Safety evaluation of fish protein hydrolysate supplementation in malnourished children.

Amizate® is a proprietary protein hydrolysate preparation derived from Atlantic salmon (Salmo salar) using endogenous hydrolytic enzymes; it contains mostly free amino acids and short peptides, as well as small amounts of micronutrients (i.e., vitamins and minerals). In this study, the safety of supplementation with fish protein hydrolysate (Amizate®) was examined in 438 malnourished children in a randomized, placebo-controlled, double-blind, and parallel study. The children were between the ages of six to eight and met the Gomez classification for mild or moderate malnutrition. They were randomized to receive one of three interventions for four months, including a chocolate drink (control), or Amizate® (3 or 6g/day) in a chocolate drink. Administration of Amizate® was well-tolerated, with no adverse events reported. Growth (i.e., body weight gain, changes in height, and body mass index) was not negatively impacted by administration of Amizate®, and routine biochemical analysis of blood and urine samples did not reveal any abnormalities that were attributable to the intervention. Findings from this study demonstrate that daily consumption of 3 or 6g of fish protein hydrolysate (Amizate®) was safe and suitable for supplementing the diets of malnourished children.

Kinetics, safety and tolerability of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate in healthy adult subjects.

Induction of mild states of hyperketonemia may improve physical and cognitive performance. In this study, we determined the kinetic parameters, safety and tolerability of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate, a ketone monoester administered in the form of a meal replacement drink to healthy human volunteers. Plasma levels of ß-hydroxybutyrate and acetoacetate were elevated following administration of a single dose of the ketone monoester, whether at 140, 357, or 714 mg/kg body weight, while the intact ester was not detected. Maximum plasma levels of ketones were attained within 1-2h, reaching 3.30 mM and 1.19 mM for ß-hydroxybutyrate and acetoacetate, respectively, at the highest dose tested. The elimination half-life ranged from 0.8-3.1h for ß-hydroxybutyrate and 8-14 h for acetoacetate. The ketone monoester was also administered at 140, 357, and 714 mg/kg body weight, three times daily, over 5 days (equivalent to 0.42, 1.07, and 2.14 g/kg/d). The ketone ester was generally well-tolerated, although some gastrointestinal effects were reported, when large volumes of milk-based drink were consumed, at the highest ketone monoester dose. Together, these results suggest ingestion of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate is a safe and simple method to elevate blood ketone levels, compared with the inconvenience of preparing and consuming a ketogenic diet.

Weighted analysis of 2'-fucosyllactose, 3-fucosyllactose, lacto-N-tetraose, 3'-sialyllactose, and 6'-sialyllactose concentrations in human milk.

Over 150 human milk oligosaccharides (HMOs) have been identified and their concentrations in human milk vary depending on Secretor and Lewis blood group status, environmental and geographical factors, lactation stage, gestational period, and maternal health. Quantitation of HMOs in human milk has been the focus of numerous studies, however, comprehensive and weighted statistical analyses of their levels in human milk are lacking. Therefore, weighted means, standard deviations, medians, interquartile ranges, and 90th percentiles for 2'-fucosyllactose (2'-FL), 3-fucosyllactose (3-FL), lacto-N-tetraose (LNT), 3'-sialyllactose (3'-SL) and 6'-sialyllactose (6'-SL) were calculated using random sampling and the levels of these HMOs in human milk reported in the literature. Probability distributions of the reported levels were also constructed. Although the levels reported in the published studies varied, the weighted means for 2'-FL, 3-FL, LNT, 3'-SL, and 6'-SL were calculated to be 2.58, 0.57, 0.94, 0.28, and 0.39 g/L, respectively, which are consistent with those that have been previously determined in other systematic analyses. Likely due to the use of weighting, the 90th percentiles were greater than the 95% confidence limits that have been previously calculated. Our study therefore provides accurate and important statistical data to help support the level of appropriate HMO supplementation in infant formula.

Safety assessment of Streptococcus salivarius DB-B5 as a probiotic candidate for oral health.

Streptococcus salivarius DB-B5 was previously isolated from the supragingival plaque of a healthy female adult and selected for development as a probiotic candidate for oral health. Probiotics are an important emerging therapeutic method for preventing, treating, and maintaining oral health. Although S. salivarius is a predominant member of the commensal oral microbiota and generally regarded as a safe species, it is recognized that each strain needs to be comprehensively assessed for safety. This study describes the in silico, in vitro, and clinical testing that were conducted to evaluate the safety of S. salivarius DB-B5. Both 16S rRNA and multi-gene phylogenetic reconstruction was used to confirm the taxonomic identity of this strain. Bioinformatic analysis of the genome demonstrated the absence of transmissible antibiotic resistance genes or virulence factors. Phenotypic testing further showed S. salivarius DB-B5 to be susceptible to clinically relevant antibiotics. S. salivarius DB-B5 displayed weak alpha-hemolysis, and does not produce biogenic amines. In a randomized, double-blind, placebo-controlled clinical study, consumption of S. salivarius DB-B5 at 10 billion CFU/day for 4 weeks by healthy adults was safe and well-tolerated (ClinicalTrials.gov registry number NCT04492631). This work has indicated that S. salivarius DB-B5 is a safe probiotic candidate.

A Narrative Review of Childhood Picky Eating and Its Relationship to Food Intakes, Nutritional Status, and Growth.

A main characteristic of children perceived as picky eaters is their tendency to avoid certain foods or food groups. The goal of this narrative review is to provide an overview of published studies that have examined whether picky eating in childhood is in fact associated with measurable differences in food and/or nutrient intakes and growth. While picky eaters appear to consume less vegetables compared to non-picky eaters, no consistent differences were observed for the intakes of other food groups or the intakes of energy, macronutrients and dietary fiber. Although, in some studies, picky eaters had lower intakes of certain vitamins and minerals, the levels consumed generally exceeded the recommended values, suggesting nutritional requirements are being met. No consistent relationship between childhood picky eating and growth status was observed, although significant differences in body weight/growth between picky and non-picky eaters were most discernible in studies where multiple defining criteria were used to identify picky eating. The research area would benefit from the adoption of a uniform definition of picky eating. More longitudinal assessments are also required to understand the long-term impact of picky eating on nutritional status and growth.