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Clinical Pharmacology in Drug... Aug 2021Food reduces tacrolimus bioavailability after immediate-release tacrolimus (IR-Tac) and after a new prolonged-release tacrolimus formulation (PR-Tac), when using a... (Randomized Controlled Trial)
Randomized Controlled Trial
Food reduces tacrolimus bioavailability after immediate-release tacrolimus (IR-Tac) and after a new prolonged-release tacrolimus formulation (PR-Tac), when using a high-fat breakfast, but the effects of a continental breakfast on PR-Tac are unknown. In an open-label, 4-phase, randomized, 2-sequence, crossover pharmacokinetic trial, 36 healthy volunteers (18 females) received single 5-mg tacrolimus doses as PR-Tac and as IR-Tac fasted or with a standardized continental breakfast. Tacrolimus pharmacokinetics were analyzed using noncompartmental methods and mixed-model analysis of variance. The continental breakfast significantly decreased average tacrolimus exposure (area under the plasma concentration-time curve) with both preparations (IR-Tac, 67%; 90% confidence interval [CI], 59%-75%; P < .01; and PR-Tac, 79%; 90%CI, 70%-89%; P < .01) with a nonsignificant difference between both preparations (P = .10). The maximum concentration (C ) and the time to maximum concentration (t ) were significantly affected only after IR-Tac (C IR-Tac, 39%; 90%CI, 34%-45%; P < .01; and PR-Tac, 87%; 90%CI, 76%-101%; P = .11; t IR-Tac, 212%, 90%CI, 179%-252%; P < .01; and PR-Tac, 101%; 90%CI, 86%-120%; P = .89), which was significantly different between both preparations (P < .01). Considering switching from IR-Tac to PR-Tac, predicted dose requirements differed according to the timing of drug intake in relation to food. In conclusion, a continental breakfast decreased average tacrolimus exposure of both preparations to a similar extent. C and t were affected only after IR-Tac. The effect of a standardized continental breakfast on PR-Tac was considerably smaller than previously reported effects of a high-fat breakfast on PR-Tac.
Topics: Adult; Area Under Curve; Breakfast; Cross-Over Studies; Drug Administration Schedule; Drug Compounding; Female; Food-Drug Interactions; Humans; Male; Tacrolimus; Young Adult
PubMed: 33641238
DOI: 10.1002/cpdd.924 -
PloS One 2023Inorganic nitrate has been shown to acutely improve working memory in adults, potentially by altering cerebral and peripheral vasculature. However, this remains unknown...
Acute effects of nitrate and breakfast on working memory, cerebral blood flow, arterial stiffness, and psychological factors in adolescents: Study protocol for a randomised crossover trial.
BACKGROUND
Inorganic nitrate has been shown to acutely improve working memory in adults, potentially by altering cerebral and peripheral vasculature. However, this remains unknown in adolescents. Furthermore, breakfast is important for overall health and psychological well-being. Therefore, this study will investigate the acute effects of nitrate and breakfast on working memory performance, task-related cerebral blood flow (CBF), arterial stiffness, and psychological outcomes in Swedish adolescents.
METHODS
This randomised crossover trial will recruit at least 43 adolescents (13-15 years old). There will be three experimental breakfast conditions: (1) none, (2) low-nitrate (normal breakfast), and (3) high-nitrate (concentrated beetroot juice with normal breakfast). Working memory (n-back tests), CBF (task-related changes in oxygenated and deoxygenated haemoglobin in the prefrontal cortex), and arterial stiffness (pulse wave velocity and augmentation index) will be measured twice, immediately after breakfast and 130 min later. Measures of psychological factors and salivary nitrate/nitrite will be assessed once before the conditions and at two-time points after the conditions.
DISCUSSION
This study will provide insight into the acute effects of nitrate and breakfast on working memory in adolescents and to what extent any such effects can be explained by changes in CBF. This study will also shed light upon whether oral intake of nitrate may acutely improve arterial stiffness and psychological well-being, in adolescents. Consequently, results will indicate if nitrate intake from beetroot juice or if breakfast itself could acutely improve cognitive, vascular, and psychological health in adolescents, which can affect academic performance and have implications for policies regarding school meals.
TRIAL REGISTRATION
The trial has been prospectively registered on 21/02/2022 at https://doi.org/10.1186/ISRCTN16596056. Trial number: ISRCTN16596056.
