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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.

Intramuscular (IM) injection can increase insulin absorption, causing hypoglycemia. Available needle lengths today are 4-12.7 mm for pens and 6-12.7 mm for syringes. We describe the distance (D) from skin surface to muscle fascia at injection sites for subcutaneous (SC) insulin therapy and recommend needle lengths to reduce IM injection risk.At two locations in the United States, skin and SC fat thicknesses were measured by ultrasound at the abdomen, arm, thigh, and buttock in diverse adults (body mass index [BMI] range, approximately 19-65 kg/m²) with diabetes (n=341 with one or more paired skin and SC measurement, permitting calculation of D). The natural log of D by body site, BMI, and gender were analyzed using a mixed model to estimate IM risk.D varied significantly by body site, BMI, and gender (each P0.001), increasing with higher BMI and in women. Median D ranged from 10.9 mm (95% confidence interval, 10.3, 11.6) at the thigh to 16.9 mm (15.9, 18.1) at the buttock. Minimum D was3 mm at the thigh and5 mm elsewhere. When inserted 90° without pinch-up, the most commonly used needle worldwide (8 mm) has estimated IM risks of 25% and 9.7%, respectively, in the thigh and abdomen, versus 1.6% and 0.1%, respectively, with a 4 mm needle. A 45° insertion reduces, but does not eliminate, IM risk with longer needles.Gender, BMI, and body site affect D; when combined with needle length and insertion angle, these factors permit detailed estimates of IM insulin injection risk. Such risk varies across sites, appears greatest at the thigh, is unnecessarily increased with 8 mm and 12.7 mm needles, and is greatly reduced with shorter-length needles and good injection technique.

The shortest pen needle (PN) for subcutaneous insulin therapy is 4 mm. Clinicians may hesitate to use it in obese patients. We report a post hoc analysis of a previously published study of the 4 mm × 32 G PN, evaluating responses in obese (≥30 kg/m(2)) and non-obese (30 kg/m(2)).Subjects (BMI 20 to 49 kg/m(2), 52% obese) with diabetes used 4 mm × 32 G PNs and either 5 mm or 8 mm PNs (both 31 G) in two, 3-week treatment periods in a randomized noninferiority cross-over trial. Percentage absolute change in fructosamine (%│Δ Fru│) was the primary endpoint. Equivalent glycemic control was defined as %│Δ Fru│ within 20% (including 95% CI). The impact of obesity on change in fructosamine, pain and reported insulin leakage from the skin is described.Clinicaltrials.gov - identifier: NCT00928057.This report is a post hoc analysis of two BMI subgroups resulting in smaller sample sizes.Of 168 who completed the study, 163 were included in the fructosamine analyses - 83 and 80 in the 4/5 mm and 4/8 mm groups, respectively. For the 4/5 mm group, mean BMI ± SD in non-obese and obese groups were 25.9 ± 2.3 and 35.0 ± 4.9 kg/m(2), respectively; 4/8 mm group 25.2 ± 2.6 and 35.6 ± 4.2 kg/m(2). BMI group was not significant for %│Δ Fru│ for either 4/5 mm or 4/8 mm. Between BMI groups, the difference of the means in %│Δ Fru│ was 0.4% (4/5 mm) and 0.3% (4/8 mm). The 4 mm PN was significantly less painful in all subject groups, except non-obese in 4/5 mm. Regardless of needle size, obese subjects reported more leakage events. For both BMI groups, there were fewer total reported leakage events when using the 4 mm vs 5 mm and 8 mm needles.The 4 mm pen needle provided equivalent glycemic control in both obese and non-obese patients compared to 5 mm and 8 mm needles with no increase in reports of skin leakage, in this post-hoc analysis. These findings should be confirmed in a prospective randomized controlled trial.

