4. Discussion
’ feeding behavior, constipation
GI DISORDERS, RECRUITMENT, ADVERSE EFFECT
This double-blind RCT is, to our knowledge, the only one to compare feeding behaviors and preferences of infants fed either with GMF or conventional CMF. We observed similar levels of food enjoyment, i.e., subjective degree of pleasure experienced during feeding, for both types of formula. However, infants fed GMF, unlike those fed CMF, showed improved food responsiveness, general appetite, and quality of life.These findings are somewhat similar to those for animals and human adults. Klockars et al. [Infant formulas, e.g., CMF or GMF, must adhere to strict regulations governing their protein, carbohydrate, lipid, mineral, and vitamin content [Beyond their general composition, dairy-based infant formulas vary by source of milk ingredients (bovine or caprine and whole milk or skim milk or whey protein concentrate) and types of lipids added (vegetable oils alone or mixed with milk fat) [Our study did not detect any difference in tolerance or GI discomfort between the two formulas tested. However, the presence or absence of GI disorders was not a criterion for inclusion, i.e., there was no record at baseline. At the end of the 28 days feeding period, 27.6% of children in the ITT population (for whom data were available) exhibited constipation, with greater prevalence in the GMF group. Nevertheless, most published studies have reported that bowel movement frequency in infants given GMF is similar to or higher than with a CMF diet [Our study had limitations. For instance, we lacked the information to precisely calculate the number of subjects required for our study. Thus, we initially planned to include 100 infants. However, we fell short of this number, primarily due to the COVID-19 pandemic, which slowed recruitment and caused difficulty in obtaining parental consent for their child’s participation. On the other hand, those successfully included children were seldom lost to follow-up. Finally, while the infants’ feeding behavior was assessed using a validated scale adapted to their age group, their quality of life was measured with a modified version of the QUALIN instrument, omitting items not suitable for infants <3 months old. Unlike the original version, this modified version has not been validated. In addition, the CMF used in this study was made with whole milk instead of the more traditionally used skim milk and therefore contained some milk fat, which may have different sensory characteristics to a conventional CMF with vegetable oils only as the source of lipids.Our study also had strengths despite the intricacy of this kind of trial particularly, as parents could be perturbed by not knowing what formula their child was receiving. This situation could limit inclusions. However, we were able to include an acceptable number of patients and the compliance was good. Also, the BEBQ proved to be a useful tool for healthcare professionals to easily determine infant feeding behavior when switching to a new formula. Finally, our study provides valuable estimates for planning further trials assessing food enjoyment in infants.Although there were no differences in the enjoyment of the different formulas, infants fed with whole milk-based GMF experienced better food responsiveness and quality of life than those fed with whey-based CMF. Also, besides constipation that was more common in GMF-fed infants by parental report, no adverse effect was observed with higher frequency in the GMF group. However, studies with a larger number of subjects and with a longer follow-up duration are needed to confirm these results: trials assessing food enjoyment in infants are feasible, and further similar trials could help to draw firm conclusions about the better enjoyment of whole milk-based GMF over conventional CMF.