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The Bioequivalence of Two Peficitinib Formulations, and the Effect of Food on the Pharmacokinetics of Peficitinib: Two-Way Crossover Studies of a Single Dose of 150 mg Peficitinib in Healthy Volunteers.
Shibata, M, Toyoshima, J, Kaneko, Y, Oda, K, Kiyota, T, Kambayashi, A, Nishimura, T
Clinical pharmacology in drug development. 2021;(3):283-290
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Abstract
The marketed tablet formulation of peficitinib differs from the tablet used during the clinical trials. The bioequivalence of the marketed formulation and developmental tablet, and the food effect on the marketed formulation, were analyzed in 2 Japanese open-label, randomized, 2-way crossover studies in healthy male volunteers. Volunteers received a single oral dose of the marketed 150-mg peficitinib tablet under fasted conditions (bioequivalence), and under fed or fasted conditions (food effect). Bioequivalence was compared with the developmental 150-mg tablet. Samples for pharmacokinetic analysis were collected before dose and ≤72 hours after dose. Safety assessments included adverse events, vital signs, and laboratory variables. In total, 40 and 18 subjects were randomized to the bioequivalence and food effect studies, respectively. The 2 peficitinib formulations were bioequivalent (90% confidence intervals of the geometric mean ratios for Cmax and AUCt of peficitinib were within predefined limits of 0.8 to 1.25). The AUClast and the Cmax of the marketed tablet were 36.8% and 56.4% higher, respectively, under fed versus fasted conditions. Peficitinib was well tolerated. The marketed 150-mg tablet formulation of peficitinib was bioequivalent to the developmental 150-mg formulation, with no discernible safety differences. Bioavailability increased under fed conditions with the marketed tablet formulation.
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The Effect of Food on the Single-Dose Bioavailability and Tolerability of the Highest Marketed Strength of Duloxetine.
Rizea-Savu, S, Duna, SN, Ghita, A, Iordachescu, A, Chirila, M
Clinical pharmacology in drug development. 2020;(7):797-804
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Duloxetine is a combined serotonin and norepinephrine reuptake inhibitor indicated in adults for the treatment of major depressive disorder, diabetic peripheral neuropathic pain, and generalized anxiety disorder. The aim of these studies was to evaluate the effect of food on the pharmacokinetics and safety of duloxetine 60-mg gastroresistant hard capsules following single-dose administration. The data were obtained from 2 phase 1 bioequivalence studies, 1 in a fasting state and the other under fed conditions. Both studies have shown that, when administered as a single dose in the same prandial state, the test and reference duloxetine treatments were bioequivalent and exhibited similar safety profiles. The mean fed and fasting pharmacokinetic parameters and drug-related adverse events from the 2 studies were compared in order to assess the effect of food on the duloxetine bioavailability and respectively, tolerability. Administration of duloxetine in fed conditions increased peak plasma concentration by up to 30% and delayed mean time to peak concentration by an average of 1.15 hours while having an insignificant effect on extent of absorption (area under the plasma concentration-time curve in fed state within ±6% as compared with fasting conditions). Even though peak plasma levels were substantially higher in the fed state, there was no negative impact on the drug's safety profile. Actually, administration with food resulted in a lower average number of adverse events per single dose exposure. The negligible variation in overall systemic exposure suggests that efficacy remains unchanged irrespective of administration conditions; however, a better tolerability of the 60-mg dose is expected when the drug is taken with food.
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[Frequency of skin reactivity to food allergens in allergic patients].
Camero-Martínez, H, López-García, AI, Rivero-Yeverino, D, Caballero-López, CG, Arana-Muñoz, O, Papaqui-Tapia, S, Rojas-Méndez, IC, Vázquez-Rojas, E
Revista alergia Mexico (Tecamachalco, Puebla, Mexico : 1993). 2017;(3):291-297
Abstract
BACKGROUND Food allergy is deemed to have a worldwide prevalence ranging from 2 to 10 %. OBJECTIVE To determine the frequency of skin reactivity to food allergens by age groups. METHODS Cross-sectional, descriptive, prolective, observational study. Patients aged from 2 to 64 years with symptoms consistent with allergic disease were included. Skin prick tests were carried out with food allergens. Frequencies and percentages were estimated. RESULTS One-hundred and ninety-one patients were included, out of which 63.4% were females. Mean age was 22.5 years; 19.3 % showed positive skin reactivity to at least one food. Distribution by age group was as follows: preschool children 13.5 %, schoolchildren 24.3 %, adolescents 2.7 % and adults 59.5 %. Diagnoses included allergic rhinitis in 84.3 %, asthma in 19.4 %, urticaria in 14.1 % and atopic dermatitis in 8.4 %. Positive skin reactivity frequency distribution in descending order was: soybeans with 5.2 %, peach with 4.7 %, grapes, orange and apple with 3.6 %, nuts with 3.1 %, pineapple, avocado, tomato and tuna with 2.6 %. CONCLUSION The frequency of skin reactivity to food allergens was similar to that reported in the national and Latin American literature, but sensitization to each specific allergen varied for each age group.
