Search

There is a growing interest in the study of the degree of food processing and both health and nutritional outcomes. To that end, several definitions of the degree of processing have been proposed. However, when each of these is used on a common database of nutritional, clinical and anthropometric variables, the observed effect of high intakes of highly processed food, varies considerably.. Moreover, assigning a given food by nutritional experts, to its appropriate level of processing, has been shown to be variable. Thus, the subjective definitions of the degree of food processing and the coding of foods according to these classifications is prone to error is prone to error. Another issue that need resolution is the relative importance of the degree of food processing and the formulation of a processed food. Although correlational studies linking processed food and obesity abound, there is a need for more investigative studies.

Visceral leishmaniasis is responsible for up to 30,000 deaths every year. Current treatments have shortcomings that include toxicity and variable efficacy across endemic regions. Previously, we reported the discovery of GNF6702, a selective inhibitor of the kinetoplastid proteasome, which cleared parasites in murine models of leishmaniasis, Chagas disease, and human African trypanosomiasis. Here, we describe the discovery and characterization of LXE408, a structurally related kinetoplastid-selective proteasome inhibitor currently in Phase 1 human clinical trials. Furthermore, we present high-resolution cryo-EM structures of the Leishmania tarentolae proteasome in complex with LXE408, which provides a compelling explanation for the noncompetitive mode of binding of this novel class of inhibitors of the kinetoplastid proteasome.

Existing highly processed food (HPF) classification systems show large differences in the impact of these foods on biochemical risk factors for disease. If public health nutrition is to consider the degree of food processing as an important element of the link between food and health, certain gaps in research must be acknowledged. Quantifying the food additive exposure derived from HPFs is a task made challenging by the lack of data available on the occurrence and concentration of additives in food and the degree to which the natural occurrence of additives in unprocessed foods confounds exposure estimates. The proposed role of HPFs in health outcomes could also be associated with altered nutrient profiles. Differences exist within and between HPF classification systems in this regard and there are conflicting data on the impact of controlling for nutrient intake. Furthermore, research is needed on how the sensory aspects of HPFs contribute to energy intake. Current data suggest that high energy intake rate may be the mechanism linking HPFs and increased energy intake. A high priority now is to clarify the basis of definitions used to categorize foods as highly processed and, in a constructive sense, to distinguish between the contributions of nutrients, additives and sensory properties to health.

Two similarly designed studies compared user experiences with a second-generation extra-thin-wall, 5-bevel 32 G × 4 mm pen needle (PN) with redesigned hub versus four thinner commercially available PNs.Adults (18-75 years old) with type 1 or type 2 diabetes and ≥3 months of experience with pen injectors qualified for single-visit, single-blinded randomized studies. The investigational 32 G PN was compared with three 33-34 G × 3.5-4 mm PNs in Study 1 and one 34 G × 4 mm PN in Study 2. Participants completed 12 abdominal injections of 0.3 mL sterile saline using insulin pens in 6 pairs, each comprising one investigational 32 G PN and one comparator PN in random order. After each injection pair, participants compared injection pain via relative 150 mm visual analog scale (VAS) and perceived dose delivery force via relative 5 point Likert scale. Adjusted models tested injection pain scores (primary endpoint) for noninferiority and, if met, then for superiority. ClinicalTrials.gov identifiers: NCT03878758 and NCT03878745.The investigational 32 G PN met noninferiority as well as superiority criteria for less injection pain vs. each comparator (The investigational 32 G PN was associated with less participant-reported injection pain and less perceived dose delivery force compared with four thinner PNs, suggesting no additional pain reduction or force reduction benefit conferred by the thinner PNs.

Introduction Since insulin pens were first introduced in 1985, many advances have been made in pen needles (PNs). In this study we evaluated patient-reported outcomes of an investigational newly re-engineered 4 mm × 32G PN, the BD Nano™ 2nd Gen (also known by its “PRO” brand extension in many markets outside of the USA). In place of a conventional cylindrical posted hub, the investigational PN’s hub is contoured with an expanded surface area. The investigational PN also includes a redesigned inner shield that includes tactile ridges and a remodeled outer cover with improved proportions and attachment grips. Methods This was a multi-site, prospective, open-label, two-period crossover trial. Individuals with type 1 and type 2 diabetes using 32G PNs of ≤ 6 mm in length for ≥ 4 months were eligible. Subjects using 31G PNs of a similar length were eligible after a 2-week wash-in period. Subjects were assigned to one of four groups, with each group using a commercially available PN to which the investigational PN was compared. Each of the two study periods were 15 days: one with the investigational PN and the other with a comparator PN. After completing both study periods, subjects compared experiences between the two PN types. A 150-mm comparative visual analog scale (VAS) was used to evaluate overall preference (primary endpoint) and several secondary endpoints, including overall comfort, injection pain, and ease of use. Data from the four PN groups were combined after poolability was verified. Subgroup analyses were also conducted on each PN group. For VAS responses, a two-sided 95% confidence interval (CI) was calculated for average rating. Threshold for non-inferiority or superiority was established at the lower bound CI of > − 10 mm or > 0 mm, respectively. Results At baseline, average age of subjects was 55.6 years; 51.6% were female; and 85.1% has type 2 diabetes mellitus. Average diabetes duration was 14.2 years, and average duration of injecting was 7.8 years. The investigational PN demonstrated superiority for all outcomes, both primary and secondary, for all groups combined (p

