Is freeze-dried superfood kale supplementation healthier than common green peas? Outcomes of a cross-over trial.

Kale (Brassica oleracea species) is considered a functional food whose macronutrient and phytochemical contents are considered beneficial and widely considered as a superfood. In the present 6-week cross-over trial with a 2-week washout period, we compared the beneficial effects of freeze-dried kale over peas among Arab women with obesity. A total of 124 Saudi women with obesity were allocated to receive either freeze-dried kale (n = 62) or freeze-dried peas (n = 62) given in the form of 3-gram sachets thrice daily for 2 weeks, followed by a 2-week washout period and a cross-over of 4 weeks. Anthropometric measurements, glucose, lipids and markers of gut barrier function were assessed at baseline and post-intervention. Participants who took kale supplementation first resulted in significant weight reduction (p = 0.02) which was not observed among those who took peas first. Participants receiving pea supplementation first experienced a significant decline in Hba1c (p = 0.005) and CD14 (p = 0.03), but C-peptide increased (p = 0.05). Crossover analysis revealed significant carryover effects in most variables with non-significant combined treatment effects. Among the variables with no carryover effect with significant combined treatment effect include HbA1c which was in favor of the pea group (p = 0.005) and C-peptide which was modestly in favor of the kale group (p = 0.05). While both freeze dried kale and pea supplementation appear beneficial, supplementation of freeze-dried pea appears to be more effective in terms of acute glycemic control than kale. The study suggests that common but less-hyped vegetables such as pea maybe equally, if not more beneficial than the more expensive promoted superfoods such as kale. Longer clinical trials using a parallel design instead of cross-over are recommended to strengthen present findings.

The effect of Mankai plant consumption on postprandial glycaemic response among patients with type 2 diabetes: A randomized crossover trial.

AIM: To explore the effect of Mankai, a cultivated aquatic duckweed green plant, on postprandial glucose (PG) excursions in type 2 diabetes (T2D). METHODS: In a 4-week, randomized crossover-controlled trial, we enrolled 45 adults with T2D (HbA1c range: 6.5%-8.5%) from two sites in Israel. Participants were randomized to drink Mankai (200 mL of raw-fresh-aquatic plant + 100 mL of water, 40 kcal, ~10 g of dry matter equivalent) or water (300 mL) following dinner, for 2 weeks each, with a 4-day washout interval, without dietary, physical activity or pharmacotherapy alterations. We used continuous glucose monitoring (CGM) devices. RESULTS: Forty patients (adherence rate = 88.5%; 743 person-intervention-days, 68.9% men, age = 64 years, HbA1c = 6.8%) completed the study with a consistent diet and complete CGM reads. Only two-thirds of the individuals responded beneficially to Mankai. Overall, Mankai significantly lowered the PG peak by 19.3% (∆peak = 24.3 ± 16.8 vs. 30.1 ± 18.5 mg/dL; P < .001) and delayed the time-to-peak by 20.0% (112.5 [interquartile range: 75-135] vs. 90 [60-105] min; P < .001) compared with water. The PG incline and decline slopes were shallower following postdinner Mankai (incline slope: 16.8 vs. water: 29.9 mg/[dL h]; P < .001; decline slope: -6.1 vs. water: -7.9 mg/[dL h]; P < .01). Mean postprandial net incremental area-under-the-glucose-curve was lowered by 20.1% with Mankai compared with water (P = .03). Results were consistent across several sensitivity and subgroup analyses, including across antidiabetic pharmacotherapy treatment groups. Within 2 weeks, the triglycerides/high-density lipoprotein cholesterol ratio in the Mankai group (-0.5 ± 1.3) decreased versus water (+0.3 ± 1.5, P = .05). CONCLUSIONS: Mankai consumption may mitigate the PG response in people with T2D with an ~20% improvement in glycaemic values. These findings provide case-study evidence for plant-based treatments in T2D to complement a healthy lifestyle and pharmacotherapy.

A randomized crossover trial of regional anticoagulation modalities for intermittent hemodialysis.