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Liquid versus solid energy intake in relation to body composition among Australian children.
Zheng, M, Allman-Farinelli, M, Heitmann, BL, Toelle, B, Marks, G, Cowell, C, Rangan, A
Journal of human nutrition and dietetics : the official journal of the British Dietetic Association. 2015;:70-9
Abstract
BACKGROUND The debate about whether energy consumed in liquid form is more obesogenic than energy consumed in solid form remains equivocal. We aimed to evaluate the effects of liquid versus solid energy intake and different beverage types on changes in childhood adiposity. METHODS Our analyses included 8-year-old Australian children (n = 158) participating in the Childhood Asthma Prevention Study. Dietary information was collected using three 24-h recalls at age 9 years. Multivariate linear regression was used to evaluate the effects of liquid versus solid energy intake and different beverage types on changes in body mass index (BMI) Z-score from ages 8 to 11.5 years (△BMIz(8-11.5y)) and percentage body fat (%BF) at age 11.5 years (%BF(11.5y)). Substitution models were used to evaluate the effects of substituting other beverage types for sugar-sweetened beverages (SSB). RESULTS Liquid energy intake (1 MJ day(-1)) was more closely associated with both △BMIz(8-11.5y) (β = 0.23, P = 0.02) and %BF(11.5y) (β = 2.31%, P = 0.01) than solid energy intake (△BMIz(8-11.5y): β = 0.12, P = 0.01 and %BF(11.5y): β = 0.80%, P = 0.07). SSB consumption (100 g day(-1)) was directly associated with △BMIz(8-11.5y) (β = 0.08, P = 0.02) and %BF(11.5y) (β = 0.92%, P = 0.004),whereas diet drinks (100 g day(-1) ) were inversely associated with △BMIz(8-11.5y) (β = 0.18, P = 0.02). Substitution of 100 g of SSB by 100 g of water or diet drink, but not other beverages, was inversely associated with both △BMIz(8-11.5y) and %BF(11.5y) (P < 0.01). CONCLUSIONS Our findings indicate that liquid energy is more obesogenic than solid energy. In particular, SSB, but not other beverage types, are a significant predictor of childhood adiposity and replacing SSB with water can have long-term beneficial effects on childhood adiposity.
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Development of exchange lists for Mediterranean and Healthy Eating diets: implementation in an intervention trial.
Sidahmed, E, Cornellier, ML, Ren, J, Askew, LM, Li, Y, Talaat, N, Rapai, MS, Ruffin, MT, Turgeon, DK, Brenner, D, et al
Journal of human nutrition and dietetics : the official journal of the British Dietetic Association. 2014;(5):413-25
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BACKGROUND There has been little research published on the adaptation of diabetic exchange list diet approaches for the design of intervention diets in health research despite their clinical utility. The exchange list approach can provide clear and precise guidance on multiple dietary changes simultaneously. The present study aimed to develop exchange list diets for Mediterranean and Healthy Eating, and to evaluate adherence, dietary intakes and markers of health risks with each counselling approach in 120 subjects at increased risk for developing colon cancer. METHODS A randomised clinical trial was implemented in the USA involving telephone counselling. The Mediterranean diet had 10 dietary goals targeting increases in mono-unsaturated fats, n-3 fats, whole grains and the amount and variety of fruits and vegetables. The Healthy Eating diet had five dietary goals that were based on the US Healthy People 2010 recommendations. RESULTS Dietary compliance was similar in both diet arms, with 82-88% of goals being met at 6 months, although subjects took more time to achieve the Mediterranean goals than the Healthy Eating goals. The relatively modest fruit and vegetable goals in the Healthy Eating arm were exceeded, resulting in fruit and vegetable intakes of approximately eight servings per day in each arm after 6 months. A significant (P < 0.05) weight loss and a decrease in serum C-reactive protein concentrations were observed in the overweight/obese subgroup of subjects in the Mediterranean arm in the absence of weight loss goals. CONCLUSIONS Counselling for the Mediterranean diet may be useful for both improving diet quality and for achieving a modest weight loss in overweight or obese individuals.
