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Nutrients Sep 2023Overweight and obesity have increased rapidly in the past few decades in China, and less research has focused on the association between the consumption of...
Overweight and obesity have increased rapidly in the past few decades in China, and less research has focused on the association between the consumption of ultra-processed foods (UPFs) and overweight or obesity in Chinese adults. The objective of this study was to determine the relationship of UPF consumption with the risk of overweight or obesity in Chinese adults. Residents aged 18 years and above who participated in the nationally representative survey Chinese Food Consumption Survey in 2017-2020 were included in this study. Dietary intake data were collected via non-consecutive three-day 24 h dietary recalls and weighing household foods and condiments. According to the NOVA food classification system, UPFs were classified depending on the purpose and extent of food processing. Multiple logistic regression and multivariate-adjusted restricted cubic spline (RCS) regressions were performed to estimate the association between UPF consumption (categorized into quartiles: quartile 1 (Q1), quartile 2 (Q2), quartile 3 (Q3), and quartile 4 (Q4)) and risk of overweight or obesity. A total of 38,658 adults aged 18 years and above participated in the present study. The prevalence of overweight and obesity in adults was 33.0% (95% CI: 32.91-33.10) and 9.6% (95% CI 9.55-9.67), respectively. After a multivariable adjustment, the risk of overweight or obesity was increased by 10% in Q3 (OR: 1.10, 95% CI: 1.04-1.17) compared to Q1 as a reference. Women (OR: 1.10, 95% CI: 1.01-1.20) and adults living in small and medium-sized cities (OR: 1.13, 95% CI: 1.01-1.26) with higher UPF consumption had higher odds of overweight or obesity. Nevertheless, the effect of higher UPF consumption on the risk of overweight or obesity was relatively weak for overall adults in China. The top three categories of subgroups consumption of UPFs were 1: sugar-sweetened beverages; 2: sauces, cheeses, spreads, and gravies; and 3: ultra-processed breads and breakfast cereals. These findings provide evidence that higher UPF consumption was positively associated with overweight or obesity, which was defined based on Chinese criteria among women and adults living in small and medium-sized cities in China. Further studies, such as intervention trials, are needed to identify the mechanism of correlation between the consumption of UPFs and health-related outcomes in Chinese adults. From a public health perspective, with the prevalence of overweight and obesity growing and the increase in UPF consumption in Chinese adults, it is necessary to promote healthy food intake and a balanced diet through active nutritional education actions for overweight and obesity prevention and control.
PubMed: 37764788
DOI: 10.3390/nu15184005 -
Scandinavian Journal of Child and... Jan 2023A modified-release dexamphetamine sulfate formulation (DEX-MR) is under development for the treatment of attention-deficit/hyperactivity disorder.
Pharmacokinetics of a Modified-Release Dexamphetamine Sulfate Formulation Following Single and Multiple Dosing in Healthy Adults: Comparative Bioavailability with Immediate-Release Dexamphetamine Sulfate, between Strengths, Assessment of Food and Meal Composition Effects.
BACKGROUND
A modified-release dexamphetamine sulfate formulation (DEX-MR) is under development for the treatment of attention-deficit/hyperactivity disorder.
OBJECTIVE
We investigated the bioequivalence of once-daily DEX-MR to twice-daily immediate-release dexamphetamine sulfate (DEX-IR) after single and multiple dosing and between strengths, and effects of food and meal types.
METHOD
Three randomized, open-label, crossover studies in healthy males were conducted. In the single-dose study, participants received DEX-MR 20 mg, DEX-MR 10 mg (20 mg dose), and twice-daily DEX-IR 10 mg under fasted conditions and after a high-fat, high-calorie breakfast. In the breakfast study, participants received DEX-MR 20 mg and twice-daily DEX-IR 10 mg after a normocaloric and a high-fat, high-calorie breakfast. In the multiple-dose study, participants received DEX-MR 20 mg and twice-daily DEX-IR 10 mg for seven days each. In the run-in period (five days), participants consumed a normocaloric breakfast; on profile days, participants consumed a normocaloric breakfast (day 6) or a high-fat, high-calorie breakfast (day 7).
