Growth and gut comfort of healthy term infants exclusively fed with a partially hydrolysed protein-based infant formula: a randomized controlled double-blind trial.

Objective: This study aimed to investigate growth and gut comfort of healthy infants fed with a partially hydrolysed cow's milk protein-based infant formula (pHF) compared to a standard intact cow's milk protein-based formula (IPF). Methods: A double-blind, multi-center, randomized, controlled trial was performed. Healthy full-term, exclusively formula-fed infants (n = 345), aged ≤28 days were allocated to consume either a pHF (n = 173) or an IPF (n = 172) until the age of 17 weeks. The primary outcome was equivalence of weight gain (g/d) until the age of 17 weeks. The secondary outcomes were equivalence of other growth parameters, i.e., infants' weight, length, head circumference, body mass index (BMI) and anthropometric Z-scores, while tertiary outcomes were gut comfort, formula intake, and adverse events (AEs). Results: Overall, 288 infants completed the study (pHF group: 138, IPF group: 150). No differences were observed between the two groups in weight gain (g/d) during the three-months intervention [p = 0.915 for the Per Protocol (PP) population]. The 90% CI was [-1.252 to 1.100] being within the pre-defined equivalence margin of ±3.0 g/d. Similar findings were observed in the Full Analysis Set (FAS) and the sensitivity analysis. Regarding the secondary outcomes, no differences over the intervention period were shown between the two groups in both the PP and FAS analysis sets. Average Z-scores were in the normal range based on World Health Organization (WHO) growth standards for both groups at all time points in both analysis sets. Stool consistency, amount, and colour were different in the two groups. No differences were observed in gut comfort, stool frequency, and formula intake, between the two groups. In total 14 AEs and 22 serious adverse events (SAEs) were reported of which 15 (12%) and 1 (5%) were considered as (possibly) related to the study product, respectively. Conclusions: The study demonstrates that the consumption of pHF results in adequate infant growth, equivalent to that of infants consuming IPF. Furthermore, the overall gut comfort was comparable between the two groups. Therefore, it can be concluded that the pHF is safe for and well tolerated by healthy infants. Clinical Trial Registration: https://clinicaltrials.gov/study/NCT05757323?id=NCT05757323&rank=1, identifier (NCT05757323).

The Impact of Infant Feeding Regimen on Cow's Milk Protein Allergy, Atopic Dermatitis and Growth in High-Risk Infants during the First 6 Months of Life: The Allergy Reduction Trial.

The development of early-onset cow's milk protein allergy and atopic dermatitis during the first months of life is multifactorial, including both genetic and nutritional aspects. This study aims to assess the impact of different feeding patterns on the incidence of cow's milk protein allergy, atopic dermatitis, and growth among infants with a family history of allergy. A total of 551 high-risk infants were randomly recruited from 3 European countries in three feeding regimens: exclusive breastfeeding, partially hydrolyzed formula, or standard formula with intact protein either exclusively or supplementary to breastfeeding. During the first 6 months of intervention, amongst infants with a family history of atopic dermatitis, 6.5% of partially hydrolyzed formula-fed infants and 22.7% of exclusively breastfed infants (p = 0.007) presented with atopic dermatitis respectively. Growth as assessed by weight increase did not differ between the aforementioned groups. Although cow's milk protein allergy was not related to the different milk feeding regimens in the whole cohort, when adjusting for high breast milk intake, the respective incident was significantly lower in the infants consuming partially hydrolyzed formula (p < 0.001). This data indicates that a specific partially hydrolyzed formula could serve as a more appropriate complement to breast milk compared to a standard intact protein formula in high-risk infants, to reduce the incidence of atopic dermatitis.

Prebiotic Galacto-Oligosaccharides Impact Stool Frequency and Fecal Microbiota in Self-Reported Constipated Adults: A Randomized Clinical Trial.