Topics: Adult; Humans; Adolescent; Nitrates; Breakfast; Cross-Over Studies; Vascular Stiffness; Memory, Short-Term; Pulse Wave Analysis; Cerebrovascular Circulation; Beta vulgaris; Blood Pressure; Dietary Supplements; Randomized Controlled Trials as Topic
PubMed: 37205681
DOI: 10.1371/journal.pone.0285581 -
Medicina (Kaunas, Lithuania) Aug 2020Recently, the prevalence of metabolic syndrome in Korea has increased rapidly. Current knowledge reflects the importance of dietary control in relation to the metabolic...
Recently, the prevalence of metabolic syndrome in Korea has increased rapidly. Current knowledge reflects the importance of dietary control in relation to the metabolic syndrome. The objective of this study was to evaluate the influence of skipping breakfast on the metabolic syndrome. We conducted a cross-sectional study using data from the Korea National Health and Nutrition Examination Survey 2017 for the second year. A total of 3864 adults aged 20 to 64 were included in the study. We stratified the study population into three groups, based on breakfast patterns: the regular group, irregular group, and skipping group. Multiple logistic regression analysis was used to analyze the association between skipping breakfast and the presence of metabolic syndrome. We noted an increase in the proportion of metabolic syndrome cases as follows: skipping group (3.3%), irregular group (5.4%), and regular group (8.5%) ( < 0.001). The multivariate-adjusted odds ratios of metabolic syndrome in the skipping and irregular groups compared with the regular group were 0.68 (95% CI; 0.35 to 1.35) and 0.81 (95% CI; 0.51 to 1.28), respectively. In the 40-65-year-old age group, which had a high prevalence of metabolic syndrome, the multivariate-adjusted odds ratios of metabolic syndrome in the skipping group compared with regular group were 0.78 (95%CI, 0.39 to 1.62). There was no significant correlation between skipping breakfast and risk factors of metabolic syndrome (after adjusting for risk factors), but a tendency of skipping breakfast to lower the risk of metabolic syndrome was observed. A rationale for these results is proposed through the association between skipping breakfast and intermittent fasting.
Topics: Adult; Breakfast; Correlation of Data; Cross-Sectional Studies; Fasting; Female; Humans; Male; Metabolic Syndrome; Middle Aged; Nutrition Surveys; Republic of Korea; Risk Factors
PubMed: 32784810
DOI: 10.3390/medicina56080396 -
The American Journal of Occupational... Mar 2024Impaired self-awareness (SA) of deficits after an acquired brain injury (ABI) severely affects patients' independence in activities of daily living (ADLs). However, any...
IMPORTANCE
Impaired self-awareness (SA) of deficits after an acquired brain injury (ABI) severely affects patients' independence in activities of daily living (ADLs). However, any assessment tool permits an exhaustive evaluation of SA in the context of ADLs.
OBJECTIVE
To study the validity of the Breakfast and Dressing Conflict Task (BD Conflict Task) to assess online SA (awareness of performance in the context of a given task) in patients with ABI; to study its interactions with offline SA (general awareness); and to test the validity of a simplified measure of performance monitoring, the ADL Conflict-Monitoring Index.
DESIGN
Convergent validity and correlational study.
SETTING
Research laboratory, hospitals, and homes.
PARTICIPANTS
Thirty patients with ABI and 28 neurologically healthy controls.
OUTCOMES AND MEASURES
Using the BD Conflict Task, measures of emergent awareness, self-regulation, anticipatory awareness, and self-evaluation were assessed and their convergent validity and relationship with offline SA were analyzed. The ADL Conflict-Monitoring Index was calculated, and its convergent validity was tested.
RESULTS
The online SA variables of the BD Conflict Task showed convergent validity with traditional online SA measures. Offline SA correlated with emergent and anticipatory awareness in the Breakfast Task. The ADL Conflict-Monitoring Index proved to be a valid measure of patients' performance monitoring.
