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

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 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.

Innova 2020: A Follow-Up Study of the Fecal Microbiota of Infants Using a Novel Infant Formula between 6 Months and 12 Months of Age

“…In our study, the main comparison was made using the BF group. A detailed description of the effects of the different groups on weight gain, body composition, safety, and tolerability has been provided elsewhere [ 24 ].…”

“…Based on the Rivera-Pinto approach [ 28 ], we observed that the INN formula group has a higher AUC value than the BF group, all of which are compared using the ROC curve. The safety of the INN formula group and its impact on the body composition group was described elsewhere [ 24 , 25 ]. It is believed that the modifications made to the INN formula are intended to produce a similar effect to breastfeeding.…”

“…The health authorities were also permitted to inspect the trial. Ruiz-Ojeda et al, 2022, and Plaza-Diaz et al, 2023, provide further details regarding the study protocol [ 24 , 25 ].…”

“…Our previous article reported the results of a multicenter, randomized, blinded, controlled clinical trial examining the effects of a novel starting formula on weight gain and body composition in infants up to 6 and 12 months as well as its safety and tolerability compared to infants fed a standard formula (STD) and a reference breastfed (BF) infant group (INNOVA 2020 Study) [ 24 ]. The design and methodology were previously registered with Clinicaltrial.gov (NCT05303077) on 31 March 2022 and were updated and published on 7 April 2022 [ 25 ].…”

“…However, infants who received the INN formula experienced significantly fewer general disorders and disturbances than infants who received the STD formula. The STD formula group was significantly more likely to cause bronchiolitis, atopic dermatitis, and bronchiolitis [ 24 ].…”