Constipation is a major issue for 10-20% of the global population. In a double-blind randomized placebo-controlled clinical trial, we aimed to determine a dose-response effect of galacto-oligosaccharides (GOS) on stool characteristics and fecal microbiota in 132 adults with self-reported constipation according to Rome IV criteria (including less than three bowel movements per week). Subjects (94% females, aged: 18-59 years) received either 11 g or 5.5 g of BiotisTM GOS, or a control product, once daily for three weeks. Validated questionnaires were conducted weekly to study primarily stool frequency and secondary stool consistency. At base- and endline, stool samples were taken to study fecal microbiota. A trend towards an increased stool frequency was observed after the intervention with 11 g of GOS compared to control. While during screening everybody was considered constipated, not all subjects (n = 78) had less than three bowel movements per week at baseline. In total, 11 g of GOS increased stool frequency compared to control in subjects with a low stool frequency at baseline (≤3 bowel movements per week) and in self-reported constipated adults 35 years of age or older. A clear dose-response of GOS was seen on fecal Bifidobacterium, and 11 g of GOS significantly increased Anaerostipes hadrus. In conclusion, GOS seems to be a solution to benefit adults with a low stool frequency and middle-aged adults with self-reported constipation.

Animal source foods, rich in essential amino acids, are important for linear growth and development of young children in low- and middle-income countries.

Growth faltering under 5 years of age is unacceptably high worldwide, and even more children, while not stunted, fail to reach their growth potential. The time between conception and 2 years of age is critical for development. The period from 6 to 23 months, when complementary foods are introduced, coincides with a time when growth faltering and delayed neurocognitive developments are most common. Fortunately, this is also the period when diet exercises its greatest influence. Growing up in an adverse environment, with a deficient diet, as typically seen in low- and middle-income countries (LMICs), hampers growth and development of children and prevents them from realising their full developmental and economic future potential. Sufficient nutrient availability and utilisation are paramount to a child's growth and development trajectory, especially in the period after breastfeeding. This review highlights the importance of essential amino acids (EAAs) in early life for linear growth and, likely, neurocognitive development. The paper further discusses signalling through mammalian target of rapamycin complex 1 (mTORC1) as one of the main amino acid (AA)-sensing hubs and the master regulator of both growth and neurocognitive development. Children in LMICs, despite consuming sufficient total protein, do not meet their EAA requirements due to poor diet diversity and low-quality dietary protein. AA deficiencies in early life can cause reductions in linear growth and cognition. Ensuring AA adequacy in diets, particularly through inclusion of nutrient-dense animal source foods from 6 to 23 months, is strongly encouraged in LMICs in order to compensate for less than optimal growth during complementary feeding.

A Partially Hydrolyzed Whey Infant Formula Supports Appropriate Growth: A Randomized Controlled Non-Inferiority Trial.

The aim of the current study was to investigate the effects of a partially hydrolyzed whey infant formula (PHF) on growth in healthy term infants as compared to a standard infant formula with intact protein (IPF). In a double-blind, non-inferiority, randomized controlled trial, a total of 163 healthy formula-fed infants, 55-80 days old, were recruited and randomly allocated to either the PHF (test) or the IPF (control) group. They were followed up for three months during which they were evaluated monthly on growth and development. In total, 21 infants discontinued the study, while 142 infants completed the study (test n = 72, control n = 70). The primary outcome was daily weight gain during the three months. Secondary outcomes included additional anthropometric indices at every timepoint over the intervention period. Daily weight gain during the three-month intervention period was similar in both groups with the lower bound of 95% confidence interval (CI) above the non-inferiority margin of -3 g/day [mean difference (95% CI) test vs. control: -0.474 (-2.460, 1.512) g/day]. Regarding secondary outcomes, i.e., infants' weight, length, head circumference, body mass index (BMI), and their Z-scores, no differences were observed between the two groups at any time point. The PHF resulted in similar infant growth outcomes as the standard IPF. Based on these results, it can be concluded that the partially hydrolyzed whey infant formula supports adequate growth in healthy term infants.

Effect of milk fat-based infant formulae on stool fatty acid soaps and calcium excretion in healthy term infants: two double-blind randomised cross-over trials.