CONCLUSIONS AND RELEVANCE
These preliminary findings suggest that the BD Conflict Task is a valid tool to assess online SA in patients with ABI and provide further understanding of the online SA-offline SA interaction. Furthermore, the ADL Conflict-Monitoring Index may be a valid and easy-to-use monitoring measure in clinical settings. Plain-Language Summary: Patients with acquired brain injury (ABI) and reduced awareness of their cognitive deficits face problems performing activities of daily living (ADLs) and may show signs of unsafe behaviors. Being aware of one's own abilities involves anticipating problems before starting a task, detecting and correcting errors during the task, and evaluating performance afterward. This study provides preliminary validity for the Breakfast and Dressing Conflict Task, a new tool that assesses aspects of self-awareness simultaneously in the context of familiar and significant ADLs. Furthermore, the tool simplifies the assessment of detecting and correcting errors with an easy-to-use index, making it suitable for use in clinical settings.
Topics: Humans; Activities of Daily Living; Breakfast; Perception; Bandages; Brain Injuries
PubMed: 38477680
DOI: 10.5014/ajot.2024.050346 -
Scientific Reports Oct 2023Skipping breakfast is highly prevalent but it is not clear whether breakfast frequency is associated with metabolic syndrome in young adults. We aimed to assess the...
Skipping breakfast is highly prevalent but it is not clear whether breakfast frequency is associated with metabolic syndrome in young adults. We aimed to assess the association between breakfast frequency and metabolic syndrome in Korean young adults. This cross-sectional study was based on health check-up data of university students aged 18-39 years between 2016 and 2018. Participants were stratified into three groups by breakfast frequency (non-skipper, skipper 1-3 days/week, skipper 4-7 days/week). Multivariable-adjusted logistic regression was used to calculate odds ratios (ORs) and 95% confidence intervals (CIs) of metabolic syndrome. Out of 12,302 participants, 56.8% skipped breakfast at least 4 days/week. Metabolic syndrome prevalence was higher in those skipping breakfast for 4 or more days/week compared to non-skipper. (3.1% vs 1.7%) In the age- and sex-adjusted model, individuals skipping breakfast for 4-7 days per week had a higher OR of metabolic syndrome (OR 1.73, 95% CI 1.21-2.49) compared to non-skipper. Although this association became insignificant (OR 1.49, 95% CI 0.99-2.23) after a fully adjusted multivariable model, trends of positive association between frequency of breakfast skipping and metabolic syndrome was significant (P for trend = 0.038). Frequent breakfast skipping was associated with higher odds of metabolic syndrome in young adults. Further longitudinal studies in the long term are needed to understand the association of meal patterns with metabolic syndrome.
Topics: Humans; Young Adult; Breakfast; Metabolic Syndrome; Cross-Sectional Studies; Feeding Behavior; Longitudinal Studies
PubMed: 37803107
DOI: 10.1038/s41598-023-43957-3 -
International Journal of Environmental... Aug 2020The type of food eaten for breakfast may determine the amount of food consumed at the next meal. This may be important when considering dietary advice for overweight and...
The type of food eaten for breakfast may determine the amount of food consumed at the next meal. This may be important when considering dietary advice for overweight and obese individuals who are trying to lose weight. The aim of the study was to investigate the energy intake and subjective sensations of hunger using a visual analogue scale (VAS) of a breakfast meal of eggs compared with a breakfast meal of cereal in overweight Australian adults. In a cross-over study, participants attended the University of South Australia's Clinical Trial Facility on two separate days, one week apart. On each day participants consumed one of two isoenergetic breakfasts (1800 kJ), either eggs and toast or cereal with milk and orange juice. Fifty overweight or obese participants, 44 ± 21 years, 86 ± 14 kg, with a body mass index (BMI) of 31 ± 4 kg/m completed both study visits. Energy intake following the egg breakfast was significantly reduced compared with the cereal breakfast (4518 vs. 5283 kJ, = 0.001). BMI and gender were unrelated to these effects. The sensation of hunger was less after the egg breakfast ( = 0.028 for diet by time interaction) and returned more quickly after the cereal breakfast. There were no effects of gender or age. Energy intake was reduced at an ad libitum lunch meal 4 hours after a breakfast meal containing eggs. The findings suggest that satiety responses of overweight and obese are not different to non-obese participants as our study confirms findings from studies conducted in different populations. Determining which foods may help overweight and obese individuals manage their food intake is important for diet planning.