INTRODUCTION: The optimal regional anticoagulation (RA) of dialysis filters in patients at risk of bleeding remains elusive. Inducing hypocalcemia within the filter by using a calcium-free dialysate has emerged as an easy-to-use heparin-free RA, including in critically ill patients, but comparative studies are lacking. METHODS: We conducted a multicentre, randomized, crossover trial to compare the efficacy and tolerance of two RAs (heparin-coated membrane (HCM) or calcium free dialysate with calcium reinjection according to ionic dialysance (CFD)) in patients requiring hemodialysis and at risk of bleeding. During the study period, each patient received two dialysis sessions (one with each RA in a randomly assigned order). The primary endpoint was the proportion of dialysis sessions completed (≥ 240 min). RESULTS: 94 patients were included in the intention-to-treat analysis, including 16 critically ill patients (17.0%). Coagulation and inflammation parameters, as well as hemodynamic status at baseline, were balanced between groups. Premature coagulation of the filter occurred in 19 HCM (20.9%) compared to 3 (3.2%) CFD sessions. In half of the sessions with premature termination, coagulation occurred before 180 minutes. The proportion of patients who completed the CFD session while failing to complete the HCM session (n = 17) was significantly higher than the proportion of patients who completed the HCM session while failing to complete the CFD session (n = 1; p < 0.001). Hemodynamic and metabolic tolerance were not different between groups. CONCLUSIONS: In individuals at risk of bleeding, RA with calcium-free dialysate significantly reduces the incidence of premature dialysis termination compared to heparin-coated membrane without safety concerns. Trial registration and statistical analysis plan: ClinicalTrials.gov identifier: NCT03842657.

Effect of calcium supplementation on reversing metformin-based inhibition of vitamin B12 bioavailability in healthy adults using a [13C] cyanocobalamin tracer - A pilot study.

BACKGROUND & AIMS: Metformin is a widely prescribed first line drug for the treatment of type 2 diabetes mellitus (DM). Studies have shown that the use of metformin is often associated with a decrease in vitamin B12 (B12) levels in patients with DM. Few studies have shown that this effect could be mitigated with calcium supplementation. In the present study, we quantified the effect of metformin, and metformin co-administered with calcium on B12 absorption using a novel stable isotope [13C] cyanocobalamin tracer. METHODS: A pilot crossover study was conducted to estimate the bioavailability of B12 in healthy subjects, using [13C] cyanocobalamin as a tracer. In the study, [13C] cyanocobalamin was administered orally to the participants followed by hourly venous sampling to measure the concentration of the tracer and estimate bioavailability. This protocol was followed for three experiment days, each separated by a one month wash out period. As part of the study, all participants received the tracer alone for the control day (C), metformin 850 mg along with the tracer for the metformin day (M) and metformin 850 mg with calcium 500 mg and the tracer for the metformin calcium day (MC). RESULTS: Seven participants completed all three experiment days. The mean B12 bioavailability (±SD, n = 7) was 42.6 ± 10.2% for the control day (C), 30.8 ± 15.3% for the metformin day (M) and 46.4 ± 8.6% for the metformin-calcium day (MC). Repeated measures ANOVA was done and the pairwise comparison showed a significant difference in the B12 bioavailability between control and metformin day (C vs M p = 0.010), and between the metformin and metformin with calcium day (M vs MC p = 0.003). CONCLUSION: B12 bioavailability reduced significantly from baseline (C) when metformin (M) was administered and this reduction was reversed when calcium was co-administered (MC) in healthy participants. In patients using metformin, calcium supplementation as a strategy to prevent B12 deficiency needs to be further studied.

Optimal designs using generalized estimating equations in cluster randomized crossover and stepped wedge trials.

Cluster randomized crossover and stepped wedge cluster randomized trials are two types of longitudinal cluster randomized trials that leverage both the within- and between-cluster comparisons to estimate the treatment effect and are increasingly used in healthcare delivery and implementation science research. While the variance expressions of estimated treatment effect have been previously developed from the method of generalized estimating equations for analyzing cluster randomized crossover trials and stepped wedge cluster randomized trials, little guidance has been provided for optimal designs to ensure maximum efficiency. Here, an optimal design refers to the combination of optimal cluster-period size and optimal number of clusters that provide the smallest variance of the treatment effect estimator or maximum efficiency under a fixed total budget. In this work, we develop optimal designs for multiple-period cluster randomized crossover trials and stepped wedge cluster randomized trials with continuous outcomes, including both closed-cohort and repeated cross-sectional sampling schemes. Local optimal design algorithms are proposed when the correlation parameters in the working correlation structure are known. MaxiMin optimal design algorithms are proposed when the exact values are unavailable, but investigators may specify a range of correlation values. The closed-form formulae of local optimal design and MaxiMin optimal design are derived for multiple-period cluster randomized crossover trials, where the cluster-period size and number of clusters are decimal. The decimal estimates from closed-form formulae can then be used to investigate the performances of integer estimates from local optimal design and MaxiMin optimal design algorithms. One unique contribution from this work, compared to the previous optimal design research, is that we adopt constrained optimization techniques to obtain integer estimates under the MaxiMin optimal design. To assist practical implementation, we also develop four SAS macros to find local optimal designs and MaxiMin optimal designs.

