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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

Ángel Gil

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.

Objectives: The main objective of this study was to evaluate the weight gain in children fed with a new starting infant formula INN for 12 months, with a low level of total protein, enriched in α-lactalbumin protein to get a proportion of whey proteins to caseins of 70/30, as well as enriched levels of Docosahexaenoic Acid (DHA) and Arachidonic Acid (ARA) (about 2 times than STD infant formula), and supplemented with the postbiotic Bifidobacterium animalis subspecies lactis (BPL1^™ HT).

The secondary objective is to determine other measures of body composition (anthropometric data), the incidence of infections, digestive tolerance (flatulence, vomiting, and regurgitation), 3-day dietary daily intake, stool (consistency and frequency), behavior (restlessness, colic, night awakenings), the relative abundance of fecal bacterial species (fecal microbiota) and bacterial pathways (fecal metagenome), safety and tolerability of the infant formula at 2, 4, 6 and 12 months of life.

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 (Nutriben 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 subspecies 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.