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Is healthy eating for obese children necessarily more costly for families?
Banks, J, Williams, J, Cumberlidge, T, Cimonetti, T, Sharp, DJ, Shield, JP
The British journal of general practice : the journal of the Royal College of General Practitioners. 2012;(594):e1-5
Abstract
BACKGROUND During consultations on weight management in childhood obesity clinics, the additional costs incurred by healthy eating are often cited, as an economic barrier to achieving a better nutritional balance. AIM: To examine whether adopting an improved theoretical, balanced diet compared to current dietary habits in children incurs additional cost. DESIGN AND SETTING Children aged 5-16 years (body mass index [BMI] ≥98th percentile) recruited to a randomised trial comparing a hospital-based and primary care childhood obesity clinics provided data for this study. METHOD Three-day dietary diaries collected at baseline were analysed for energy and fat intake and then compared to a theoretical, adjusted healthy-eating diet based on the Food Standards Agency, 'Eatwell plate'. Both were priced contemporaneously using the appropriate portion size, at a neighbourhood, mid-range supermarket, at a budget supermarket, and on the local high street. RESULTS The existing diet purchased at a budget supermarket was cheapest (£2.48/day). The healthier, alternative menu at the same shop cost an additional 33 pence/day (£2.81). The same exercise in a mid-range supermarket, incurred an additional cost of 4 pence per day (£3.40 versus £3.44). Switching from an unhealthy mid-range supermarket menu to the healthier, budget-outlet alternative saved 59 pence per day. The healthier, alternative menu was cheaper than the existing diet if purchased on the high street (£3.58 versus £3.75), although for both menus this was most expensive. CONCLUSION For many obese children, eating healthily would not necessarily incur prohibitive, additional financial cost, although a poor diet at a budget supermarket remains the cheapest of all options. Cost is a possible barrier to healthy eating for the most economically disadvantaged.
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Health, wellbeing and nutritional status of older people living in UK care homes: an exploratory evaluation of changes in food and drink provision.
Kenkmann, A, Price, GM, Bolton, J, Hooper, L
BMC geriatrics. 2010;:28
Abstract
BACKGROUND Food and drink are important determinants of physical and social health in care home residents. This study explored whether a pragmatic methodology including routinely collected data was feasible in UK care homes, to describe the health, wellbeing and nutritional status of care home residents and assess effects of changed provision of food and drink at three care homes on residents' falls (primary outcome), anaemia, weight, dehydration, cognitive status, depression, lipids and satisfaction with food and drink provision. METHODS We measured health, wellbeing and nutritional status of 120 of 213 residents of six care homes in Norfolk, UK. An intervention comprising improved dining atmosphere, greater food choice, extended restaurant hours, and readily available snacks and drinks machines was implemented in three care homes. Three control homes maintained their previous system. Outcomes were assessed in the year before and the year after the changes. RESULTS Use of routinely collected data was partially successful, but loss to follow up and levels of missing data were high, limiting power to identify trends in the data. This was a frail older population (mean age 87, 71% female) with multiple varied health problems. During the first year 60% of residents had one or more falls, 40% a wound care visit, and 40% a urinary tract infection. 45% were on diuretics, 24% antidepressants, and 43% on psychotropic medication. There was a slight increase in falls from year 1 to year 2 in the intervention homes, and a much bigger increase in control homes, leading to a statistically non-significant 24% relative reduction in residents' rate of falls in intervention homes compared with control homes (adjusted rate ratio 0.76, 95% CI 0.57 to 1.02, p = 0.06). CONCLUSIONS Care home residents are frail and experience multiple health risks. This intervention to improve food and drink provision was well received by residents, but effects on health indicators (despite the relative reduction in falls rate) were inconclusive, partly due to problems with routine data collection and loss to follow up. Further research with more homes is needed to understand which, if any, components of the intervention may be successful.
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Food availability, neighborhood socioeconomic status, and dietary patterns among blacks with type 2 diabetes mellitus.