RESULTS
Once-daily DEX-MR at a dose of 20 mg was bioequivalent to twice-daily DEX-IR 10 mg after single dosing under fasted and fed conditions and after multiple dosing under fed conditions. DEX-MR 10 mg and DEX-MR 20 mg were bioequivalent when administered as a single 20 mg dose. Food slightly reduced the rate and extent of absorption of DEX-MR and delayed the time to peak plasma concentration () by approximately two hours compared to the fasted state. Bioavailability of DEX-MR was comparable under different meal conditions (normocaloric vs. high-fat, high-calorie breakfast) both after single and multiple dosing.
CONCLUSIONS
Bioequivalence of once-daily DEX-MR and twice-daily DEX-IR was established. 1×2 DEX-MR 10 mg was bioequivalent to 1×1 DEX-MR 20 mg. DEX-MR should be administered with/after a meal to achieve the targeted pharmacokinetic profile (delayed ). Bioavailability of DEX-MR is not affected by meal composition (i.e., fat and caloric content).
PubMed: 38033826
DOI: 10.2478/sjcapp-2023-0014 -
Frontiers in Nutrition 2023Women's nutrition should be different from that of men. Women have lower energy requirements than men. And the need for certain vitamins and minerals is higher in women,...
BACKGROUND
Women's nutrition should be different from that of men. Women have lower energy requirements than men. And the need for certain vitamins and minerals is higher in women, this applies to iron, calcium, magnesium, vitamin D and vitamin B9 (folic acid). This is related to hormonal changes including menstruation, pregnancy, breastfeeding and the onset of menopause. Through hormonal changes and the changing physiological state, women are at greater risk of anaemia, bone weakness and osteoporosis.The aim of the study was to assess changes in the dietary pattern among women from the Silesian Agglomeration in Poland between 2011 and 2022.
MATERIAL AND METHOD
The survey was conducted in 2011 (March-May 2011) and in 2022 (October-November 2022) among women living in the Silesian Agglomeration (Silesia region) in Poland aged 20-50. After consideration of the inclusion and exclusion criteria, 745 women were included in the final analysis, including 437 women screened in 2011 and 308 women screened in 2022.The research tool used in this publication was a survey questionnaire consisting of 2 parts. The first part of the questionnaire consisted of demographic data. The second part of the study focused on the dietary habits of the women surveyed and the frequency of consumption of individual foods (FFQ).
RESULTS
More women in 2022 ate breakfast than in 2011 (77.6% vs. 63.8% < 0.001), were more likely to eat breakfast I at home (73.1% vs. 62.5%; < 0.001), were more likely to eat breakfast II (39.0% vs. 35.2%; = 0.001), were more likely to eat breakfast II at home (28.6% vs. 19.2%; = 0.002), and were more likely to eat lunch at work (16.6% vs. 3.4%; < 0.001). Women in 2022 were more likely to consume fast-food ( = 0.001), salty snacks (chips, crisps) ( < 0.001) and sweets ( < 0.001). Women in 2022 were more likely to consume whole-grain bread ( < 0.001), wholemeal pasta ( < 0.001), brown rice ( < 0.001), oatmeal ( < 0.001), buckwheat groats ( = 0.06), and bran ( < 0.001) than women in 2011. They were less likely to consume white bread ( < 0.0001), light pasta ( = 0.004), white rice ( = 0.008) and cornflakes ( < 0.001) in 2022.Women in 2022 were significantly more likely to consume vegetables ( < 0.001) than women in 2011.
