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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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Reintroduction failure after negative food challenges in adults is common and mainly due to atypical symptoms.
Versluis, A, Knulst, AC, van Erp, FC, Blankestijn, MA, Meijer, Y, Le, TM, van Os-Medendorp, H
Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology. 2020;(4):479-486
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BACKGROUND Reintroduction of a food after negative food challenge (FC) faces many obstacles. There are no studies available about this subject in adults. OBJECTIVE To investigate the frequency, reasons and risk factors of reintroduction failure in adults. METHODS In this prospective study, adult patients received standardized follow-up care after negative FCs including a reintroduction scheme and supportive telephone consultations. Data were collected by telephone interview (2 weeks after FC) and questionnaires (at baseline and 6 months after FC(s)): food habits questionnaire, State-Trait Anxiety Inventory, Food Allergy Quality of Life Questionnaire-Adult Form and Food Allergy Independent Measure. Frequency and reasons of reintroduction failure were analysed using descriptive statistics and risk factors with univariate analyses. RESULTS Eighty patients were included with, in total, 113 negative FCs. Reintroduction failed on short-term (2 weeks after FC) in 20% (95% CI: 13%-28%). Common reasons were symptoms upon ingestion during the reintroduction scheme (50%) and no need to eat the food (23%). On the long-term (5-12 months after FC(s)), reintroduction failure increased to 40% (95% CI: 28%-53%). Common reasons were atypical symptoms after eating the food (59%) and fear for an allergic reaction (24%). Five risk factors for long-term reintroduction failure were found: if culprit food was not one of the 13 EU regulated allergens, reintroduction failure at short-term, atypical symptoms during FC, a lower quality of life and a higher state anxiety. CONCLUSIONS AND CLINICAL RELEVANCE Reintroduction failure after negative FCs in adults is common, increases over time, and is primarily due to atypical symptoms. This stresses the need for more patient-tailored care before and after negative food challenges.
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Changes in Food Cravings and Eating Behavior after a Dietary Carbohydrate Restriction Intervention Trial.
Anguah, KO, Syed-Abdul, MM, Hu, Q, Jacome-Sosa, M, Heimowitz, C, Cox, V, Parks, EJ
Nutrients. 2019;(1)
Abstract
Compared to low-fat diets, low-carbohydrate (CHO) diets cause weight loss (WL) over a faster time frame; however, it is unknown how changes in food cravings and eating behavior contribute to this more rapid WL in the early phases of dieting. We hypothesized that reductions in food cravings and improved eating behaviors would be evident even after a relatively short (4-week) duration of CHO-restriction, and that these changes would be associated with WL. Adult participants (n = 19, 53% males, mean ± SD: BMI = 34.1 ± 0.8 kg/m2; age 40.6 ± 1.9 years) consumed a CHO-restricted diet (14% CHO, 58% fat, 28% protein) for 4 weeks. Before and after the intervention, specific and total cravings were measured with the Food Craving Inventory (FCI) and eating behaviors assessed with the Three-Factor Eating questionnaire. Food cravings were significantly reduced at week 4, while women had significantly greater reductions in sweet cravings than men. Dietary restraint was significantly increased by 102%, while disinhibiton and hunger scores were reduced (17% and 22%, respectively, p < 0.05). Changes in cravings were unrelated to changes in body weight except for the change in high-fat cravings where those who lost the most weight experienced the least reductions in fat cravings (r = -0.458, p = 0.049). Changes in dietary restraint were inversely related to several FCI subscales. A short-term, low-CHO diet was effective in reducing food cravings. These data suggest that in subjects that have successfully lost weight on a low-CHO diet, those who craved high-fat foods at the onset were able to satisfy their cravings-potentially due to the high-fat nature of this restricted diet.
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The Inflammatory Potential of Dietary Manganese in a Cohort of Elderly Men.
Kresovich, JK, Bulka, CM, Joyce, BT, Vokonas, PS, Schwartz, J, Baccarelli, AA, Hibler, EA, Hou, L
Biological trace element research. 2018;(1):49-57
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Manganese is an essential nutrient that may play a role in the production of inflammatory biomarkers. We examined associations between estimated dietary manganese intake from food/beverages and supplements with circulating biomarkers of inflammation. We further explored whether estimated dietary manganese intake affects DNA methylation of selected genes involved in the production of these biomarkers. We analyzed 1023 repeated measures of estimated dietary manganese intakes and circulating blood inflammatory biomarkers from 633 participants in the Normative Aging Study. Using mixed-effect linear regression models adjusted for covariates, we observed positive linear trends between estimated dietary manganese intakes and three circulating interleukin proteins. Relative to the lowest quartile of estimated intake, concentrations of IL-1β were 46% greater (95% CI - 5, 126), IL-6 52% greater (95% CI - 9, 156). and IL-8 32% greater (95% CI 2, 71) in the highest quartiles of estimated intake. Estimated dietary manganese intake was additionally associated with changes in DNA methylation of inflammatory biomarker-producing genes. Higher estimated intake was associated with higher methylation of NF-κβ member activator NKAP (Q4 vs Q1: β = 3.32, 95% CI - 0.6, 7.3). When stratified by regulatory function, higher manganese intake was associated with higher gene body methylation of NF-κβ member activators NKAP (Q4 vs Q1: β = 10.10, 95% CI - 0.8, 21) and NKAPP1 (Q4 vs Q1: β = 8.14, 95% CI 1.1, 15). While needed at trace amounts for various physiologic functions, our results suggest estimated dietary intakes of manganese at levels slightly above nutritional adequacy contribute to inflammatory biomarker production.
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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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Effect of texture of plastic and elastic model foods on the parameters of mastication.
Foster, KD, Woda, A, Peyron, MA
Journal of neurophysiology. 2006;(6):3469-79
Abstract
Mastication is continually modified throughout the chewing sequence in response to the texture of the food. The aim of this work was to compare the effects of an increase in hardness of two model food types, presenting either elastic or plastic rheological properties, on mastication. Each model food type consisted of four products of different hardness. Sensory testing experiments conducted with one group of 14 subjects showed significant perceived differences between products in terms of their increasing hardness. Fifteen other volunteers were asked to chew three replicates of each elastic and plastic product during two sessions. EMGs of masseter and temporalis muscles were recorded simultaneously with jaw movement during chewing. Numerous variables were analyzed from these masticatory recordings. Multiple linear regression analyses were used to assess the respective effects of food hardness and rheological properties on variables characterizing either the whole masticatory sequence or different stages of the sequence. Muscle activities were significantly affected by an increase in hardness regardless of the food type, whereas the shape of the cycles depended on the rheological properties. The masticatory frequency was affected by hardness at the initial stage of the sequence but overall frequency adaptation was better explained by a change in rheological behavior, with plastic products being chewed at a slower frequency. A dual hypothesis was proposed, implicating first a cortical-brain stem preprogrammed mechanism to adapt the shape of the jaw movements to the rheological properties of the food, and second, a brain stem mechanism with mainly sensory feedback from the mouth to adapt muscle force to the food hardness.