Topics: Adult; Australia; Breakfast; Cross-Over Studies; Eggs; Energy Intake; Female; Humans; Male; Obesity; Overweight; Satiation; Satiety Response
PubMed: 32756313
DOI: 10.3390/ijerph17155583 -
The British Journal of Nutrition Jul 2023Few studies examined the association of energy, macronutrients and food consumption at dinner . breakfast with hypercholesterolaemia. A total of 27 911 participants...
Few studies examined the association of energy, macronutrients and food consumption at dinner . breakfast with hypercholesterolaemia. A total of 27 911 participants from the National Health and Nutrition Examination Survey (2003-2016) were included in the cross-sectional study. Energy, macronutrients and food consumption at breakfast, dinner and the difference at dinner . breakfast (Δratio) were calculated. Multiple logistic regression models and substitution effects of foods at dinner with breakfast were also performed. After adjustment for potential covariates, compared with the lowest quintile, participants in the highest quintile of Δratio in terms of energy had a higher risk of prevalent hypercholesterolaemia (OR 1·16, 95 % CI (1·01, 1·33)) mainly due to Δratio of low-quality carbohydrates and plant protein (OR 1·19; 95 % CI (1·05, 1·35)); OR 1·13; 95 % CI (1·01, 1·28)). ΔAdded sugars and Δnuts were associated with hypercholesterolaemia (OR 1·01; 95 % CI (1·00, 1·02)); OR 1·08; 95 % CI (1·01, 1·16)). Furthermore, the substitution of added sugars, nuts and processed meat at dinner with breakfast could reduce the OR of hypercholesterolaemia. This study indicated that among US adults, overconsumption of energy, macronutrients including low-quality carbohydrates and plant protein at dinner than breakfast was significantly associated with a higher risk of prevalent hypercholesterolaemia. The replacing of added sugar, nuts and processed meat at dinner with breakfast reduced the risk of prevalent hypercholesterolaemia. This study emphasised the importance of meal timing in the prevention of hypercholesterolaemia.
Topics: Humans; Adult; Diet; Nutrition Surveys; Hypercholesterolemia; Cross-Sectional Studies; Meals; Breakfast; Nutrients; Carbohydrates; Sugars; Energy Intake; Feeding Behavior
PubMed: 36597806
DOI: 10.1017/S0007114522003257 -
Nutrients Jan 2021Research is limited on added sugars in school meals and children's dietary intakes after the 2015-2020 Dietary Guidelines for Americans (DGA) recommended that added...
Research is limited on added sugars in school meals and children's dietary intakes after the 2015-2020 Dietary Guidelines for Americans (DGA) recommended that added sugars be limited to less than 10% of total calories. This analysis uses data from the School Nutrition and Meal Cost Study (SNMCS) to examine levels of added sugars in: (1) school meals and (2) children's dietary intakes at breakfast, lunch, and over 24 h on school days. SNMCS data were collected in the 2014-2015 school year after updated nutrition standards for school meals were implemented. Most schools exceeded the DGA limit for added sugars at breakfast (92%), while 69% exceeded the limit at lunch. The leading source of added sugars in school meals (both breakfasts and lunches) was flavored skim milk. More than 62% of children consumed breakfasts that exceeded the DGA limit, and almost half (47%) consumed lunches that exceeded the limit. Leading sources of added sugars in the breakfasts consumed by children were sweetened cold cereals and condiments and toppings; leading sources of added sugars in children's lunches were flavored skim milk and cake. Over 24 h, 63% of children exceeded the DGA limit. These findings show that school meals and children's dietary intakes are high in added sugars relative to the DGA limit and provide insights into the types of foods that should be targeted in order to decrease levels of added sugars.
Topics: Child; Diet; Diet Surveys; Dietary Sugars; Food Services; Guideline Adherence; Humans; Nutrition Policy; Schools; United States
PubMed: 33573299
DOI: 10.3390/nu13020471 -
The International Journal of Behavioral... Nov 2018Evidence from experimental and observational studies is limited regarding the most favorable breakfast composition to prevent abdominal fat accumulation. We explored the...
BACKGROUND
Evidence from experimental and observational studies is limited regarding the most favorable breakfast composition to prevent abdominal fat accumulation. We explored the association between breakfast composition (a posteriori derived dietary patterns) and abdominal obesity among regular breakfast eaters from a Swiss population-based sample.