To support the implementation of a nursing research initiative in a large medical center, we collected baseline data on nurses' attitudes toward nursing research, perception of the institution as a research environment, and personal involvement in research activities. This study replicates that conducted by Rizzuto, Bostrom, Suter, and Chenitz [Predictors of nurses' involvement in research activities. Western Journal of Nursing Research , 16 (2), 193–204] in 1994. To better understand the findings, we traced the historical evolution of nursing research through successive American Nurses Association codes of ethics. Our review of the literature presents (in table format) factors that encourage and those that impede nursing research. The study results validate the work of other researchers: nurses' positive attitudes toward research are discordant with their actual involvement in research activities. The data suggest that positive attitudes and perceived institutional support are not enough to increase involvement in nursing research; as such, we describe additional institutional infrastructure and forms of educational support.

To determine whether insulin delivered via a 4-mm × 32-gauge pen needle (PN) provides equivalent glycemic control as 8-mm × 31-gauge and 12.7-mm × 29-gauge PNs in obese (body mass index ≥30) patients with diabetes.This prospective, multicenter, randomized, open-label, 2-period, crossover, equivalence, home-based study was conducted from October 26, 2010, through May 31, 2012. After a 3-week wash-in period, eligible patients aged 18 to 80 years with a hemoglobin A1c (HbA1c) level of 5.5% to 9.5% (37-80 mmol/mol) were randomized to compare either 4- vs 8-mm PNs or 4- vs 12.7-mm PNs, using each of the 2 assigned PNs for 12 weeks in random order. The primary outcome was change in HbA1c level, with equivalence limits of ±0.4%.The 274 patients randomized (mean ± SD age, 56.7±11.0 years) had a mean ± SD body mass index of 37.0±6.1 (range, 29.1-59.9) and took up to 350 U of insulin daily; 226 patients were included in the modified intention-to-treat analysis. Mean (95% CI) changes in HbA1c levels with the 4-mm PN were -0.08% (-0.21 to 0.06) and -0.10% (-0.19 to 0.00) vs the 8- and 12.7-mm PNs, respectively, within equivalence margins. The 4-mm PN was less painful than the larger PNs (P.05), with similar leakage rates reported (4.1%-4.3%). Patients preferred the 4-mm PN over the 12.7-mm PN (P.05) but not significantly vs the 8-mm PN. There were no differences between PNs in insulin doses and hypoglycemic or hyperglycemic adverse event rates.The 4-mm × 32-gauge PN provides equivalent glycemic control as 8- and 12.7-mm PNs in obese patients with diabetes, with less pain and no increase in leakage. Shorter PNs should be considered in all insulin-requiring patients with diabetes, including those who are obese.clinicaltrials.gov Identifier: NCT01231984.

Diabetes is a chronic condition with high morbidity, mortality, and prevalence rates that results in high human and financial costs. Coordinating diabetes care with a disease management approach th...