CONCLUSION
Eating habits in Silesia region women changed between 2011 and 2022. In 2022, women were more likely to choose cereal products considered health-promoting and rich in dietary fiber (including whole-grain bread, whole-grain pasta, oatmeal, bran) were more likely to consume vegetables, dry pulses and vegetarian dinners, and consumed less meat, cured meats, fish and dairy products. Consumption of fast-food, salty snacks (such as chips) and sweets increased.
PubMed: 37441516
DOI: 10.3389/fnut.2023.1219704 -
European Journal of Sport Science Oct 2023Low-carbohydrate (LC) diets are popular among general and athletic populations attempting to lose body mass. This study investigated the effect of a 7-day LC or... (Randomized Controlled Trial)
Randomized Controlled Trial
Low-carbohydrate (LC) diets are popular among general and athletic populations attempting to lose body mass. This study investigated the effect of a 7-day LC or moderate-carbohydrate (MC) calorie-restricted diet followed by 18-h recovery on body composition and taekwondo-specific performance. In this randomised cross-over study, 12 male taekwondo athletes consumed an LC (10% of carbohydrate, 41% of protein, 49% of fat, and 15.8 ± 0.4 kcal/kg/day) or an isocaloric MC diet (60% of carbohydrate, 30% of protein, and 10% of fat) for 7 days. The participants then consumed a carbohydrate-rich recovery dinner (39.2 ± 3.1 kcal/kg) followed by breakfast (6.2 ± 0.4 kcal/kg) in both the trials. Three repeated sprint ability (RSA) tests were conducted after breakfast. The taekwondo-specific reaction battery was administered before the first RSA test and after each RSA test. The participants experienced similar magnitudes of significant loss of body mass in the LC (-2.4 ± 1.7%) and MC (-2.3 ± 1.7%) trials. Fat mass and fat percentage significantly decreased in the MC trial but remained unchanged in the LC trial after body mass loss. Fat free mass was maintained in both the trials. The average and peak power in the RSA tests and the premotor reaction time were similar between the trials. The participants experienced significantly higher fatigue in the LC trial. In conclusion, both the diets can help athletes rapidly lose body mass while maintaining performance as long as an adequate amount of carbohydrate is consumed during the recovery period.
Topics: Humans; Male; Cross-Over Studies; Diet, Carbohydrate-Restricted; Body Composition; Dietary Carbohydrates; Meals
PubMed: 37010257
DOI: 10.1080/17461391.2023.2199423 -
Sensors (Basel, Switzerland) Aug 2023Continuous glucose monitoring (CGM) is used clinically and for research purposes to capture glycaemic profiles. The accuracy of CGM among healthy populations has not...
Continuous glucose monitoring (CGM) is used clinically and for research purposes to capture glycaemic profiles. The accuracy of CGM among healthy populations has not been widely assessed. This study assessed agreement between glucose concentrations obtained from venous plasma and from CGM (FreeStyle Libre2, Abbott Diabetes Care, Witney, UK) in healthy women. Glucose concentrations were assessed after fasting and every 15 min after a standardized breakfast over a 4-h lab period. Accuracy of CGM was determined by Bland-Altman plot, 15/15% sensor agreement analysis, Clarke error grid analysis (EGA) and mean absolute relative difference (MARD). In all, 429 valid CGM readings with paired venous plasma glucose (VPG) values were obtained from 29 healthy women. Mean CGM readings were 1.14 mmol/L (95% CI: 0.97 to 1.30 mmol/L, < 0.001) higher than VPG concentrations. Ratio 95% limits of agreement were from 0.68 to 2.20, and a proportional bias (slope: 0.22) was reported. Additionally, 45% of the CGM readings were within ±0.83 mmol/L (±15 mg/dL) or ±15% of VPG, while 85.3% were within EGA Zones A + B (clinically acceptable). MARD was 27.5% (95% CI: 20.8, 34.2%), with higher MARD values in the hypoglycaemia range and when VPG concentrations were falling. The FreeStyle Libre2 CGM system tends to overestimate glucose concentrations compared to venous plasma samples in healthy women, especially during hypoglycaemia and during glycaemic swings.