The efficacy of ball blankets on insomnia in depression in outpatient clinics: A randomised crossover multicentre trial.

Many patients with depression report insomnia symptoms that profoundly affect their health and well-being. Non-pharmacological treatments of insomnia may be preferable for some patients. In this randomised crossover trial, we investigated the efficacy of the Protac Ball Blanket® on insomnia among patients with depression. Included patients (n = 45) were diagnosed with unipolar depression, and with subjective insomnia and poor sleep quality (Pittsburgh Sleep Quality Index Score > 5). Each patient slept 2 weeks with a Protac Ball Blanket® and 2 weeks with a control duvet. Randomisation defined the order of the 2-week sleep periods. Patients served as their own control in this design. The primary outcome was changes in total night-time sleep. Secondary outcomes were sleep-onset latency, number of awakenings, wake after sleep onset, daily use of pro necessitate sedatives and hypnotics, subjective sleep quality (Pittsburgh Sleep Quality Index), insomnia severity (Insomnia Severity Index), symptoms of depression (Hamilton Depression Rating Scale, Major Depression Inventory), symptoms of anxiety (Beck Anxiety Index), and patient-reported outcomes concerning interpersonal sensitivity, neurasthenia, anxiety and depression (Self-Reported Symptom State Scale). Paired two-sided t-tests were used to compare the means of the differences of the outcomes. Protac Ball Blanket® increased total night-time sleep by 12.9 min (95% confidence interval: 1.21-24.63, p = 0.031). Among the secondary outcomes, Protac Ball Blanket® decreased Hamilton Depression Rating Scale by 2.78 (95% confidence interval: -5.44; -0.11, p = 0.042) and Insomnia Severity Index by 2.98 (95% confidence interval: -5.45; -0.50, p = 0.020). No changes were observed in sleep-onset latency, number of awakenings, wake after sleep onset, Pittsburgh Sleep Quality Index, Major Depression Inventory, Beck Anxiety Index, Self-Reported Symptom State Scale, and medication use. The results suggest that some patients may benefit from Protac Ball Blanket® as an add-on non-pharmacological treatment to improve sleep in depression.

Complete denture palatal rugae design impact on satisfaction and quality of life.

OBJECTIVES: To compare the impact of three complete denture palatal rugae designs on participants' satisfaction and oral-health-related quality of life. BACKGROUND: Complete dentures palatal rugea are usually polished to a smooth finish, which can affect the patient's adaptation. Roughening or keeping an opening in the rugae area to replicate the natural sensation of the palatal rugae has been suggested but lacks clinical evidence. METHODS: This randomised crossover trial included participants with complete dentures randomly allocated to six sequences. Each sequence alternated between polished, roughened, and open rugae designs. Participants evaluated general and domain-specific satisfaction (eating, taste, speaking, phonetics, and ease of cleaning) on a 100-mm visual analogue scale. They also completed the Oral Health Impact Profile for Edentulous Patients (OHIP-EDENT) and indicated their preferred design at the end. Repeated-measure ANOVA compared satisfaction, and one-way ANOVA with Tukey's test compared OHIP-EDENT scores. RESULTS: Forty-two participants were randomised. Seven dropped out. General satisfaction ratings were comparable for the polished (Mean = 80.2, SD = 19.7) and roughened designs (Mean = 79.5, SD = 20.2). However, the open design had a significantly lower satisfaction rating (Mean = 41.1, SD = 32.2). OHIP-EDENT scores for the open design (Mean = 44.9, SD = 17.5) were significantly worse than those for the polished (Mean = 36.1, SD = 12.7) and roughened designs (Mean = 36.2, SD = 13.3). Two-thirds of the participants chose the polished design. One-third chose the roughened design; of those, 83% were first-time denture wearers. CONCLUSIONS: Complete dentures with polished and roughened rugae designs were perceived similarly. Both designs could be recommended based on the patient's preference. However, the open design should be avoided due to negative perception.

