOI:	10.3390/nu15010147