Millstein, RA, Yeh, HC, Brancati, FL, Batts-Turner, M, Gary, TL
Medscape journal of medicine. 2009;(1):15
Abstract
CONTEXT High diabetes prevalence among low-income and urban African American populations. OBJECTIVES & MAIN OUTCOME MEASURES This study aimed to determine associations between neighborhood-level food sources and socioeconomic status (SES), and dietary patterns and body-mass index (BMI). The hypotheses were that the presence of food stores in neighborhoods would be associated with better dietary habits and BMI, and that the presence of convenience stores, and lower neighborhood SES, would be associated with poorer dietary habits and BMI. DESIGN, SETTING, & PATIENTS Black adults (n = 132) with type 2 diabetes in Project Sugar 2 (Baltimore, Maryland) underwent the Ammerman dietary assessment: total dietary risk score and subscores for meat, dairy, starches, and added fat. Food source availability (food stores, convenience stores, other food stores, restaurants, and other food service places) and SES data from the 2000 US census at the tract-level were linked to individual-level data. Linear mixed-effects regression models with random intercepts were used to account for neighborhood clustering and for individual-level SES and potential confounders. RESULTS The presence of restaurants and other food service places in census tracts were associated with better dietary patterns (adjusted added fat subscore beta = -1.1, 95% confidence interval [CI] = -1.8, -0.4, and beta = -1.0, 95% CI = -1.7, -0.3, respectively). The presence of convenience stores and lower neighborhood SES was not significantly associated with worse dietary patterns or body-mass index, although trends were in the hypothesized direction. CONCLUSIONS These findings provide some evidence for structural improvements to food environments in urban and low-income black neighborhoods.
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[Effect of healthy school meal on selection of blood parameters].
Horn, PB, Brandslund, I, Schmedes, A, Thygesen, K, Hey, H
Ugeskrift for laeger. 2009;(26):2174-9
Abstract
INTRODUCTION It was tested if a healthy school meal would result in significant changes in selected blood parameters and if such parameters would lie within generally accepted optimal values. MATERIAL AND METHODS The study was a block-randomized, controlled trial in which 145 pupils delivered blood before (week 39) and after the intervention (week 49). The intervention group received a healthy meal for two months (25-30% of the daily intake of calories). Blood samples were analyzed for 17 parameters related to carbohydrate, fat and protein metabolism as well as vitamins and minerals. RESULTS During the intervention period, the intervention group showed a significant change in mean values for thyroid-stimulating hormone (TSH), calcium (CA) haemoglobin (HB), cobalamin (COBA) and creatinine (CREA) compared with the control group (p < 0.025). The optimal value for vitamin D in serum is about 80 nmol/l. In week 49, more than 94% of the pupils were lower than 80 nmol/l, and they generally had low calcium values. CONCLUSION The intervention group showed significant alterations in TSH, CA, HB, COBA and CREA values from the start to the end of the intervention period compared with the control group. The results should be confirmed in a study with more participants over a longer period of time. The teenagers in the study did not have sufficient vitamin D. Treating adolescents with a daily dose of vitamin D should be considered .
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Effect of food on the antiviral activity of didanosine enteric-coated capsules: a pilot comparative study.
Hernández-Novoa, B, Antela, A, Gutiérrez, C, Pérez-Molina, JA, Pérez-Elías, MJ, Dronda, F, Moreno, A, Casado, JL, Page, C, Pumares, M, et al
HIV medicine. 2008;(4):187-91
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OBJECTIVES To determine the effect of food on the antiviral activity of enteric-coated (EC) capsules of didanosine (ddI). METHODS We conducted a pilot, randomized, open-label study of 28-day ddI-EC capsules monotherapy-administered in a fasted state (group 1, n=11) or with food (group 2, n=10) to treatment-naïve chronically HIV-1-infected individuals. To assess the antiviral efficacy, HIV-1 RNA was determined at baseline, day 3, day 7 and weekly thereafter. The area under the HIV-1 RNA curve minus baseline weighted by time (AUCMB/day) was calculated. RESULTS Mean baseline HIV-1 RNA was 4.2 log(10) copies/mL in group 1 and 3.8 log(10) copies/mL in group 2. After 28 days, the mean HIV-1 RNA reduction was 0.99 log(10) copies/mL [95% confidence interval (CI) 0.45-1.53] for group 1 and 0.89 log(10) copies/mL (95% CI 0.38-1.40) for group 2. AUCMB/day values were 0.775 log(10) copies/mL (95% CI 0.33-1.22) and 0.774 log(10) copies/mL (95% CI 0.48-1.07), respectively, showing no difference in the rate of decrease of HIV-1 RNA (P=0.995). Mean ddI plasma levels at day 28 were 0.0234 mg/L for group 1 and 0.0227 mg/L for group 2 (P=0.96). CONCLUSIONS In this pilot study, the administration of food did not have any significant effect on the antiviral activity of ddI-EC capsules.