Effect of high-definition transcranial direct current stimulation among late-subacute and chronic stroke survivors with fatigue: A randomized-controlled crossover trial protocol.

Post-stroke fatigue (PSF) is a commonly overlooked symptom that impacts daily functioning and quality of life. It is caused by altered functional connectivity within the brain networks, which can potentially be influenced by neuromodulation. Multiple cortical regions have been targeted to reduce PSF, but the most efficient ones remain uncertain. Therefore, we aim to identify the most appropriate cortical stimulation site to reduce PSF. Twenty participants with PSF will be included in this cross-over trial. Each participant will receive one session of active anodal high definition- transcranial direct current stimulation (HD-tDCS) over three different cortical areas and one session of sham tDCS in a cross-over manner, with a two-week of washout period in between. Pre- and post- fatigue will be assessed using Fatigue Severity Scale and fatigability using electromyography by determining the time to task failure. Resting-state electroencephalography will be performed before and after each stimulation session to determine the functional connectivity of the cortical areas stimulated.

Electric massage chairs reduce labor pain in nulliparous patients: a randomized crossover trial.

BACKGROUND: Labor pain varies significantly among pregnant women, ranging from mild to extremely distressing. Nonpharmacologic pain relief methods during vaginal birth are increasingly popular, either as a complement to pharmacologic agents or, at times, as the primary method of pain relief. Multiple trials have reported that manual or by-hand massage reduces labor pain. The effectiveness of full-body mechanical massage using electric massage chairs on labor pain remains unexplored. OBJECTIVE: This study aimed to evaluate mechanical massage using an electric massage chair on labor pain in nulliparous women. STUDY DESIGN: A randomized counterbalanced crossover trial was conducted in a university hospital in Malaysia from August 2022 to February 2023. Eligible nulliparas in labor with a minimum labor pain score of 5 (0-10 numerical rating scale) were enrolled. Participants were randomized to 30 minutes on the massage chair with mechanical massage followed by 30 minutes on the massage chair without mechanical massage or the other way around in the massage sequence. The primary outcome was a change in pain score comparing pain with and without mechanical massage as a paired comparison for the entire trial participants. The secondary outcomes were across arms analyses of maternal and neonatal outcomes. The paired t test, t test, Mann-Whitney U test, chi-square test, and Fisher exact test were used as appropriate for the data. RESULTS: Overall, 208 women were randomized: 104 to each intervention. Data were available from 204 participants (103 randomized to massage first and 101 to no massage first). The primary outcomes of change in labor pain scores (0-10 numerical rating scale) after massage and no massage (all participants included after crossover, paired t test analysis) were 4.51±2.30 and 5.38±2.10, respectively (mean difference, -0.87; 95% confidence interval, -1.14 to -0.59; P<.001), a significant reduction in pain score after electric chair mechanical massage compared with no massage. On the across randomized arms secondary analyses, labor pain scores after their first massage chair session were 4.35±2.52 (randomized to massage first, received massage as initial intervention) and 5.66±1.73 (randomized to no massage first, received no massage as initial intervention) (mean difference, -1.31; 95% confidence interval, -1.91 to -0.748; P<.001), a significant reduction after mechanical massage. Other distal maternal outcomes (mode of delivery, labor analgesia, duration of labor, and maternal agreement that mechanical massage is effective for labor pain) and neonatal outcomes (Apgar scores at 1 and 5 minutes, cord artery blood pH and base excess, and neonatal admission) were not different across randomized arms. CONCLUSION: Mechanical massage using an electric massage chair significantly reduced labor pain, offering a potential nonpharmacologic pain management option during labor.

Adaptation of a health literacy screener for computerized, self-administered use by U.S. adults.