Topics: Humans; Female; Glucose; Blood Glucose; Blood Glucose Self-Monitoring; Hematologic Tests; Hypoglycemia
PubMed: 37687871
DOI: 10.3390/s23177417 -
Nutrients Oct 2023Dietary habits, including meal frequency, meal timing, and skipping meals, have been extensively studied due to their association with the development of noncommunicable...
Dietary habits, including meal frequency, meal timing, and skipping meals, have been extensively studied due to their association with the development of noncommunicable diseases (NCDs). This study describes dietary habits, meal timing, frequency, skipping meals, and late-night eating in Kuwaiti adults. Kuwait National Nutrition Surveillance System data were utilized to reach the objectives of this study. The findings reveal that approximately 54% of the adults in Kuwait eat after 10 p.m., 29% skip breakfast, and 9.8% skip dinner. Furthermore, adults in Kuwait consume 4.4 meals per day on average. Women skip breakfast more often and have more extended night fasting than men ( < 0.001). Married adults skip breakfast and dinner less than unmarried adults ( < 0.001). In conclusion, this descriptive study provides valuable insights into the dietary habits of Kuwaiti adults, emphasizing the importance of further investigating the association between meal timing, meal frequency, and the prevalence of NCDs in Kuwait.
Topics: Male; Humans; Adult; Female; Kuwait; Meals; Feeding Behavior; Breakfast; Fasting
PubMed: 37960190
DOI: 10.3390/nu15214537 -
CNS Drugs Dec 2023The transient receptor potential canonical (TRPC) ion channels have been implicated in the pathophysiology of major depressive disorder (MDD), and TRPC inhibition has... (Randomized Controlled Trial)
Randomized Controlled Trial
Effects of Single and Multiple Ascending Doses of BI 1358894 in Healthy Male Volunteers on Safety, Tolerability and Pharmacokinetics: Two Phase I Partially Randomised Studies.
INTRODUCTION
The transient receptor potential canonical (TRPC) ion channels have been implicated in the pathophysiology of major depressive disorder (MDD), and TRPC inhibition has been shown to reduce depressive-like behaviour in rodent models of depression. BI 1358894, a small-molecule inhibitor of TRPC ion channels, is currently being developed for the treatment of MDD.
OBJECTIVE
Two phase I studies assessed the safety, tolerability, and pharmacokinetics (PK) of oral BI 1358894 in fed and fasted states following a single ascending dose (SAD) [NCT03210272/1402-0001] and multiple ascending doses (MAD) [NCT03754959/1402-0002] in healthy male volunteers. In addition, any potential food effect was evaluated after a single dose.
METHODS
In both studies, eligible healthy male volunteers (aged 18-45 years; body mass index of 18.5-29.9 kg/m) were allocated to receive BI 1358894 or placebo. In the SAD study (1402-0001), volunteers were randomised 3:1 to receive BI 1358894 or placebo in fasted (3, 6, 10, 25, 50, 100, or 200 mg) and fed states (200 mg). The food effect part was conducted as an open-label, randomised, two-way crossover study at doses of 50 and 100 mg in fasted and fed states (high-calorie, high-fat breakfast). For the MAD study (1402-0002), volunteers were randomised 4:1 to receive BI 1358894 (10, 25, 50, 100, or 200 mg) or placebo once daily for 14 days under fed conditions. Primary endpoint (both studies): number of volunteers with drug-related adverse events (DRAEs). Secondary PK endpoints for study 1402-0001: area under the concentration-time curve (AUC) from time zero extrapolated to infinity (AUC), maximum plasma concentration (C), and AUC from time zero to the last quantifiable data time point (AUC). Secondary PK endpoints for study 1402-0002: AUC over 0-24 h (AUC), C after the first dose, and steady-state AUC and C over a uniform dosing interval (AUC and C, respectively) after the last dose.
