Gastrointestinal Tolerance of an Infant Formula Manufactured from Extensively Hydrolysed Protein in Healthy Term Infants.

The evaluation of secondary parameters of a prospective, randomised, controlled, multicentre intervention trial aimed to analyse gastrointestinal tolerance of an infant formula manufactured from extensively hydrolysed whey protein (eHF) compared to intact cow's milk protein (control formula, CF) in healthy term infants. Infants ≤ 25 days of age, who were exclusively formula-fed, were randomised to receive eHF or CF for at least three months up to 120 days of age. An exclusively breastfed reference group (BF) was included for descriptive comparison. Infants' gastrointestinal tolerance was evaluated based on stool parameters, the Amsterdam Infant Stool Scale (AISS), the Infant Gastrointestinal Symptom Questionnaire (IGSQ), and sleeping patterns. Of 359 infants included, 297 randomised (eHF: n = 149, CF: n = 148) and 41 BF infants completed the study per protocol. All tolerance parameters were comparable between eHF and CF. Stool was predominantly soft and yellow in colour. Stool was more frequently green in eHF than CF. BF infants had more frequent stools, which were mainly watery or soft and yellow, and comparable IGSQ scores (descriptive). Irrespective of group, all gastrointestinal and sleep parameters showed signs of maturation with increasing age. In conclusion, eHF showed gastrointestinal tolerance as good as CF in healthy infants. Both formulae were well-tolerated.

Correction: Otten et al. Safety and Suitability of an Infant Formula Manufactured from Extensively Hydrolysed Protein in Healthy Term Infants. Nutrients 2023, 15, 1901.

In the original publication [...].

Safety and Suitability of an Infant Formula Manufactured from Extensively Hydrolysed Protein in Healthy Term Infants.

We aimed to demonstrate that healthy term infants experience noninferior growth with infant formula manufactured from extensively hydrolysed whey protein (eHF) compared to intact cow's milk protein (control formula, CF). This prospective, randomised, double-blind, parallel-group, controlled, multicentre trial included healthy term infants who were exclusively formula-fed. Infants ≤ 25 days of age received eHF or CF for at least three months up to 120 days of age, with a follow-up until 180 days of age. A reference group included exclusively breastfed infants (BF). Of 318 infants randomised, 297 (148 CF, 149 eHF) completed the study per protocol. Weight gain up to 120 days of age was noninferior (margin -3.0 g/day) in eHF (28.95 (95% CI: 27.21; 30.68) g/day) compared to CF (28.85 (95% CI: 27.10; 30.61) g/day) with a difference in means of 0.09 g/day and a lower limit of the one-sided 97.5% CI of -0.86 g/day (p < 0.0001 for noninferiority testing). Weight gain remained comparable during follow-up. Further anthropometric parameters did not differ between the infant formula groups throughout the study. Growth was comparable in BF. No relevant safety issues were observed. To conclude, eHF meets infant requirements for adequate growth during the first six months of life and can be considered safe and suitable.

Impact of an Infant Formula Containing a Novel Fat Blend (Cow's Milk Fat, Fish and Vegetable Oil) and Prebiotics on Stool Fatty Acid Soaps and Erythrocyte Fatty Acid Profiles in Full-Term Healthy Newborns.