Objective: Health literacy is a critical health determinant, for which few computerized, self-administered assessments exist. This study adapted and tested the reliability of the Newest Vital Sign© (NVS) as a computerized, self-administered health literacy screener. Methods: Phase one involved 33 participants to create response options for a computerized, self-administered NVS (C-NVS). Phase two was a randomized crossover trial to test the consistency of C-NVS and original, interviewer-administered NVS (I-NVS) scores in 89 participants. Results: Linear mixed-effects regression model results showed a significant carryover effect (p < .001). Crossover trial data from time 1 showed that participants who initially received the C-NVS had significantly higher average scores (M = 5.7, SD = 0.6) than participants who received the I-NVS (M = 4.5, SD = 1.5; t(87) = 5.25, p < .001). Exploratory analysis results showed that when the washout period was longer than 33 days (75th percentile) the carryover effect was not statistically significant (p = .077). Conclusion and innovation: Findings suggest learning can occur when health literacy screeners are administered more than once in less than a month's time and computerized, self-administered health literacy screeners may produce ceiling effects. A universal precautions approach to health literacy therefore remains germane.

Corrigendum: Evaluation of N95 respirators on fit rate, real-time leakage, and usability among Chinese healthcare workers: study protocol of a randomized crossover trial.

[This corrects the article DOI: 10.3389/fpubh.2023.1266607.].

Intake of Pistachios as a Nighttime Snack Has Similar Effects on Short- and Longer-Term Glycemic Control Compared with Education to Consume 1-2 Carbohydrate Exchanges in Adults with Prediabetes: A 12-Wk Randomized Crossover Trial.

BACKGROUND: Nut intake is associated with better glycemic control and lower cardiovascular disease (CVD) risk. It remains unclear if nut intake timing affects glycemic control and CVD risk factors. Intake of pistachios as a nighttime snack may attenuate morning glucose production and lower fasting plasma glucose (FPG). OBJECTIVES: We assessed the effects of a nighttime (after dinner and before bedtime) pistachio snack (57 g/d) on glycemic control markers, vascular health, lipids/lipoproteins, and diet quality compared with education to consume 1-2 carbohydrate (CHO) exchanges (usual care) in individuals with prediabetes. METHODS: A 2-period, randomized crossover trial was conducted. Participants were provided 57 g/d of dry roasted unsalted pistachios (319 kcal; fat 26 g; CHO 16 g; protein 12 g; fiber 6 g) as a nighttime snack or received usual care for 12 wk. Primary (FPG) and secondary outcomes [hemoglobin A1c (HbA1c), insulin, Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), lipids/lipoproteins, vascular health, and Healthy Eating Index-2015 (HEI-2015)] were measured before and after each condition. RESULTS: A total of 66 participants (50.9 ± 11.6 y, FPG: 106.2 ± 6.4 mg/dL) were randomly assigned, and 51 participants completed the trial. No between-condition differences in FPG {0.9 mg/dL [95% confidence interval (CI): -1.2, 3.1]}, HbA1c, insulin, HOMA-IR, lipids/lipoproteins, blood pressure, or vascular health were observed. The HEI-2015 score was higher after the pistachio condition [6.8 points (95% CI: 1.5, 12.1)] than after usual care driven by higher component scores for seafood and plant proteins [2.0 points (95% CI: 1.0, 2.9)], refined grains [2.3 points (95% CI: 1.1, 3.5)], and the fatty acid ratio [1.7 points (95% CI: 0.0, 3.5)]. CONCLUSIONS: In adults with prediabetes, consuming 57 g/d of pistachios as a nighttime snack increased diet quality but had similar effects on glycemic markers, lipids/lipoproteins, blood pressure, and vascular health compared with the usual care comparator. Pistachios may be a healthful alternative to carbohydrate-rich nighttime snacks to increase alignment with Dietary Guidelines for Americans. This trial was registered at clinicaltrials.gov as NCT04056208.

The specially designed nudging tableware promotes healthy food choices: Evidence from a randomized crossover trial in normal-weight young adults.