RESULTS
BI 1358894 was well tolerated at doses ≤ 200 mg under all tested conditions and no dose dependency was observed in DRAE frequency for either study. In the SAD study, BI 1358894 exposure increased dose proportionally across 3-50 mg in the fasted state and across 50-200 mg in the fed state. A positive food effect was observed at the tested doses. In the MAD study, BI 1358894 exposure increased less than dose proportionally across 10-200 mg.
CONCLUSIONS
These studies demonstrate that BI 1358894 is well tolerated in healthy male volunteers following single and multiple doses, with no dose dependency observed in DRAE frequency. BI 1358894 exposure increased dose dependently in both the SAD and MAD studies, with higher exposure of BI 1358894 observed in the fed state.
CLINICALTRIALS REGISTRATION
These trials have been registered on ClinicalTrials.gov: NCT03210272/1402-0001 (registered on 6 July 2017) and NCT03754959/1402-0002 (registered on 27 November 2018).
Topics: Humans; Male; Administration, Oral; Area Under Curve; Cross-Over Studies; Depressive Disorder, Major; Dose-Response Relationship, Drug; Double-Blind Method; Healthy Volunteers; Ion Channels
PubMed: 38019355
DOI: 10.1007/s40263-023-01041-4 -
European Journal of Pharmaceutics and... Jul 2024Mathematical models that treat the fed stomach content as a uniform entity emptied with a constant rate may not suffice to explain pharmacokinetic profiles recorded in... (Randomized Controlled Trial)
Randomized Controlled Trial
Drug dissolution and transit in a heterogenous gastric chyme after fed administration: Semi-mechanistic modeling and simulations for an immediate-release and orodispersible tablets containing a poorly soluble drug.
Mathematical models that treat the fed stomach content as a uniform entity emptied with a constant rate may not suffice to explain pharmacokinetic profiles recorded in clinical trials. In reality, phenomena such as the Magenstrasse or chyme areas of different pH and viscosity, play an important role in the intragastric drug dissolution and its transfer to the intestine. In this study, we investigated the data gathered in the bioequivalence trial between an immediate-release tablet (Reference) and an orally dispersible tablet (Test) with a poorly soluble weak base drug administered with or without water after a high-fat high-calorie breakfast. Maximum concentrations (C) were significantly greater after administering the Reference product than the Test tablets, despite similar in vitro dissolution profiles. To explain this difference, we constructed a novel semi-mechanistic IVIVP model including a heterogeneous gastric chyme. The drug dissolution in vivo was modeled from the in vitro experiments in biorelevant media simulating gastric and intestinal fluids in the fed state (FEDGAS and FeSSIF). The key novelty of the model was separating the stomach contents into two compartments: isolated chyme (the viscous food content) that carries the drug slowly, and aq_chyme open for rapid Magenstrasse-like routes of drug transit. Drug distribution between these two compartments was both formulation- and administration-dependent, and recognized the respective drug fractions from the clinical pharmacokinetic data. The model's assumption about the nonuniform mixing of the API with the chyme, influencing differential drug dissolution and transit kinetics, led to simulating plasma concentration profiles that reflected well the variability observed in the clinical trial. The model indicated that, after administration, the Reference product mixes to a greater extent with aq_chyme, where the released drug dissolves better and transfers faster to the intestine. In conclusion, this novel approach underlines that diverse gastric emptying of different oral dosage forms may significantly impact pharmacokinetics and affect the outcomes of bioequivalence trials.
