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The American Journal of Clinical... May 2024The longitudinal association between specific eating behaviors, such as skipping breakfast and night eating, and changes in weight and waist circumference (WC) has been...
BACKGROUND
The longitudinal association between specific eating behaviors, such as skipping breakfast and night eating, and changes in weight and waist circumference (WC) has been understudied.
OBJECTIVES
The objective of this study was to investigate whether skipping breakfast and night eating were individually or jointly associated with the annual changes in weight and WC.
METHODS
In the current longitudinal study, included were 48,150 Chinese adults (mean age: 50.1 ± 13.9 y) who were free of diabetes, cardiovascular diseases, and cancer in 2014, when data on dietary intake and the presence of night-eating behavior and skipping breakfast were collected via questionnaires. Weight and WC were measured repeatedly in 2014, 2016, and 2018. The associations between night eating and/or skipping breakfast and annual changes in weight and WC were evaluated using the generalized estimating equation models, adjusting for age, sex, total energy, diet quality, and other potential confounders.
RESULTS
During 4-y of follow-up, among people who had both 2 unhealthy eating behaviors, the mean difference in annual weight change was 0.53 kg (95% confidence interval: 0.43, 0.63 kg) and 0.41 cm (95% confidence interval: 0.27, 0.55 cm) in annual WC change, compared with participants without either behavior. The associations of eating behaviors and change in weight and WC were more pronounced in participants with higher baseline body mass index (in kg/m) relative to their counterparts. Similarly, the associations between these eating behaviors and WC change were stronger in those with poorer diet quality relative to those with better diet quality.
CONCLUSIONS
Individuals with frequent skipping breakfast and/or night eating experienced faster gains in weight and WC, even after adjusting for diet quality and energy intake.
PubMed: 38802062
DOI: 10.1016/j.ajcnut.2024.05.021 -
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 May 2024In Japan, many workers are exposed to chronic stress, sleep deprivation, and nutritional imbalance. They tend still to go to work when ill, leading to decreased work...
In Japan, many workers are exposed to chronic stress, sleep deprivation, and nutritional imbalance. They tend still to go to work when ill, leading to decreased work performance and productivity, which has become a major social problem. We conducted a human entry study with the aim of finding a link between these two factors and proposing an optimized diet, believing that a review of diet may lead to an improvement in labor productivity. In this study, we used subjective accomplishment (SA) as a measure of productivity. First, we compared nutrient intake between groups with high and low SA using data from a health survey of 1564 healthy male and female adults. Significant differences were found in the intake of 13 nutrients in males and 15 nutrients in females, including potassium, vitamin A, insoluble fiber, and biotin. Recommended daily intake of these nutrients was determined from survey data. Next, we designed test meals containing sufficient amounts of 17 nutrients and conducted a single-arm intervention study (registration code UMIN000047054) in Kameyama City, Mie Prefecture, Japan. Healthy working adults (males and females aged 20-79 years) were recruited and supplied with test meals, which were eaten once a day 5 days a week for 8 weeks. SA was significantly higher and daytime sleepiness (DS) was significantly lower after lunch on workdays in younger participants (under 60 years) when they ate the test meals as breakfast or lunch. Our results suggest that SA and DS, which change daily, are strongly influenced by the meal eaten before work, and that taking the 17 nutrients may help prevent presenteeism and improve labor productivity.
Topics: Humans; Male; Female; Adult; Middle Aged; Japan; Aged; Nutrients; Young Adult; Health Surveys; Efficiency; Diet; Work Performance; Meals
PubMed: 38794648
DOI: 10.3390/nu16101410 -
Stroke and Vascular Neurology Jun 2024The incidence of vascular cognitive impairment (VCI) is high in patients suffering from ischaemic stroke or transient ischaemic attack (TIA) or with vascular risk...
Efficacy and safety of Ferrous iron on the prevention of Vascular cOgnitive impaiRment among patients with cerebral Infarction/TIA (FAVORITE): rationale and design of a multicentre randomised trial.
BACKGROUND
The incidence of vascular cognitive impairment (VCI) is high in patients suffering from ischaemic stroke or transient ischaemic attack (TIA) or with vascular risk factors. Effective prevention strategies for VCI remain limited. Anaemia or low haemoglobin was found as an independent risk factor for adverse outcomes after acute stroke. Anaemia or low haemoglobin was possibly associated with an increased risk of poststroke cognitive impairment. Whether supplement of ferrous iron to correct anaemia reduces the risk of VCI and improves adverse outcomes in patients with ischaemic cerebrovascular disease remains uncertain.
