A multicenter, randomized, blinded, controlled clinical trial investigating the effect of a novel infant formula on the body composition of infants: INNOVA 2020 study protocol

Background Breastmilk is the ideal food for infants and exclusive breastfeeding is recommended. In the clinical trial aimed to evaluate a new starting formula on weight gain of infants up to 6 and 12 months. The novel formula was compared with a standard formula and breastfeeding, the latter being used as the reference method. Methods 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 Innova®1 or INN), with a lower amount of protein, and enriched in α-lactalbumin protein, and with double amount of docosahexaenoic acid (DHA)/ arachidonic acid (ARA) than the standard formula; it also contained a thermally inactivated postbiotic ( Bifidobacterium animalis subsp. lactis , BPL1™ HT). Group 2 received the standard formula or formula 2 (Nutriben® or STD) and the third group was exclusively breastfed for exploratory analysis. 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. Discussion The findings of this study will provide evidence regarding the beneficial health effects of having a novel starting infant formula with reduced levels of protein, enriched in α-lactalbumin, and increased levels of DHA and ARA, and containing a postbiotic, compared with infants fed standard formula. Trial registration The trial was registered with Clinicaltrial.gov ( NCT05303077 ) on March 31, 2022, and lastly updated on April 7, 2022.