BackgroundPen needles (PNs) are essential for insulin injections using pen devices. PN characteristics affect patients’ injection experience.ObjectiveThe goal of this study was to evaluate the impact of a new extra-thin wall (XTW) PN versus usual PNs on overall patient preference, ease of injection, perceived time to complete the full dose, thumb button force to deliver the injection, and dose delivery confidence in individuals with diabetes mellitus (DM). Subjects injected insulin with the KwikPenTM (Eli Lilly and Company, Indianapolis, Indiana), SoloSTAR® (sanofi-aventis U.S. LLC, Bridgewater, New Jersey), and FlexPen® (Novo Nordisk A/S, Bagsvaerd, Denmark) insulin pens, and included some with impaired hand dexterity.MethodsWe first performed quantitative testing of XTW and comparable PNs with the 3 insulin pens for thumb force, flow rate, and time to deliver medication. A prospective, randomized, 2-period, open-label, crossover trial was then conducted in patients aged 35 to 80 years with type 1 or type 2 DM who injected insulin by pen for ≥2 months, with at least 1 daily dose ≥10 U. Patients who used 4- to 8-mm length PNs with 31- to 32-G diameter were randomly assigned to use their current PN or the same/similar size XTW PN at home for ~1 week and the other PN the second week. They completed several comparative 150-mm visual analog scales and direct questions at the end of period 2.ResultsXTW PNs had statistically significant better performance for each studied PN characteristic (thumb force, flow, and time to deliver medication) for all pens combined and each individual pen brand (all, P ≤ 0.05). Of 216 patients randomized to study groups (80, SoloSTAR; 77, FlexPen; 59, KwikPen), 209 completed both periods; 198 were evaluable. Baseline characteristics revealed a mean (SD) age of 60.8 (9.3) years, insulin pen use duration of 4.3 (4.1) years, and mean total daily dose of 75.1 (52.3) U (range, 10–420 U). Approximately 50% of patients were female; 81.5% were white and 14.8% were black; and 89.8% had type 2 DM. Nearly 99% used a single PN: 8 mm, 49.5%; 5 mm, 24.1%; 6 mm, 14.4%; and 4 mm, 12.0%. Patients rated the XTW PNs (mean [95% CI]) as preferable by a mean of 31.9 mm (27.2–36.6), P < 0.001; XTW PNs required less thumb force, less time to inject the dose, and were rated as providing greater confidence in full dose delivery by 28.4 mm (23.7–33.2), 21.7 mm (17.0–26.4), and 24.4 mm (19.7–29.1), respectively; all, P < 0.001. Results were similar for each of the 3 pens, those with impaired hand dexterity, and for all users of 4-mm PNs. Skin leakage and insulin dripping from the needle tip were rated as less frequent with the XTW PNs (P < 0.05). The most common adverse events were hypoglycemia in 8.3% and 6.0% of patients using XTW PNs and current PNs (P = NS), respectively; hyperglycemia occurred in 2.9% and 4.1% (P = NS). None of the adverse events was serious or considered device related.ConclusionsXTW PNs were preferred overall, rated as requiring less time and less thumb force to inject, and providing greater confidence in completing a full dose compared with usual PNs in this group of patients with type 1 or type 2 DM. ClinicalTrials.gov identifier: NCT01852136

Background: Multiple factors impact subcutaneous insulin injection pain. Injection devices [e.g., syringe or pen needle (PN)] affect pain due to needle length, diameter, needle polishing and lubrication, and needle tip geometry. Methods: We evaluated a modified 5-bevel PN tip in 32 G × 4 mm 31 G × 5 mm and 8 mm PNs vs the equivalent marketed 3-bevel PNs in laboratory penetration force testing, as well as in insulin-taking subjects for overall acceptability, comparative pain, and preference. The clinical tests were done in three ways: paired insertions with the subjects blinded to PN tip geometry, after brief at-home use of 5-bevel PNs, and again with subjects informed about each needle’s tip geometry in paired insertions. Results: Average penetration force in a skin substitute was 23% lower with the 5-bevel PNs vs similar 3-bevel PNs (p ≤ 0.01). In blinded testing and after at-home use, patients rated the 5-bevel needle as acceptable. After shortterm home use, patients rated the 5-bevel PN less painful and preferable to their usual PN (both p < 0.01). In paired, informed testing, the 5-bevel PN was less painful and preferred to subjects’ currently used needles (p ≤ 0.01) and to other marketed PNs (p < 0.01). Conclusions: Needle tip geometry affects penetration force. When blinded, patients did not distinguish differences in PN tip geometry with fine-gauge PN insertions. A 5-bevel needle tip is perceived as less painful and is preferred by subjects following home use for usual injections. Similar results occurred when patients were informed that they were using a needle with a modified tip.

The Ras/RAF/MEK/ERK mitogen-activated protein kinase (MAPK) signaling pathway plays a central role in the regulation of cell growth, differentiation, and survival. Expression of mutant BRAF(V600E) results in constitutive activation of the MAPK pathway, which can lead to uncontrolled cellular growth. Herein, we describe an SAR optimization campaign around a series of quinazoline derived BRAF(V600E) inhibitors. In particular, the bioisosteric replacement of a metabolically sensitive tert-butyl group with fluorinated alkyl moieties is described. This effort led directly to the identification of a clinical candidate, compound 40 (CEP-32496). Compound 40 exhibits high potency against several BRAF(V600E)-dependent cell lines and selective cytotoxicity for tumor cell lines expressing mutant BRAF(V600E) versus those containing wild-type BRAF. Compound 40 also exhibits an excellent PK profile across multiple preclinical species. In addition, significant oral efficacy was observed in a 14-day BRAF(V600E)-dependent human Colo-205 tumor xenograft mouse model, upon dosing at 30 and 100 mg/kg BID.