METHODS
The cross-sectional survey assessed diet using two 24-h dietary recalls in a nationally representative sample of adults aged 18 to 75 years. We derived dietary patterns using principal component analysis based on the intake of 22 breakfast-specific food groups. All regular breakfast eaters were predicted an individual score for each identified pattern, and then classified into tertiles (T1, T2, T3). We defined abdominal obesity as waist-to-hip ratio (WHR) ≥ 0.9 in men and ≥ 0.85 in women. Logistic models were adjusted for sociodemographic characteristics, relevant nutrition- and health-related behaviors, and diet quality during the rest of the day.
RESULTS
Of the 2019 included survey participants, 1351 (67%) were regular breakfast eaters. Among them, we identified three breakfast types: 1) 'traditional' - white bread, butter, sweet spread, 2) 'prudent' - fruit, unprocessed and unsweetened cereal flakes, nuts/seeds, yogurt, and 3) 'western' - processed breakfast cereals, and milk. The 'prudent' breakfast was negatively associated with abdominal obesity. After full adjustment, including diet quality during the rest of the day, the association was weaker (T3 vs. T1: OR 0.72, 95% CI: 0.47 to 1.08). People taking a 'prudent' breakfast (in T3) had 1.2% lower WHR compared to people taking a breakfast distant from 'prudent' (in T1) (P = 0.02, fully adjusted model with continuous log-WHR). We found no association between 'traditional' or 'western' breakfasts and WHR (OR 1.00, 95% CI: 0.67 to 1.50 and OR 1.16, 95% CI: 0.79 to 1.71, respectively). Findings were in the same directions for the three breakfast types when defining obesity with waist circumference, waist-to-height ratio, or body mass index (≥ 30 kg/m, for 'prudent' breakfast: OR 0.51, 95% CI: 0.31 to 0.85).
CONCLUSIONS
Regular breakfast consumers had less abdominal obesity if their breakfast was composed of fruit, natural cereal flakes, nuts/seeds and yogurt. This association was partly explained by their healthier diet during the rest of the day.
TRIAL REGISTRATION
ISRCTN16778734 .
Topics: Adolescent; Adult; Aged; Body Mass Index; Breakfast; Cross-Sectional Studies; Diet, Healthy; Dietary Fiber; Female; Humans; Male; Middle Aged; Obesity, Abdominal; Principal Component Analysis; Switzerland; Waist Circumference; Waist-Hip Ratio; Young Adult
PubMed: 30458811
DOI: 10.1186/s12966-018-0752-7 -
Birth (Berkeley, Calif.) Mar 2022There is a lack of consensus in the literature about the association between meal patterning during pregnancy and birth outcomes. This study examined whether maternal...
BACKGROUND
There is a lack of consensus in the literature about the association between meal patterning during pregnancy and birth outcomes. This study examined whether maternal meal patterning in the week before birth was associated with an increased likelihood of imminent spontaneous labor.
METHODS
Data came from 607 participants in the third phase of the Pregnancy, Infection, and Nutrition Study (PIN3). Data were collected through an interviewer-administered questionnaire after birth, before hospital discharge. Questions included the typical number of meals and snacks consumed daily, during both the week before labor onset and the 24-hour period before labor onset. A self-matched, case-crossover study design examined the association between skipping one or more meals and the likelihood of spontaneous labor onset within the subsequent 24 hours.
RESULTS
Among women who experienced spontaneous labor, 87.0% reported routinely eating three daily meals (breakfast, lunch, and dinner) during the week before their labor began, but only 71.2% reported eating three meals during the 24-hour period before their labor began. Compared with the week before their labor, the odds of imminent spontaneous labor were 5.43 times as high (95% CI: 3.41-8.65) within 24 hours of skipping 1 or more meals. The association between skipping 1 or more meals and the onset of spontaneous labor remained elevated for both pregnant individuals who birthed early (37-<39 weeks) and full-term (≥39 weeks).
CONCLUSIONS
Skipping meals later in pregnancy was associated with an increased likelihood of imminent spontaneous labor, though we are unable to rule out reverse causality.
Topics: Breakfast; Cross-Over Studies; Family; Feeding Behavior; Female; Humans; Male; Meals; Pregnancy
PubMed: 34453454
DOI: 10.1111/birt.12583