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
Year: 2022
Type: preprint
Study design: Study Protocol
Abstract: 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.
Source: medRxiv
Authors: Francisco Javier Ruiz-Ojeda, Julio Plaza-Díaz, Javier Morales, Ana Isabel Cristina de la Torre, Antonio García-García, Carlos Nuñez de Prado, Cristóbal Coronel, Cyntia Crespo, Eduardo Ortega, Esther Martín-Pérez, Fernando Ferreira, Gema García-Ron, Ignacio Galicia, María Teresa Santos-García Cuéllar, Marcos Maroto, Paola Ruiz, Raquel Martín, Susana Viver-Gómez, Ángel Gil
Institutions: Universidad de Granada, Helmholtz Munich, Instituto de Investigación Biosanitaria de Granada, Complejo Hospitalario Universitario de Granada, Children's Hospital of Eastern Ontario, Universidad Autónoma de Madrid, Hospital Universitario de Fuenlabrada, Hospital Universitario de Móstoles, Instituto de Salud Carlos III, Spanish Biomedical Research Centre in Physiopathology of Obesity and Nutrition
Language: English
Topic: Infant Nutrition and Health
Subfield: Nutrition and Dietetics
Field: Nursing
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W4297748664