PURPOSE: To evaluate the effects of the specially designed nudging tableware, including a plate and bowl, on individual food choices in normal-weight young adults and preliminarily explore its mechanisms. We hypothesized that the toolset could increase the choice of vegetables and decrease that of rice. METHODS: A randomized, single-blind, two-period crossover trial was carried out among 40 normal-weight university students in China. All subjects completed two buffets separated by an interval of one week, wearing the eye tracker. Vegetable choice, evaluated through the proportion of vegetables, was the primary outcome, and the weight of vegetables and rice were the secondary outcomes. The mechanisms of the decision-making process were preliminarily explored through eye tracking. RESULTS: The usage of the nudging tableware significantly increased the proportion of vegetables and decreased the amount of rice taken (P<0.05), while insignificantly increased the weight of vegetables (P = 0.079). Eye tracking shows that the nudging plate significantly prolonged the food-choosing process and fixation duration on vegetables (P<0.05), and the latter was positively correlated to the increased quantity of vegetables while using the nudging plate (r = 0.493, P<0.01). CONCLUSION: The specially designed nudging tableware might be an effective and practical tool to promote the choice of less rice and more vegetables. Mechanisms behind this change might include automatic and unconscious processes with the inconspicuously smaller capacity of the bowl and larger portion size of the vegetable segment, and increased attention triggered by the vegetable patterns and larger green underpainting.

Evaluation of N95 respirators on fit rate, real-time leakage, and usability among Chinese healthcare workers: study protocol of a randomized crossover trial.

Background: N95 respirators are used to limit the transmission of respiratory viruses in clinical settings. There are two to three major types of N95 available for all healthcare workers in Hong Kong. However, after the coronavirus outbreak and the consequent shortage of many commonly used respirators, several new N95 respirators were adopted temporarily in clinical settings without evaluation. Prior literature indicates that traditional N95 respirators used in hospitals in Hong Kong are not fit for Chinese people and have fit rates ranging from 50 to 60%. This study aims to investigate and compare the fit rate, real-time leakage, and mask usability of traditional and new N95 respirators among Chinese healthcare workers. Methods: This study will employ two sequential phases. Phase 1 has a cross-sectional exploratory design used to investigate the fit rate and mask usability of three types of respirators. Phase 2 will examine the effectiveness of respiratory protection by comparing traditional and new N95 respirators by a randomized crossover trial. Eligible participants will be randomly allocated through a controlled crossover experiment to either a traditional or new respirator group (n = 100 in each arm) for performing standard clinical procedures. The primary outcome (real-time leakage) will be recorded at 30 s intervals during nasopharyngeal suctioning and cardiopulmonary resuscitation. The secondary outcomes are the fit rate and mask usability. After a 2 min suctioning (15 s twice) and 4 min one-person CPR, the fit rate (assessed by standard N95 fit testing) and mask usability (measured by self-reported mask usability scale) will be recorded as data of post-procedure. After 10 min rest, measurement of real-time leakage (i.e., crossover), fit test, and usability will be repeated. Discussion: The result of real-time leakage will be a vital indicator of the respiratory protection of Chinese healthcare workers while performing prevalent clinical procedures, such as resuscitation. The fit rate and usability result will serve as an essential reference for consumable purchase policy in clinical settings.Trial registration: ISRCTN registry: ISRCTN40115047. Retrospectively registered on May 9, 2023. https://www.isrctn.com/ISRCTN40115047.

Efficacy of titratable mandibular advancement device versus continuous positive airway pressure therapy in the treatment of obstructive sleep apnea: A clinical crossover trial.

Background: To compare efficacy of continuous positive airway pressure (CPAP) and oral appliance (OA) in management of various grades of obstructive sleep apnea (OSA). Methods: Thirty polysomnography diagnosed cases of OSA were divided into three groups based on baseline apnea hypopnea index (AHI) as follows: group 1: mild OSA (AHI = 5-14.9), group 2: moderate OSA (AHI = 15-29.9), and group 3: severe OSA (AHI >30) with 10 patients in each group. Half of the patients in each group were randomly allocated to CPAP or OA therapy, and crossover of therapy was performed after two months. AHI, Epworth's Sleepiness Scale (ESS), and mean oxygen saturation (SPO2) were measured at baseline, after each arm of treatment and after the crossover. A questionnaire survey including information regarding pretreatment sleep symptoms and improvement after therapy was performed at above time frames. At the end of therapy, the patients were surveyed regarding satisfaction and perceived effectiveness with both modalities. Results: CPAP was more efficacious in reducing AHI and SPO2 as compared with OA across the three study groups. The improvement in most sleep-related symptoms was higher with CPAP. The satisfaction and perception on effectiveness of treatment were higher with OA than CPAP across three study groups (P-value<0.05 for all). Conclusions: OA is an effective alternative to CPAP across all grades of OSA in selected cases, which is more preferred owing to higher effectiveness and satisfaction among the patients.

