The Association of Formula Protein Content and Growth in Early Infancy: A Systematic Review and Meta-Analysis

Ren, Qiqi; Li, Kaifeng; Sun, Han; Zheng, Chengdong; Zhou, Yalin; Lyu, Ying; Ye, Wanyun; Shi, Hanxu; Zhang, Wei; Xu, Yuping; Jiang, Shilong

doi:10.3390/nu14112255

Cited by 10 publications

(13 citation statements)

References 53 publications

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“…Similar results have been reported in other earlier studies [ 50 ] even with a relatively low content of protein [ 51 ]. However, previous studies on formulas with a reduced protein-to-energy ratio of up to 1.8 g/100 kcal have shown more modest differences in growth patterns compared with breastfed infants, similar to our findings [ 48 , 52 , 53 ], which supports the hypothesis that the protein-to-energy ratio plays a key role for weight gain. In our study the intake of INN formula was slightly higher than the STD formula, thus compensating for the lower energy content and protein of the former.…”

Section: Discussionsupporting

confidence: 92%

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

Plaza‐Díaz

Ruiz‐Ojeda

Morales³

et al. 2022

Nutrients

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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.

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Section: Discussionsupporting

confidence: 92%

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

Plaza‐Díaz

Ruiz‐Ojeda

Morales³

et al. 2022

Nutrients

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show abstract

“…Similar results have been reported in other earlier studies (Baird et al, 2008) even with a relatively low content of protein (Timby et al, 2014). However, previous studies on formulas with a reduced protein-energy ratio of up to 1.8 g/100 kcal have shown more modest differences in growth patterns compared with infants breastfed, similar ot our findings (Räihä et al, 2002;Koletzko et al, 2009;Ren et al, 2022), which supports the hypothesis that the protein-energy ratio plays a key role for weight gain. In our study the intake of INN formula was slightly higher than the STD formula, thus compensating for the lower energy content and protein of the former.…”

Section: -Discussionsupporting

confidence: 93%

Effects of a novel infant formula on weight gain and body composition of infants: The INNOVA 2020 study

Plaza‐Díaz

Ruiz‐Ojeda

Morales³

et al. 2022

Preprint

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Background: Breastmilk is the most appropriate food for infants and exclusive breastfeeding is highly recommended for the first six months of life to promote adequate growth and development and lower infant morbidity and mortality. Among the best-documented benefits of breastfeeding is the reduced risk of disease and infections such as pneumonia, diarrhea and acute otitis media. Nonetheless, there are situations in which the infant cannot be breastfed; therefore, it is essential to use an appropriately designed infant formula. As current infant formulas incorporate novel ingredients to partly mimic the composition of human milk, the safety and suitability of each specific infant formula should be tested by clinical evaluation in the target population. 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 (INNOVA 2020 study), as well as safety and tolerability. The complete protocol of this study has been previously issued. Study design: 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 Innova1 or INN), with a lower amount of protein, and enriched in alpha-lactalbumin protein, and with a double amount of docosahexaenoic acid (DHA)/ arachidonic acid (ARA) 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 or STD) and the third group was exclusively breastfed for exploratory analysis and used as a reference (BFD group). 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. During the first 6 months of the study, and until obtaining the main variable, the infants were only supplied with the starting formula or natural breastfeeding. Results: The primary outcome, 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 neither at 6 nor at 12 months. Likewise, BMI 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, most adverse events were reported by the STD formula group (291), followed by the INN formula (282) and the BFD groups (227). Nonetheless, most of the adverse events (95.5%) were not considered to be related to the type of feeding 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 BFD formula or INN formula. To evaluate whether there are significant differences between formula treatments, beyond growth parameters, it would seem necessary to examine more precise health biomarkers including those based on omics sciences, such as metabolomics, proteomics and metagenomics.

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“…Las características y los resultados de cada estudio incluido se resumen en la Tabla 1. Donde varios autores (Appleton et al, 2018;Giugliani, 2019;Kouwenhoven et al, 2022;North et al, 2021;Quigley et al, 2019;Rana et al, 2020;Ren et al, 2022;Santiago et al, 2019;Tang, 2018) concuerdan en que el crecimiento de los lactantes alimentados exclusivamente con leche materna es diferente al de los lactantes alimentados predominantemente con fórmula. Además, tanto Ottolini et al (2020), como Zheng et al, (2019) documentan las diferencias que existen en el desarrollo psicomotor en niños alimentados con fórmulas frente a los que se alimentan mediante la lactancia materna.…”

Section: Resultsunclassified

“…La investigación realizada por Ren et al, (2022) contribuye a asegurar que una mayor ingesta de proteínas provoca una ganancia de peso indeseada. Los resultados que obtuvo mostraron claras LATAM Revista Latinoamericana de Ciencias Sociales y Humanidades, Asunción, Paraguay.…”

Section: Discussionunclassified

“…La leche de fórmula se asocia con un mayor aumento de peso, crecimiento lineal y crecimiento de la cabeza en comparación con la leche materna de donante. Ren Q, et al (Ren et al, 2022) Revisión sistemática Metaanálisis El crecimiento del primer mes no difirió entre los bebés alimentados con fórmula y con leche materna. Los siguientes dos o tres meses de vida, los bebés que consumieron fórmulas ricas en proteínas crecieron más rápido.…”

Section: Artículo De Revisiónunclassified

See 1 more Smart Citation

Desarrollo pondoestatural y psicomotor en niños alimentados con leche materna en comparación con los alimentados con leche de fórmula

Albarracín

Zambrano

Ochoa

et al. 2023

LATAM

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La leche materna es el alimento natural para bebés pues brinda una nutrición ideal, siendo una de las formas más efectivas de asegurar la salud y la supervivencia de los niños. No obstante, la Organización Mundial de la Salud señala que, a nivel mundial, casi dos de cada tres menores de 1 año no son alimentados exclusivamente con leche materna durante los primeros seis meses de vida como se recomienda; cifra que no ha mejorado en las últimas décadas. Por lo que este estudio tiene como objetivo comparar el desarrollo pondoestatural y psicomotor en niños alimentados con leche materna frente a leche de fórmula. Los hallazgos obtenidos en esta investigación señalan que la lactancia materna parece evitar la aparición de problemas de salud indeseables como es la ganancia de peso excesiva, misma que se ha asociado con alimentación con fórmula. Debido a los resultados descritos, la lactancia materna debe ser fomentada como la mejor y más segura forma de alimentar a los bebés.

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The Association of Formula Protein Content and Growth in Early Infancy: A Systematic Review and Meta-Analysis

Cited by 10 publications

References 53 publications

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

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

Effects of a novel infant formula on weight gain and body composition of infants: The INNOVA 2020 study

Desarrollo pondoestatural y psicomotor en niños alimentados con leche materna en comparación con los alimentados con leche de fórmula

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