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][1] ([NCT05303077][2]) on March 31, 2022, and lastly updated on April 7, 2022. ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial NCT05303077 ### Funding Statement The present study was funded by Alter Farmacia S. A. The funding sponsor had no role in the design of the study, the collection, analysis, or interpretation of the data, and the writing of the manuscript. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Ethics approval has been approved by "Alter Farmacia, S.A." and by the Ethics Committee of the Drug research (ECDR). This clinical trial was carried out following the recommendations of the International Conference on Harmonization Tripartite, the ethical-legal principles established in the latest revision of the Declaration of Helsinki, as well as the current regional regulations that regulate Pharmacovigilance and food safety. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors [1]: http://Clinicaltrial.gov [2]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT05303077&atom=%2Fmedrxiv%2Fearly%2F2022%2F09%2F02%2F2022.08.31.22279449.atom