Background: Insulin pump users experience periods of unexplained hyperglycemia. In some cases these may be due to insulin flow interruptions termed “silent occlusions,” which occur without activating the pump alarm and may require set replacement. Materials and Methods: In-line pressure profiles of a novel infusion set with a 6-mm, 28-gauge polymer, dual-ported catheter (BD FlowSmart™; Becton Dickinson and Co., Franklin Lakes, NJ) were compared with those of an existing infusion set (Quick-set®; Medtronic MiniMed, Northridge, CA) in two separate studies involving insulin diluent infusions over 2.5–4.5-h periods in healthy adults without diabetes. Study 1, a pilot study (n = 25), compared the occurrence of flow interruption events (silent occlusions and/or occlusion alarms) between the two infusion sets and between manual or device-assisted insertion methods. Study 2 (n = 60) was designed to show ≥50% reduction in flow interruption events with the BD set after manual insertions. (Silent occlusions were defined by a continuous pressure rise for ≥30 min.) Results: In Study 1, significantly fewer silent occlusions were seen with BD FlowSmart versus Quick-set infusion sets for both manual (three of 22 [13.6%] vs. 12 of 24 [50%]; P = 0.012) and mechanical (two of 24 [8.3%] vs. nine of 25 [36%]; P = 0.037) insertions, yielding risk reductions of 73% (95% confidence interval [CI], 25–91%) and 77% (95% CI, 17–94%), respectively. In Study 2, flow interruption events occurred in three of 117 (2.6%) and 12 of 118 (10.2%) BD FlowSmart and Quick-set infusion sets, respectively, yielding a 75% risk reduction (95% CI, 20–92%; P = 0.030). Percentage of time with flow interruption was significantly lower with BD sets in both studies (P 0.5 IU or 5 μL) occurred infrequently and did not differ between sets. Conclusions: A novel side-ported insulin infusion set demonstrated significant reductions in flow interruptions, including silent occlusions, versus a leading marketed set, which may improve insulin delivery.

Breakfast is often referred to as the most important meal of the day and in recent years has been implicated in weight control, cardio-metabolic risk factors and cognitive performance although, at present, the literature remains inconclusive as to the precise health benefits of breakfast. There are extensive reports of breakfast’s contributions to daily food and nutrient intakes, as well as many studies that have compared daily food and nutrient intakes by breakfast consumers and skippers. However, significant variation exists in the definitions of breakfast and breakfast skippers, and in methods used to relate breakfast nutrient intakes to overall diet quality. The present review describes a novel and harmonised approach to the study of the nutritional impact of breakfast through The International Breakfast research Initiative involving national dietary survey data from Canada, Denmark, France, Spain, the UK and the USA. It is anticipated that the analysis of such data along harmonised lines, will allow the project to achieve its primary goal of exploring approaches to defining optimal breakfast food and nutrient intakes. Such data will be of value to public health nutrition policy-makers and food manufacturers and will also allow consistent messaging to help consumers to optimize food choices at breakfast.

The International Breakfast Research Initiative (IBRI) set out to derive nutritional recommendations for a balanced breakfast using a standardized analysis of national nutrition surveys from Canada, Denmark, France, Spain, UK and the US. In all countries, the frequency of breakfast consumption by age was high and U-shaped with children and older adults having a higher frequency of breakfast consumption. Breakfast contributed 16% to 21% of daily energy intake. In all countries, breakfast was a carbohydrate- and nutrient-rich meal, providing more carbohydrates (including sugars), thiamin, riboflavin, folate, calcium, potassium, and magnesium, and less vitamin A, fats and sodium relative to its contribution to daily energy intakes. Breakfast consumers were stratified by tertiles of the Nutrient Rich Foods (NRF) index, used as a measure of diet quality. Breakfast intakes associated with the top tertile of NRF, along with the Codex Alimentarius international food standards and World Health Organization (WHO) diet guidelines, were used to derive the proposed nutrient recommendations. The goal was to preserve the nutrient density of existing breakfasts, while addressing concerns regarding added sugars, saturated fats, dietary fiber, and vitamin D. This initiative is unique in seeking to derive nutrient recommendations for a specific meal using the observed nutritional profile of such meal.