AIM
We aim to introduce the design and rationale of the safety and efficacy of Ferrous iron on the prevention of Vascular cOgnitive impaiRment in patients with cerebral Infarction or TIA (FAVORITE) trial.
DESIGN
FAVORITE is a randomised, placebo-controlled, double-blind, multicentre trial that compares supplement of ferrous iron with placebo for recent minor stroke/TIA patients complicated with mild anaemia or iron deficiency: Ferrous succinate sustained-release tablet 0.2 g (corresponding to 70 mg of elemental iron) once daily after or during breakfast for 12 weeks or placebo with much the same colour, smell and size as ferrous iron once daily during or after breakfast for 12 weeks. All paticipants will be followed within the next year.
STUDY OUTCOMES
The primary effective outcome is the incidence of VCI at 3 months after randomisation and the primary safety outcome includes any gastrointestinal adverse event during 3 months.
DISCUSSION
The FAVORITE trial will clarify whether supplement of ferrous iron to correct low haemoglobin reduces the risk of VCI in patients with recent ischaemic stroke or TIA complicated with mild anaemia or iron deficiency compared with placebo.
TRIAL REGISTRATION NUMBER
NCT03891277.
PubMed: 38789134
DOI: 10.1136/svn-2023-002644 -
Clinical Therapeutics May 2024Venetoclax is a potent, orally bioavailable BCL-2 inhibitor used in the treatment of some hematological malignancies. Crushing tablets may be necessary to help with the...
PURPOSE
Venetoclax is a potent, orally bioavailable BCL-2 inhibitor used in the treatment of some hematological malignancies. Crushing tablets may be necessary to help with the administration of venetoclax to patients with swallowing difficulties or patients requiring nasogastric tube feeding. The study was conducted to assess the bioavailability of crushed and finely ground venetoclax tablets relative to whole tablets.
METHODS
An open-label, randomized, 3-way, crossover study in 15 healthy adult females was conducted. Venetoclax tablets were administered orally in a crushed, ground or intact form on Day 1 of each period with water following a high-fat breakfast. Pharmacokinetic samples were collected up to 72 hours postdosing.
FINDINGS
The crushed and ground tablets met the bioequivalence criteria (0.80-1.25) relative to the intact tablets with respect to area under the concentration-time curve to time of the last measurable concentration (AUC) and to infinite time (AUC) but exhibited a slightly lower maximum plasma concentration (C). This was not considered clinically significant as only venetoclax overall exposure (AUC) has been shown to correlate with clinical efficacy. There was no change in the physical appearance and the evaluated physicochemical properties of crushed and ground venetoclax tablets after 72 hours of storage at 25°C/60% relative humidity.
IMPLICATIONS
Crushing or grinding venetoclax tablets before administration could be considered as a viable alternative method of administration for patients who have difficulty swallowing whole venetoclax tablets or patients requiring nasogastric tube feeding.
GOV IDENTIFIERS
NCT05909553, registered June 12, 2023.
PubMed: 38782609
DOI: 10.1016/j.clinthera.2024.03.012 -
Applied Physiology, Nutrition, and... May 2024Limited research has characterized the metabolic health benefits of bodyweight interval exercise (BWE) performed outside of a laboratory setting. Metabolic responses to...
Limited research has characterized the metabolic health benefits of bodyweight interval exercise (BWE) performed outside of a laboratory setting. Metabolic responses to exercise can also be influenced by meal timing around exercise, but the interactive effects of BWE and nutrition are unknown. This study investigated the effects of BWE performed in the fasted or fed state on postprandial glycemia, post-exercise fat oxidation and appetite perceptions. 12 females (23±2yr; 22±2kg/m2) underwent two virtually-monitored trials which involved completing BWE (10x1-min, 1-min recovery) 5 min before (FastEX) or beginning BWE 10 min after (FedEX) a standardized breakfast. Heart rate and rating of perceived exertion (RPE) were measured during exercise and capillary glucose concentrations were measured for 2 hr postprandial. Following exercise, appetite perceptions were assessed and Lumen expired carbon dioxide percentage (L%CO2) was measured as an index of fat oxidation. Heart rate (85±5%) and RPE (14±2) did not differ between conditions (p>0.05). Postprandial glucose mean (6.1±0.6 vs. 6.8±0.8 mmol/L, p=0.03), peak (7.4±1.2 vs. 8.5±1.5 mmol/L, p=0.01) and area under the curve (AUC) (758±72 vs. 973±82 mmol/L x 2 hr, p=0.004) were lower in FedEX vs. FastEX. Appetite perceptions were lower in FedEX vs. FastEX (-87.63±58.51 vs. -42.06 ± 34.96 mm, p=0.029). Post-exercise L%CO2 was transiently decreased 30 min post-exercise in both conditions (4.03 ± 0.38 vs. 4.29 ± 0.34%, p=0.0023), reflective of increased fat oxidation following BWE. These findings demonstrate that BWE performed in the fed compared to the fasted state lowered postprandial glycemia and appetite perceptions in females. ClinicalTrials.gov (NCT06240442).