BACKGROUND: Palmitic acid (PA) is predominantly esterified at the SN-2 position of triacylglycerols in human milk. PA at the SN-2 position is more efficiently absorbed and results in reduced formation of PA soaps, as well as reduced fatty acid (FA) and calcium malabsorption. Bovine milk fat (MF), a natural source of SN-2-palmitate, was used in the fat blend of infant formulae (IF) in the current study to investigate its effect on stool fatty acid soaps, calcium excretion and stool characteristics. METHODS: Two double-blind, randomised cross-over trials (CS1, CS2) were conducted in parallel with healthy term, formula-fed infants aged 9-14 weeks. After a two-week run-in period, infants in CS1 (n = 17) were randomly allocated to receive either a 50% MF-based formula (50MF) or a 100% vegetable fat (VF) formula; in CS2 (n = 18), infants received either a 20% MF-based formula (20MF) or the VF formula, in a 2 × 2-week cross-over design. At the end of each two-week intervention period, stool samples were collected for FA, FA soaps and calcium excretion analysis and stool consistency was assessed according to the Amsterdam Infant Stool Scale (AISS). RESULTS: MF-based groups showed no significant difference in PA in stools compared to VF group, although reduced stool PA soaps (CS1: 111.28 ± 18.33 vs. 220.25 ± 29.35 mg/g dry weight, p < 0.0001; CS2: 216.24 ± 25.16 vs. 233.94 ± 35.12 mg/g dry weight, p = 0.0023), total FA soaps and calcium excretion (CS1: 46.40 ± 5.27 vs. 49.88 ± 4.77 mg/g dry weight, p = 0.0041; CS2: 46.20 ± 4.26 vs. 50.47 ± 6.71 mg/g dry weight, p = 0.0067) were observed. Furthermore, the 50MF group showed a favourable lower mean stool consistency score compared to the VF group (1.64 ± 0.49 vs. 2.03 ± 0.19, p = 0.0008). CONCLUSIONS: While the use of bovine MF in IF did not affect PA concentrations in stool, lower excretion of palmitate soaps, total FA soaps and calcium was seen in healthy term infants. 50MF formula also showed improved stool consistency. The use of MF in IF could be an interesting approach to improve gut comfort and stool characteristics in infants, warranting further research. TRIAL REGISTRATION: Netherlands Trial Registry Identifier: NTR6702. Date registered: December 01, 2017.

Randomized Controlled Trial of Exercise and Nutrition Supplementation on Physical and Cognitive Function in Older Chinese Adults Aged 50 Years and Older.

OBJECTIVES: To assess whether a 24-week multidomain lifestyle intervention including a nutritional milk supplement and an exercise program had any effect on physical and cognitive function, self-rated health, and health-related quality of life in older Chinese adults. DESIGN: Randomized controlled trial. SETTING AND PARTICIPANTS: Community-living people aged 50 years and older. METHODS: 180 participants (mean age 61 ± 6 years) were randomized to 24 weeks of exercise plus nutrition supplementation or no intervention. The primary outcome was gait speed, with additional physical and cognitive function measures, self-rated health, and health-related quality of life as secondary outcomes. Information collected also included dietary intake by 3-day dietary records, and blood sampling for renal function, glycated hemoglobin, serum vitamin B12, 25-hydroxyvitamin D, and biochemical indices of bone turnover. RESULTS: There was no significant group difference in the change of gait speed, muscle strength, muscle power, cardiovascular fitness, or cognitive function over time, either by intention-to-treat or per-protocol analysis. A significant time × group effect (P = .039) on self-rated health was detected, but there was no significant time or time × group difference in the change of physical and mental health-related quality of life measures over time. In addition, moderate physical activity level was greatly increased from baseline to 24 weeks in the intervention group compared with the control group. CONCLUSIONS AND IMPLICATIONS: A 24-week exercise and nutrition supplementation program among community-living people in late midlife to early old age improved self-rated health and the overall level of physical activity, without objective improvements in physical and cognitive function.

Addressing nutritional requirements of ageing consumers in Asia-recommendations from an expert workshop.