Effectiveness of neurobic exercise program on memory performance in community-dwelling older adults with mild cognitive impairment: A randomized controlled crossover trial.

Background: Mild cognitive impairment (MCI) is an early stage of cognitive decline in individuals who are still able to perform their activities of daily living. They are at increased risk of developing dementia. Improving and maintaining cognitive functions are essential goals for older people with MCI to delay or prevent the transition to dementia. Objective: This study investigated the effect of the neurobic exercise program on memory performance among community-dwelling older adults with MCI. Methods: A single-blind, randomized, controlled, two-period crossover design was used. Thirty-two older adults who met the study criteria were randomly assigned to one of two sequence groups, A (n =16) and B (n = 16). Group A received three weeks of neurobic exercise, followed by a three-week washout period, and then three weeks of the traditional brain exercise program. Group B received the treatments in the reverse order but otherwise in a similar manner. Two aspects of memory performance were evaluated: subjective memory and objective memory. Blinded evaluators measured the outcomes four times at baseline, post-intervention (week 3), follow-up stage (week 7), and the end of the study (week 9). Descriptive statistics, independent t-tests, and repeated measures ANOVA were employed for data analyses. Results: For subjective memory, rmANOVA revealed a significant difference of within-subject (F1.437, 43.113 = 9.324, p <0.05) and interaction effect (time*group) (F1.437, 43.113 = 12.313, p <0.05) and also showed significant differences of within-subject (F1.794,53.811 = 28.931, p < .05) and interaction effect (time*group) (F1.794, 53.811 = 31.190, p <0.05) for objective memory. The study results revealed that the participants in both groups had significantly lower mean scores on the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE), indicating better or improved subjective memory. They also had significantly higher mean scores on the Common Objects Memory Test (COMT) after receiving the neurobic exercise program, indicating improvement in cognitive performance. Conclusion: The neurobic exercise intervention could improve subjective and objective memory among community-dwelling older adults with MCI more than those who received the traditional brain exercise program. Therefore, the neurobic exercise program can be used by nurses and multidisciplinary teams to enhance memory performance among older adults with MCI. Trial registration: Thai Clinical Trials Registry (TCTR) 20210326003.

Randomized Trial on the Effect of Oral Potassium Chloride Supplementation on the Thiazide-Sensitive Sodium Chloride Cotransporter in Healthy Adults.

Introduction: The putative "renal-K switch" mechanism links dietary potassium intake with sodium retention and involves activation of the sodium chloride (NaCl) cotransporter (NCC) in the distal convoluted tubule in response to low potassium intake, and suppression in response to high potassium intake. This study examined NCC abundance and phosphorylation (phosphorylated NCC [pNCC]) in urinary extracellular vesicles (uEVs) isolated from healthy adults on a high sodium diet to determine tubular responses to alteration in potassium chloride (KCl) intake. Methods: Healthy adults maintained on a high sodium (∼4.5 g [200 mmol]/d) low potassium (∼2.3 g [60 mmol]/d) diet underwent a 5-day run-in period followed by a crossover study, with 5-day supplementary KCl (active phase, Span-K 3 tablets (potassium 24 mmol) thrice daily) or 5-day placebo administrated in random order and separated by 2-day washout. Ambulatory blood pressure (BP) and biochemistries were assessed, and uEVs were analyzed by western blotting. Results: Among the 18 participants who met analysis criteria, supplementary KCl administration (vs. placebo) was associated with markedly higher levels of plasma potassium and 24-hour urine excretion of potassium, chloride, and aldosterone. KCl supplementation was associated with lower uEV levels of NCC (median fold change (KCl/Placebo) = 0.74 [0.30-1.69], P < 0.01) and pNCC (fold change (KCl/Placebo) = 0.81 [0.19-1.75], P < 0.05). Plasma potassium inversely correlated with uEV NCC (R2 = 0.11, P = 0.05). Conclusions: The lower NCC and pNCC in uEVs in response to oral KCl supplementation provide evidence to support the hypothesis of a functional "renal-K switch" in healthy human subjects.

Effects of a novel rice-based diabetes-specific formula on postprandial glucose and gastrointestinal hormones: a double-blinded multi-arm randomized crossover trial.