INTRODUCTION: Recently, new commercial infant formulas have been composed considering novel fat blends and oligosaccharides to better resemble the fatty acid (FA) composition and stereospecific distribution (e.g., increased amount of ß-palmitate) as well as probiotics content of human breast milk. We hypothesized that these newly composed infant formulas may decrease fecal FA soap excretion and may positively affect erythrocyte FA profiles compared with regular formulas. METHODS: Healthy infants were randomly assigned to receive a high-sn-2-palmitate formula (>25% of the PA is esterified to the sn-2 position of the glycerol backbone, verum: n = 30) or a "standard" formula containing <10% of PA in sn-2 position and no oligosaccharides (control: n = 27); a non-randomized group of breast-fed infants served as control. Anthropometric data of the infants (body weight, recumbent length, and head circumference) were recorded at inclusion (visit 1) and 6 and 12 weeks after onset of intervention (visits 2 and 3). Blood samples for erythrocyte FA analysis (gas chromatography) were taken at visits 1 and 2; stool samples were collected at visit 2. RESULTS: Quantitative formula intake (mL/kg body weight × day) at visit 2 (verum: 155 ± 30, control: 164 ± 30) and visit 3 (verum: 134 ± 26, control: 134 ± 21) was comparable. Six weeks after onset of intervention, stool total FA soaps, palmitate soaps, and total FAs were similar in both formula-fed groups but significantly higher than in breast-fed infants. During the 6-week intervention, erythrocyte palmitate decreased significantly from baseline in all 3 groups with no group differences (verum: 29.20 ± 1.17 to 27.12 ± 0.66, control: 29.88 ± 2.00 to 27.01 ± 0.94, breast-fed: 30.20 ± 0.86 to 26.84 ± 0.98). For selected FAs, significant changes over time in verum and control group were obvious but without formula effects. Some variations in the FA profile of breast-fed infants compared to both verum and control groups were observed. CONCLUSIONS: In contrast to our hypothesis, feeding a newly composed infant formula based on a fat blend with 25% of PA in the sn-2 position of triacylglycerols and supplemented with a prebiotic could not decrease insoluble FA soap excretion compared with a standard product; in this respect, breastfeeding is obviously the best choice. Surprisingly, erythrocyte FA profiles were comparable in formula-fed and breast-fed infants; obvious alterations in FA composition of the respective fat sources and structure did not affect FA incorporation into membranes. Caution should be, however, exercised in drawing robust conclusions in the absence of larger, adequately powered intervention studies.

Infant formula with cow's milk fat and prebiotics affects intestinal flora, but not the incidence of infections during infancy in a double-blind randomized controlled trial.

BACKGROUND: The postnatal intestinal colonization of human milk-fed and formula-fed infants differs substantially, as does the susceptibility to infectious diseases during infancy. Specific ingredients in human milk, such as prebiotic human milk oligosaccharides and a specifically structured fat composition with high proportion of beta-palmitic acid (beta-PA) promote the growth of intestinal bifidobacteria, which are associated with favorable effects on infants' health. The present study investigates whether addition of prebiotic galactooligosaccharides (GOS) in combination with higher amounts of beta-PA from cow's milk fat in infant formula positively affects gut microbiota and the incidence of infections in formula-fed infants. METHODS: In a double-blind controlled trial, formula-fed infants were randomly assigned to either receive an experimental formula containing a higher proportion of beta-PA (20-25%) from natural cow's milk fat, and a prebiotic supplement (0.5 g GOS/100 ml), or a standard infant formula with low beta-PA (< 10%), without prebiotics. A breast-fed reference group was also enrolled. After 12 weeks, fecal samples were collected to determine the proportion of fecal bifidobacteria. The number of infections during the first year of life was recorded. RESULTS: After 12 weeks, the proportion of fecal bifidobacteria was significantly higher in infants receiving formula with high beta-PA and GOS compared to control, and was similar to the breast-fed group (medians 8.8%, 2.5%, and 5.0% respectively; p < 0.001). The incidence of gastrointestinal or other infections during the first year of life did not differ between groups. CONCLUSIONS: The combination of higher amounts of beta-PA plus GOS increased significantly the proportion of fecal bifidobacteria in formula-fed infants, but did not affect the incidence of infections. TRIAL REGISTRATION: The study protocol was registered with Clinical Trials (Protocol Registration and Results System Trial ID: NCT01603719 ) on 05/15/2012 (retrospectively registered).

Adequacy and safety of α-lactalbumin-enriched low-protein infant formula: A randomized controlled trial.