The number of older persons in Asia is expected to triple by 2050. Ageing is associated with non-communicable chronic diseases, malnutrition, and geriatric syndromes, which influences the burden on the cost related to healthcare, health outcomes, and the quality of life. Experts in the field of older adult nutrition from Asia, Australia, and Europe were invited to participate in a two-day workshop to review the available data, current policies and programs for the ageing population in different countries of Asia to identify the gaps in knowledge and to develop recommendations for action. In Asia, most of the data pertaining to health status, nutritional status, and nutrient intake of the older persons were mainly obtained by conducting studies in nursing homes or hospitals and small cohort studies. There were limited country-specific data on this population. Moreover, the available data pertaining to different countries were difficult to compare due to differences in the reporting format and reference values used. Although nutrition initiatives and policies were realized and public education was conducted to support the older persons, most of these efforts targeted the general population rather than the older persons population segment. In healthcare management, a higher amount of education is required pertaining to the knowledge of nutritional requirements and appropriate feeding of the older persons to reduce underfeeding and its consequences. The expert group recommended the use of a systematic approach for reviewing data pertaining to different countries, initiatives, and programs to further evaluate the available data to underpin future research.

Increased Intake of Foods with High Nutrient Density Can Help to Break the Intergenerational Cycle of Malnutrition and Obesity.

A workshop held at the University Medical Center in Groningen, The Netherlands, aimed at discussing the nutritional situation of the population in general and the role diet plays during critical windows in the life course, during which the body is programmed for the development of non-communicable diseases (NCDs). NCDs are increasingly prevalent as our society ages, and nutrition is well known to play an important role in determining the risk and the time of onset of many common NCDs. Even in affluent countries, people have difficulties to achieve adequate intakes for a range of nutrients: Economic constraints as well as modern lifestyles lead people to consume diets with a positive energy balance, but low in micronutrients, resulting in increasing prevalence of obesity and suboptimal nutritional status. Information about nutrient density, which refers to the content of micronutrients relative to energy in food or diets, can help identify foods that have a low calorie to nutrient ratio. It thus allows the consumption of diets that cover nutritional needs without increasing the risk of becoming obese. Given the impact a nutrient dense, low energy diet can have on health, researchers, food industry and governments jointly should develop options for affordable, appealing nutrient-rich food products, which, in combination with physical activity, allow for optimal health throughout the life-course.

Food group and micronutrient intake adequacy among children, adults and elderly women in Greece.

The aim of the present study was to record the percentage of children, adults and elderly women in Greece meeting food and micronutrient intake recommendations. Additionally, the present study was aiming to identify the main food contributors of micronutrient intakes and assess the degree up to which meeting food intake recommendations also ensures micronutrient intake adequacy. Dietary intake data from three studies conducted in Greece (on 9-13-year-old children; 40-60-year-old adults; and 50-75-year-old women) were used to estimate mean intakes, the percentages of subjects meeting food and nutrient intake recommendations and the contribution of six core food groups to nutrient intake adequacy. The present study showed that more than 50% of children, adults and elderly women were failing to consume the recommended portions of vegetables, dairy and grains. Furthermore, children and adults consuming the recommended portions of individual core food groups had significantly lower percentages of inadequate micronutrient intakes compared to their counterparts not meeting food intake recommendations (p < 0.05). Nevertheless, even among those consuming the recommended portions from a specific core food group, the recommended intake of the corresponding micronutrient (for which this food group is the main contributor) was not always met. Indicatively, 18.2%-44.1% and 4.2%-7.0% of the populations under study were not meeting calcium and vitamin C intake recommendations, although they were consuming the recommended portions of dairy and fruits, respectively. In conclusion, these findings highlight the importance for public health policy makers to take all necessary initiatives to support the population in achieving the recommended intakes from all core food groups, but also emphasize on food variety to ensure adequate intake for all micronutrients.

Micronutrient intakes among children and adults in Greece: the role of age, sex and socio-economic status.