PubMed: 38776559
DOI: 10.1139/apnm-2023-0485 -
Frontiers in Endocrinology 2024To evaluate the efficacy and safety of URLi (ultra rapid lispro insulin) compared to insulin lispro as bolus insulin with basal insulin using CGM in the individuals with... (Randomized Controlled Trial)
Randomized Controlled Trial
AIM
To evaluate the efficacy and safety of URLi (ultra rapid lispro insulin) compared to insulin lispro as bolus insulin with basal insulin using CGM in the individuals with type 2 diabetes(T2D) in China.
METHODS
This was a double-blind, randomized, parallel, prospective, phase 3 study. Subjects with uncontrolled T2D were recruited and randomized 1:2 into the insulin lispro and URLi groups. Subjects received a consistent basal insulin regimen during the study and self-administered insulin lispro or URLi before each meal throughout the treatment period. Subjects underwent a 3-day continuous glucose monitoring (CGM) at the baseline and endpoint respectively, and then CGM data were analyzed. The primary endpoint was to compare the difference in postprandial glucose (PPG) control using CGM between the two groups.
RESULTS
A total of 57 subjects with T2D completed the study. Our CGM data showed that postprandial glucose excursions after breakfast (BPPGE) in the URLi group was lower than that in the insulin lispro group (1.59 ± 1.57 mmol/L vs 2.51 ± 1.73 mmol/L, p = 0.046). 1-hour PPG was observed to decrease more in the URLi group than that in the insulin lispro group (-1.37 ± 3.28 mmol/L vs 0.24 ± 2.58 mmol/L, p = 0.047). 2-hour PPG was observed to decrease more in the URLi group than that in the insulin lispro group (-1.12 ± 4.00 mmol/L vs 1.22 ± 2.90 mmol/L, p = 0.021). The mean HbA1c level decreased by 1.1% in the URLi group and 0.99% in the insulin lispro group, with no treatment difference (p = 0.642). In the CGM profile, TBR was not significantly different between the two groups (p = 0.743). The weight gain also did not differ between the two groups (p = 0.303).
CONCLUSION
URLi can control breakfast PPG better than insulin lispro in adults with T2D in China, while it is non-inferior in improving HbA1c. The incidence of hypoglycemic and weight gain were similar between the two groups.
Topics: Humans; Diabetes Mellitus, Type 2; Insulin Lispro; Male; Female; Middle Aged; Postprandial Period; Blood Glucose; China; Double-Blind Method; Hypoglycemic Agents; Blood Glucose Self-Monitoring; Prospective Studies; Glycemic Control; Adult; Aged; Glycated Hemoglobin; Drug Therapy, Combination
PubMed: 38774225
DOI: 10.3389/fendo.2024.1364585 -
The Journal of Nutrition May 2024□ OBJECTIVES: This study aimed to investigate the association between consumption of ultraprocessed foods and leucocyte telomere length (LTL).
BACKGROUND
□ OBJECTIVES: This study aimed to investigate the association between consumption of ultraprocessed foods and leucocyte telomere length (LTL).
METHODS
This cross-sectional study utilized data from the UK Biobank, including a total of 64,690 participants. LTL was measured using qPCR with natural logarithmic conversion and z-score normalization. Dietary data were collected through a 24-h recall questionnaire from 2009 to 2010. Ultraprocessed foods (UPFs) were identified using the NOVA food classification as either a continuous or a categorical variable. Multiple linear regression models were employed to analyze the association between UPF consumption and LTL.
