Long-term effects of a modified, low-protein infant formula on growth and body composition: Follow-up of a randomized, double-blind, equivalence trial

Kouwenhoven, Stefanie M. P.; Antl, Nadja; Finken, Martijn J J; Twisk, Jos W. R.; Beek, Eline M. van der; Abrahamse‐Berkeveld, Marieke; Heijning, Bert J. M. van de; Goudoever, Johannes B. van; Koletzko, Berthold

doi:10.1016/j.clnu.2021.04.034

Cited by 9 publications

(9 citation statements)

References 26 publications

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“…At the age of 2, significant differences were found in body composition between the children fed with low-protein infant formula and the breastfed reference group. In contrast, feeding children a standard infant formula did not result in body composition differences compared to breastfed children [11]. Contrary to these findings, the high-protein group included in the CHOP study had a significantly higher body fat percentage, fat mass index (FMI), and FFMI than the low-protein group at the age of 2 years.…”

Section: Growth In Breastfed and Formula-fed Infantscontrasting

confidence: 57%

“…The ProtEUs study showed that the use of this infant formula with a reduced protein content of 20% was safe and supports adequate growth and body composition up until the age of 6 months [10]. Up until the age of 2 years, no differences in outcomes were found between the intervention and the control group, except for a temporal lower fat-free mass index at 4 months of age [11].…”

Section: Could Lower Protein Intake Be a Mediator In The Reduction Of...mentioning

confidence: 90%

“…Accordingly, we performed a multicenter double-blinded trial, the ProtEUs study, in which the effects of a modified low-protein infant formula were assessed for both shortterm [10] and long-term [11] growth and body composition. The ProtEUs study showed that the use of this infant formula with a reduced protein content of 20% was safe and supports adequate growth and body composition up until the age of 6 months [10].…”

Section: Could Lower Protein Intake Be a Mediator In The Reduction Of...mentioning

confidence: 99%

“…At age 2, the CHOP, EPOCH, and ProtEUs studies describe different effects of protein intake on growth and body composition [10,11,22,24,27]. Whereas CHOP and EPOCH used formulas that did not differ substantially in quality, the ProtEUs study used a different approach.…”

Section: Different Study Designs In Large Studies Addressing Protein ...mentioning

confidence: 99%

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Low-Protein Infant Formula and Obesity Risk

Kouwenhoven

Muts²,

Finken³

et al. 2022

Nutrients

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Infant formulas have been designed to mimic human milk for infants who cannot be breastfed. The overall goal is to establish similar functional outcomes to assure optimal growth, development, maturation of the immune system, and programming of the metabolic system. However, after decades of improving infant formula, growth patterns and body composition development are still different in formula-fed infants compared to breastfed infants, which could contribute to an increased risk of obesity among formula-fed infants. It has been hypothesized that the lower protein concentration of breast milk compared to infant formula influences infants’ growth and body composition. Thus, several trials in formula-fed infants with different protein intake levels have been performed to test this hypothesis. In this review, we discuss the current evidence on low-protein infant formula and obesity risk, including future perspectives and implications.

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Section: Growth In Breastfed and Formula-fed Infantscontrasting

confidence: 57%

Section: Could Lower Protein Intake Be a Mediator In The Reduction Of...mentioning

confidence: 90%

Section: Could Lower Protein Intake Be a Mediator In The Reduction Of...mentioning

confidence: 99%

Section: Different Study Designs In Large Studies Addressing Protein ...mentioning

confidence: 99%

See 2 more Smart Citations

Low-Protein Infant Formula and Obesity Risk

Kouwenhoven

Muts²,

Finken³

et al. 2022

Nutrients

Self Cite

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“…Continuous research on the composition of human milk and the biological effects of its components (Christian et al, 2021) has led to the constant evolution of infant formula, especially during the last five decades, incorporating various food ingredients to meet not only the nutritional needs of infants but also to contribute to better development and functionality (Carver, 2003). Thus, based on certain studies suggesting that a high protein intake in the early stages of life may be the cause of obesity and increased risk of metabolic disease in later stages of life (Brands et al, 2014;Zheng et al, 2018), the protein composition of infant formulas has been adjusted both in quality and quantity, reducing the protein intake of infants (Weber et al, 2014; Totzauer et al, 2018;Kouwenhoven et al, 2021). Regarding the quality of protein intake, the whey/casein ratio in infant formulas is important for the first year of life.…”

Section: Introductionmentioning

confidence: 99%

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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