The aim of the present study was to report the usual nutrient intakes of sixteen micronutrients by schoolchildren, adults and the elderly in Greece and to further explore the role of age, sex and socio-economic status (SES) on meeting the recommended nutrient intakes. Dietary intake, demographic and SES data from three existing studies conducted in Greece (in 9-13-year-old children; 40-60-year-old adults; and 50-75-year-old women) were collected. The prevalence of study participants with inadequate micronutrient intakes were assessed using the estimated average requirement (EAR) cut-point method. Regarding sex and age differences, the highest prevalences of inadequate nutrient intakes occurred in post-menopausal women. In both sexes and all age groups, the prevalence of vitamin D intake below EAR reached 100%. Furthermore, nutrient intakes of 75% or more below EAR were found for vitamin E in all age groups, folate in women and for calcium and magnesium in post-menopausal women (p < 0.05). Regarding SES differences, the prevalences of inadequate calcium and vitamin C intakes were higher for children and postmenopausal women of lower SES compared to their higher SES counterparts (p < 0.05). The current study reported the highest prevalences of inadequate intakes for both sexes and all age and SES groups for calcium, folate and vitamins D and E. These findings could provide guidance to public health policy makers in terms of updating current dietary guidelines and fortifying foods to meet the needs of all population subgroups.

Platelet adhesion and activation on a shielded plasma gradient prepared on polyethylene.

Contact of blood with foreign materials evokes thrombogenic effects to an extent determined partly by the wettability of the biomaterials surface. Tools to study blood response towards a variation in materials wettability with minimal variation in chemistry are "gradient surfaces". However, most gradients have been prepared by diffusion or density immersion techniques, which results in a limited gradient range. Through glow discharge with partial shielding, gradients on polymers were prepared over a length of 5 cm, which facilitated studies to platelet adhesion on separate gradient sections. On polyethylene, advancing water contact angles varied from 90 degrees to 40 degrees, with a hysteresis of 30 degrees. ESCA indicated an increasing incorporation of oxygen towards the hydrophilic end. To examine the role of materials wettability on the activation of adhering platelets, sections of shielded plasma gradients were incubated in anticoagulated whole human blood. Fewer platelets adhered to the hydrophobic end, but those platelets were more activated than those on the hydrophilic end, as judged from their morphology and exposure of GpIIb-IIIa complex. However, partly related to the increased binding of platelets, the clotting activation after platelet deposition was highest on the hydrophilic end. Concluding, this new technique results in a large gradient range, which facilitates studies of formed blood elements in relation to the wettability. Platelets are more activated on hydrophobic polyethylene, while on moderate hydrophilic polyethylene more platelet adhesion and activation of the clotting system occurs.

The electrophoretic softness of the surface of Staphylococcus epidermidis cells grown in a liquid medium and on a solid agar.

Many Staphylococcus epidermidis strains possess capsule or slime layers and consequently the staphylococcal cell surface should be regarded as a soft, polyelectrolyte layer allowing electrophoretic fluid flow through a layer of fixed charges. The presence of such a soft layer decreases the energy barrier due to electrostatic repulsion in the interaction of the organisms with negatively charged substrata [Morisaki, H., Nagai, S., Ohshima, H., Ikemoto, E. & Kogure, K. (1999), MICROBIOLOGY: 145, 2797-2802] and hence plays an important role in their adhesion. In this paper, the authors compare the electrophoretic softness and amount of fixed charge in the outer cell surface layers of 20 S. epidermidis strains, grown in a liquid medium or on a solid agar, as determined from the dependencies of their electrophoretic mobilities upon the ionic strength of a suspending fluid. Most of the staphylococcal cell surfaces were relatively soft, with a mean cell surface softness (1/lambda) for strains grown in liquid medium of 1.7+/-0.6 nm (standard deviation over all 20 strains) which is soft by comparison with a completely bald, peptidoglycan-rich streptococcal cell surface (1/lambda=0.7 nm). When the staphylococcal strains were grown on solid agar, the cell surface softness of 17 of the 20 strains increased, sometimes by a factor of two. On average for 20 strains, the cell surface softness increased significantly (P:<0.05, Student's t-test) to 2.8+/-1.8 nm. The amount of fixed charge in the outer cell surface layer was -28+/-9 mM for bacteria grown in liquid medium and -24+/-12 mM for bacteria grown on agar. A soft, highly negatively charged polyelectrolyte layer was inferred by microelectrophoresis for all the staphylococcal cell surfaces, regardless of whether staining had indicated the presence of a capsule or slime layer.