OBJECTIVES: The aim of this study was to demonstrate suitability and safety of an infant formula enriched with α-lactalbumin with a reduced protein content of 1.89 g protein/100 kcal. METHODS: This was a randomized, double-blind controlled trial with 80 healthy newborn infants who were assigned to receive either an isocaloric low- or high-protein content formula (1.89 versus 2.1 g/100 kcal). The low-protein content formula was enriched with α-lactalbumin. A breast-fed reference group of 40 infants was studied concurrently. Anthropometric measures were taken at inclusion, after 6 and 12 wk as well as after 6 and 12 mo of follow-up. Primary outcome was weight gain in g/d between study inclusion to 12 wk. Secondary outcomes included anthropometric measures expressed in Z-scores, mean formula consumption, and caloric intake as well as food tolerance. RESULTS: Fifty-two infants in the formula group (low protein: 26, high protein: 26) and 32 in the breast-fed reference group completed the 3-mo intervention period. There was no difference in weight gain among feeding groups at the end of the intervention period. Mean weight gain in g/d was 32 in the low-protein, 31 in the high-protein, and 33 in the breast-fed reference group. No significant difference was found between study groups in Z-scores for weight, length, head circumference, weight-for-length, or body mass index nor for fat percentage at end of intervention and after follow-up. CONCLUSION: α-lactalbumin-enriched formula with a protein content of 1.89 g protein/100 kcal is safe and supports adequate growth.

Mothers' Consumption of Soy Drink But Not Black Tea Increases the Flavonoid Content of Term Breast Milk: A Pilot Randomized, Controlled Intervention Study.

OBJECTIVE: We performed a pilot RCT to prove the hypothesis that a controlled ingestion of polyphenol-rich beverages (soy drink, decaffeinated black tea) in nutritive dosages by nursing women has an effect on the composition (flavonoid concentration, total antioxidant capacity) of breast milk. METHODS: Healthy nursing women were supplemented with either 250 mL of a soy drink (12 mg isoflavones; n = 18), 300 mL decaffeinated black tea (67 mg catechins; n = 18), or 300 mL water (n = 8, control) for 6 days. Milk samples were collected before, during, and after intervention. Flavonoid content (isoflavones/catechins, HPLC) and total antioxidant capacity of milk and test drinks in milk specimens were assessed. RESULTS: Isoflavone content (genistein and daidzein) in breast milk increased up to 12 nmol/L after soy drink consumption; the major flavonoids constituents of black tea (catechin, epicatechin, and respective conjugates) could not be detected in milk samples. With both interventions, the total antioxidant capacity of breast milk was not affected. CONCLUSIONS: Mothers' daily consumption of a soy drink considerably increases isoflavone content of breast milk resulting in an estimated daily exposure of 9.6 nmol isoflavones in a 4-month-old suckling infant. Luminal flavanol uptake from black tea consumed by the nursing mother may be too low to affect flavanol concentrations in breast milk.

The reactions of parents who think that a child is dying in a seizure--in their own words.

PURPOSE: The goal of this work was to report the words parents use to describe a seizure in which they thought their child was dying, so as to increase the awareness of professionals with respect to the impact seizures may have on family life. METHODS: An audit was carried out on 234 cases from a specialist epilepsy center and 35 cases from a tertiary referral outpatient clinic. RESULTS: Of the 54 parents who thought their child was dying in a seizure, in 45 cases the parents' exact words were recorded in the first person, and in 9 cases, their words were reported in the third person. Many parents took actions that illustrated their high degree of concern: 32 children were taken to hospital, 18 by ambulance, and 3 parents gave mouth-to-mouth resuscitation. CONCLUSIONS: Seizures often cause major concern in parents and many think that their child is dying. Prolonged seizures and limpness and/or cyanosis appear to be associated with this fear. Professionals can gain valuable insight into the impact of seizures on parents by asking them about their reactions to seeing their child having a seizure.

Relation between coronary calcium and 10-year risk scores in primary prevention patients.

In 380 patients, coronary calcifications were quantified by electron beam tomography and compared with the predicted 10-year cardiovascular event risk determined by the Framingham equation, Adult Treatment Panel III tables, and the PROCAM algorithm. The correlation between the amount of calcium and the predicted cardiac event risk was low (correlation coefficient range 0.19 to 0.28). The assessment of coronary calcium may thus potentially yield information that is additive to the analysis of traditional risk factors.