RESULTS
The included participants had an average age of 56.26 y, of whom 55.2% were female. After adjusting for demographic and health-related variables, LTL exhibited a decrease of 0.005 (95% CI: -0.007, -0.002) with 1 UPF serving increase. Compared with participants consuming ≤3.5 servings/d, those consuming 3.5 to <6 servings showed a shortening of LTL by 0.025 (95% CI: -0.046, -0.003). Participants consuming 6 to ≤8 servings/d and >8 servings/d had LTL shortening of 0.032 (95% CI: -0.054, -0.011) and 0.037 (95% CI: -0.060, -0.014), respectively (P for trend = 0.002). Subgroup analyses by UPF subclasses revealed that the consumption of ready-to-eat/heated food (β: -0.010; 95% CI: -0.016, -0.004), beans and potatoes (β: -0.027; 95% CI: -0.043, -0.012), animal-based products (β: -0.012; 95% CI: -0.020, -0.005), artificial sugar (β: -0.014; 95% CI:-0.025,-0.003), and beverages (β: -0.005; 95% CI: -0.009, -0.001) showed negative associations with LTL. Conversely, breakfast cereals (β: 0.022; 95% CI: 0.006, 0.038) and vegetarian alternatives (β: 0.056; 95% CI:0.026,0.085) showed positive correlations with LTL.
CONCLUSIONS
Our study found that a higher consumption of total UPF was associated with a shorter LTL. However, some UPFs may be associated with longer LTL, depending on their nutritional composition.
PubMed: 38735573
DOI: 10.1016/j.tjnut.2024.05.001 -
European Journal of Nutrition May 2024In adults, diets rich in protein seem beneficial in relation to satiety, weight loss, and weight management; however, studies investigating dietary protein and weight...
Effect of a higher protein diet and lifestyle camp intervention on childhood obesity (The COPE study): results from a nonrandomized controlled trail with 52-weeks follow-up.
PURPOSE
In adults, diets rich in protein seem beneficial in relation to satiety, weight loss, and weight management; however, studies investigating dietary protein and weight development in children are scarce and inconsistent. This nonrandomized controlled trial aimed to investigate the effect of a higher protein diet during lifestyle intervention on anthropometry and metabolic biomarkers in children with overweight and obesity.
METHODS
Children (n:208) were recruited from two multicomponent lifestyle camps. One camp was assigned as the intervention group. In the intervention group, carbohydrates-rich foods at breakfast and two in-between-meals were replaced with protein-containing foods to increase the amount of protein from ~ 10-15 energy percent (E%) per day to ~ 25E% per day. Other components were similar between groups. Anthropometry and biochemical measurements were collected at baseline, 10 weeks (after camp) and 52 weeks.
RESULTS
The intervention group had a non-significant improvement in BMI-SDS (- 0.07 SD (- 0.19; 0.05), p = 0.24) compared to the control group, but in general, there was no effect of a higher protein diet on anthropometry and metabolic biomarkers. Overall, 10 weeks at camp resulted in a more favorable body composition [- 6.50 kg (p < 0.00), - 0.58 BMI-SDS (p < 0.00), and - 5.92% body fat (p < 0.00)], and improved metabolic health, with most changes maintained at 52 weeks.
CONCLUSION
A higher protein diet had no significant effect on body composition and metabolic health; however, these lifestyle camps are an efficiatious treatment strategy for childhood obesity.
CLINICAL TRIAL REGISTRATION
clinicaltrials.gov with ID: NCT04522921. Preregistered August 21st 2020.
PubMed: 38724826
DOI: 10.1007/s00394-024-03420-z -
Journal of Urban Health : Bulletin of... May 2024Most restaurants serve customers excess calories which significantly contributes to the obesity epidemic. This pilot study tested the feasibility and acceptability of...
Most restaurants serve customers excess calories which significantly contributes to the obesity epidemic. This pilot study tested the feasibility and acceptability of offering customers standardized portions to reduce caloric consumption when dining out in three restaurants. Portions were developed to limit quantity of food served, with lunches and dinners ≤ 700 cal and breakfast ≤ 500 cal. Participating restaurants developed an alternative "Balanced Portions Menu." Training and instructions were provided with respect to the volume and weight of food to be plated following the standardized guidelines and providing at least one cup of vegetables per lunch/dinner. We invited local residents to help us evaluate the new menu. We monitored restaurant adherence to guidelines, obtained feedback from customers, and incentivized customers to complete dietary recalls to determine how the new menus might have impacted their daily caloric consumption. Of the three participating restaurants, all had a positive experience after creating the new menus and received more foot traffic. One restaurant that did not want to change portion sizes simply plated the appropriate amount and packed up the rest to-go, marketing the meals as "Dinner today, lunch tomorrow." Two of the restaurants followed the guidelines precisely, while one sometimes plated more rice than the three-fourths cup that was recommended. A significant number of customers ordered from the Balanced Portions menus. Two of the three restaurants have decided to keep offering the Balanced Portions menus indefinitely. Following standardized portions guidelines is both feasible for restaurants and acceptable to customers.
PubMed: 38720143
DOI: 10.1007/s11524-024-00867-7