Topics: Humans; Tablets; Drug Liberation; Solubility; Administration, Oral; Therapeutic Equivalency; Gastric Emptying; Models, Biological; Male; Adult; Gastrointestinal Transit; Gastrointestinal Contents; Viscosity; Hydrogen-Ion Concentration; Stomach; Computer Simulation; Young Adult; Gastric Mucosa; Cross-Over Studies
PubMed: 38795785
DOI: 10.1016/j.ejpb.2024.114341 -
Nutrients Apr 2024Evidence suggests that tart cherry (TC) supplementation has beneficial effects on health indices and recovery following strenuous exercise. However, little is known... (Randomized Controlled Trial)
Randomized Controlled Trial
Evidence suggests that tart cherry (TC) supplementation has beneficial effects on health indices and recovery following strenuous exercise. However, little is known about the mechanisms and how TC might modulate the human metabolome. The aim of this study was to evaluate the influence of an acute high- and low-dose of Vistula TC supplementation on the metabolomic profile in humans. In a randomised, double-blind, placebo controlled, cross-over design, 12 healthy participants (nine male and three female; mean ± SD age, stature, and mass were 29 ± 7 years old, 1.75 ± 0.1 m, and 77.3 ± 10.5 kg, respectively) visited the laboratory on three separate occasions (high dose; HI, low dose; LO, or placebo), separated by at least seven days. After an overnight fast, a baseline venous blood sample was taken, followed by consumption of a standardised breakfast and dose conditions (HI, LO, or placebo). Subsequent blood draws were taken 1, 2, 3, 5, and 8 h post consumption. Following sample preparation, an untargeted metabolomics approach was adopted, and the extracts analysed by LCMS/MS. When all time points were collated, a principal component analysis showed a significant difference between the conditions ( < 0.05), such that the placebo trial had homogeneity, and HI showed greater heterogeneity. In a sub-group analysis, cyanidine-3--glucoside (C3G), cyanidine-3--rutinoside (C3R), and vanillic acid (VA) were detected in plasma and showed significant differences ( < 0.05) following acute consumption of Vistula TC, compared to the placebo group. These results provide evidence that phenolics are bioavailable in plasma and induce shifts in the metabolome following acute Vistula TC consumption. These data could be used to inform future intervention studies where changes in physiological outcomes could be influenced by metabolomic shifts following acute supplementation.
Topics: Humans; Female; Male; Young Adult; Adult; Prunus avium; Metabolome; Metabolomics; Body Height; Breakfast
PubMed: 38613057
DOI: 10.3390/nu16071023 -
Nutrients Jul 2023The increasing prevalence of prediabetes globally does not bode well for the growing epidemic of type 2 diabetes (T2D) and its complications. Yet there is a lack of...
The increasing prevalence of prediabetes globally does not bode well for the growing epidemic of type 2 diabetes (T2D) and its complications. Yet there is a lack of studies regarding lifestyle patterns (LPs) and their association with prediabetes. The present study aimed to examine the association of different LPs with the existence of prediabetes in adults from families at high risk for T2D in Europe. In total, 2759 adults (66.3% females) from six European countries were included in this cross-sectional analysis using data from the baseline assessment of the Feel4Diabetes study. Anthropometric, sociodemographic, dietary and behavioral data were assessed, and fasting blood glucose measurements were also obtained. LPs were derived via principal component analysis. Two LPs were derived, explaining 32% of the total variation. LP 1 was characterized by breakfast consumption, high consumption of fruits and berries, vegetables and nuts and seeds, and low consumption of salty snacks and soft drinks with sugar, while LP 2 was characterized by high consumption of salty and sweet snacks, soft drinks with sugar and juice with sugar and sedentary behavior. After adjusting for various confounders, LP 2 was positively associated with the existence of prediabetes (odds ratio = 1.02, 95% CI 1.01-1.04), while LP 1 was not significantly associated with prediabetes. Understanding LPs would provide necessary evidence for planning intervention and education strategies for prediabetes and T2D.
Topics: Female; Humans; Adult; Male; Diabetes Mellitus, Type 2; Prediabetic State; Cross-Sectional Studies; Lipopolysaccharides; Europe; Life Style; Sugars
PubMed: 37513573
DOI: 10.3390/nu15143155