Pen needles (PN) for subcutaneous insulin therapy have become smaller; 5 mm PNs are now the shortest in use. We evaluated the safety, efficacy and patient ratings of a new 4 mm x 32 gauge (G) PN.Subjects with type 1 and type 2 diabetes and HbA1c 5.5% to 9.5% participated in a randomized non-inferiority cross-over trial, at four U.S. centers. Subjects used 4 mm x 32G PNs and either 5 mm x 31G PNs (4/5 mm) or 8 mm x 31G PNs (4/8 mm) in two, 3-week treatment periods; order of needle use was controlled. Subjects were either 'low dose' or 'regular dose' users (highest single insulin doseor= 20 units and 21-40 units, respectively). Percent absolute change in serum fructosamine (% |Delta Fru|) was the primary endpoint; unexplained, severe hypo- or hyperglycemia was a secondary measure. Leakage at injection sites and pain measured by visual analog scale were tertiary measures. Equivalent glycemic control was defined á priori as % |Delta Fru| (including 95% CI) within 20%; 40 subjects per subgroup provides 90% power at alpha = 0.05.The study was registered on clinicaltrials.gov (identifier: NCT00928057).Of 173 subjects randomized, 168 completed the study, and 163 were included in the fructosamine analyses--83 and 80 in the 4/5 mm and 4/8 mm groups, respectively. Subjects were 56% male, mean 52.6 yrs, 63% type 2. Baseline HbA1c = 7.5 +/- 1.0% and fructosamine 301 +/- 55.1 micromol/L. Mean % |Delta Fru| was 4.9% (95% CI 3.8, 6.0) and 5.5% (4.5, 6.4), respectively, for the 4/5 mm and 4/8 mm groups, meeting glycemic equivalence criteria; results were similar in both dose groups. The median |Delta Fru| was 11.0 micromol/L (8.0, 13.0) and 13.5 micromol/L (9.8, 18.0) for the 4/5 mm and 4/8 mm groups, respectively. Unexplained, severe hypo- and hyperglycemic episodes were infrequent and not different between PNs. The 4 mm PN was rated significantly less painful and preferred by approximately 2/3 of subjects (p0.01). All three PNs had similar reported injection site leakage.The study was of relatively short duration, in adults in the U.S. Further trials in other patients (e.g., GLP-1 users, pediatrics, obese) should be performed.The 4 mm x 32G PN provided equivalent glycemic control compared to 31G, 5 mm and 8 mm PNs with reduced pain, no difference in insulin leakage and was preferred by patients.

