Effects of a novel infant formula on weight gain and body composition of infants: The INNOVA 2020 study
Authors: Plaza-Diaz Julio , Ruiz-Ojeda Francisco Javier , Morales Javier , de la Torre Ana Isabel Cristina , García-García Antonio , Nuñez de Prado Carlos , Coronel Cristóbal , Crespo Cyntia , Ortega Eduardo , Marín-Pérez Esther , Ferrerira Fernando , García-Ron Gema , Galicia Ignacio , Santos-García-Cuéllar María Teresa , Moroto Marcos , Ruiz Paola , Martín Raquel , Viver-Gómez Susana , Gil Angel 
Published: October 2022

Background

Breastmilk is the most appropriate food for infants and exclusive breastfeeding is highly recommended for the first six months of life to promote adequate growth and development and lower infant morbidity and mortality. Among the best-documented benefits of breastfeeding is the reduced risk of disease and infections such as pneumonia, diarrhea and acute otitis media. Nonetheless, there are situations in which the infant cannot be breastfed; therefore, it is essential to use an appropriately designed infant formula. As current infant formulas incorporate novel ingredients to partly mimic the composition of human milk, the safety and suitability of each specific infant formula should be tested by clinical evaluation in the target population. 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 (INNOVA 2020 study), as well as safety and tolerability. The complete protocol of this study has been previously issued.

Study design

210 infants (70/group) were enrolled in the study, and completed the intervention until 12 months of age. For the intervention period, infants were divided into three groups: group 1 received the formula 1 (Nutribén® Innova1 or INN), with a lower amount of protein, and enriched in α-lactalbumin protein, and with a double amount of docosahexaenoic acid (DHA)/ arachidonic acid (ARA) than the standard formula; it also contained a thermally inactivated postbiotic (Bifidobacterium animalissubsp.lactis, BPL1™ HT). Group 2 received the standard formula or formula 2 (Nutriben® Natal or STD) and the third group was exclusively breastfed for exploratory analysis and used as a reference (BFD group). During the study, visits were made at 21 days, 2, 4, 6, and 12 months of age, with ± 3 days for the visit at 21 days of age, ± 1 week for the visit at 2 months, and ± 2 weeks for the others. During the first 6 months of the study, the infants were only supplied with the starting formula or natural breastfeeding.

Results

The primary outcome, 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 neither at 6 nor at 12 months. Likewise, BMI 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 (GI) 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 INN formula or breastfed. To evaluate whether there are 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.

Clinical Trial Registration

The trial was registered withClinicaltrial.gov(NCT05303077) on March 31, 2022, and lastly updated on April 7, 2022.