During subcutaneous insulin therapy, inadvertent intramuscular (IM) injections may increase pain and/or adversely affect glucose control. The most appropriate needle length for patients depends on skin thickness (ST) and the distance to muscle fascia. ST and subcutaneous adipose layer thickness (SCT) were measured in adults with diabetes.A total of 388 US adults with diabetes (in three BMI subgroups:25, 25-29.9, andor=30 kg/m(2)) with diverse demographic features were evaluated. Each subject had ultrasound measurements of ST and SCT at four injection sites.Subjects had BMI 19.4-64.5 kg/m(2), age 18-85 years; 40% Caucasian, 25% Asian, 16% Black, 14% Hispanic; 28% type 1 diabetes. Mean ST (+/-95% CI) was: arm 2.2 mm (2.2, 2.3), thigh 1.9 mm (1.8, 1.9), abdomen 2.2 mm (2.1, 2.2) and buttocks 2.4 mm (2.4, 2.5). Multivariate analyses showed body site, gender, BMI, and race are statistically significant factors for ST but effects were small. Thigh ST was0.6 mm thinner than the buttocks. Differences of 10 kg/m(2) account for 0.2 mm ST variation. Mean SCT was: arm 10.8 mm (10.2, 11.3), thigh 10.4 mm (9.8, 10.9), abdomen 13.9 mm (13.2, 17.7) and buttocks 15.4 mm (14.7, 16.2). Females had 5.1 mm greater SCT. Differences of 10 kg/m(2) account for 4 mm SCT variation.A few mild hypo- or hyperglycemia events, unrelated to study procedure, were detected and treated before subject discharge from study visits.Only adults in the US were studied; some measurements could not be obtained on every subject, at every injection site.Injection site ST does not differ by clinically significant degrees in demographically diverse adults with diabetes; SCT has a wider range. Needlesor=8 mm, inserted perpendicularly, may frequently enter muscle in limbs of males and those with BMI25 kg/m(2). With 90 degrees insertion, needles 4-5 mm enter the subcutaneous tissue with minimal risk of IM injection in virtually all adults. These data will assist recommending appropriate length needles for subcutaneous insulin injections in adults.

The nutrient targets derived from analysis of the relation between nutrient intake and disease prevalence or other scientific evidence, have to be translated into food-based guidelines in order to be understood by die general population. Furthermore, Food-Based Dietary Guidelines (FBGD) have to be realistic, attainable and culturally acceptable and should also give consideration to relevant social, economic, agricultural and environmental factors affecting food availability and eating patterns. This requires a diorough understanding of the relation between foods, food patterns and nutrient intakes in the population. The aims of Working Party 2 were to propose a framework for strategies in the development of FBDG and to examine existing data for nutrient and food intakes in the EU.MethodsThe over-all strategy given by the joint FAO/WHO consultation 1995 was used as the starting point, i.e. target foods or food patterns for public health nutrition programmes should be identified from an analysis of prevailing food and nutrient intakes. Prevailing data for food and nutrient intakes in 14 EU countries were examined and different principles and options for the derivation of FBDG were explored. Methodological issues and their influence on the interpretation of data for the development of FBDG were also examined.ResultsThe process from nutrients to foods can be briefly: 1) identification of major food sources of the nutrient of interest, 2) identification of foods contributing substantially to population intakes, 3) identification of foods or food patterns compatible with desirable nutrient intakes or explaining variations in nutrient intakes, 4) formulation of FBDG into foods, portion sizes, frequency of intake, meal composition taking attainability and acceptability as well as compatibility of co-existing guidelines into account.The level of complexity that can be applied in the analytical approaches depends on the characteristics of available intake data. A detailed analysis requires data on an individual level for nutrients, foods, food patterns, eating and meal habits etc. When individual data are available different analytical approaches (examination of distribution of intakes, correlation analysis between foods and nutrients, examination of food intakes in compliers/non-compliers to nutrient goals, discriminant analysis, cluster/factor analysis) can be used to identify key foods or food patterns fulfilling nutrient goals.The examination of prevailing food and nutrient intake data in the EU revealed:– a number of methodological differences in approaches to dietary surveys exist in the EU countries e.g. regarding mediods used, selection of population, classification of foods, which have to be kept in mind in pan-EU comparisons at present there is a substantial gap between actual intakes and present nutrient goals suggesting that major changes of dietary habits are needed– while some food patterns were consistently related to intake of specific nutrients in most EU countries, other patterns showed large variations between countries– methodological issues, such as survey duration, survey techniques, under- or over-reporting, could have substantial influence on the identification of target foods or food patterns.ConclusionA science-based analysis of nutrient and food intakes allows development of FBDG, which, if implemented, are likely to result in mean population intakes closer to nutrient goals. Acknowledging the social and cultural differences within the EU as well as the need to focus on the most relevant public health problem in die population, FBDG should first be developed widiin member states. Harmonisation of survey methods within the EU would facilitate development of regional and EU FBDG.