Introduction: We developed a novel rice-based medical food for diabetes (MFDM) powder formula, using locally available ingredients in Thailand, which can potentially improve patient access to diabetes-specific formula (DSF) by reducing cost and improving availability. Purpose: The goals of our studies were to 1) measure the glycemic index (GI) and glycemic load (GL) of the MFDM powder formula in healthy individuals, and 2) assess postprandial glucose, insulin, satiety, hunger, and gastrointestinal (GI) hormone responses in adults with prediabetes or early type 2 diabetes after consuming MFDM in comparison with a commercially available standard formula (SF) and a DSF. Methods: In Study 1, glycemic responses were assessed using the area under the curve (AUC), which was used to calculate GI and GL. Study 2 was a double-blinded multi-arm randomized crossover trial enrolling participants with either prediabetes or type 2 diabetes of ≤6 years. At each study visit, participants consumed either MFDM, SF, or DSF which contained 25 g of carbohydrates. Hunger and satiety were assessed using a visual analog scale (VAS). Glucose, insulin, and GI hormones were assessed using AUC. Results: All participants tolerated the MFDM well with no adverse events. In Study 1, the measured GI was 39 ± 6 (low GI) and GL was 11 ± 2 (medium GL). In Study 2, glucose and insulin responses were significantly lower after MFDM compared with SF (p-value<0.01 for both), however, those responses were similar between MFDM and DSF. MFDM suppressed hunger, promoted satiety, stimulated active GLP-1, GIP, and PYY, and suppressed active ghrelin although these changes were similar to SF and DSF. Conclusions: MFDM had a low GI and a low-to-medium GL. In people with prediabetes or early type 2 diabetes, MFDM elicited reduced glucose and insulin responses when compared with SF. Rice-based MFDM may be an option for patients who are at risk for postprandial hyperglycemia. Clinical Trial Registration: https://www.thaiclinicaltrials.org/show/TCTR20210731001, identifier TCTR20210731001; https://www.thaiclinicaltrials.org/show/TCTR20210730007, identifier TCTR20210730007.

Nasal oxytocin administration does not influence eye gaze or perceived relationship of male volunteers with physicians in a simulated online consultation: a randomized, placebo-controlled trial.

The patient-physician relationship is a critical determinant of patient health outcomes. Verbal and non-verbal communication, such as eye gaze, are vital aspects of this bond. Neurobiological studies indicate that oxytocin may serve as a link between increased eye gaze and social bonding. Therefore, oxytocin signaling could serve as a key factor influencing eye gaze as well as the patient-physician relationship. We aimed to test the effects of oxytocin on gaze to the eyes of the physician and the patient-physician relationship by conducting a randomized placebo-controlled crossover trial in healthy volunteers with intranasally administered oxytocin (with a previously effective single dose of 24 IU, EudraCT number 2018-004081-34). The eye gaze of 68 male volunteers was studied using eye tracking during a simulated video call consultation with a physician, who provided information about vaccination against the human papillomavirus. Relationship outcomes, including trust, satisfaction, and perceived physician communication style, were measured using questionnaires and corrected for possible confounds (social anxiety and attachment orientation). Additional secondary outcome measures for the effect of oxytocin were recall of information and pupil diameter and exploratory outcomes included mood and anxiety measures. Oxytocin did not affect the eye-tracking parameters of volunteers' gaze toward the eyes of the physician. Moreover, oxytocin did not affect the parameters of bonding between volunteers and the physician nor other secondary and exploratory outcomes in this setting. Bayesian hypothesis testing provided evidence for the absence of effects. These results contradict the notion that oxytocin affects eye gaze patterns or bonding.

Examining the use of cannabidiol and delta-9-tetrahydrocannabinol-based medicine among individuals diagnosed with dementia living within residential aged care facilities: Results of a double-blind randomised crossover trial.

OBJECTIVE: Dementia affects individuals older than 65 years. Currently, residential aged care facilities (RACF) use psychotropic medications to manage behavioural and neuropsychiatric symptoms of dementia (BPSD), which are recommended for short-term use and have substantial side effects, including increased mortality. Cannabinoid-based medicines (CBM) have some benefits that inhibit BPSD and cause minimal adverse effects (AEs), yet limited research has been considered with this population. The study aimed to determine a tolerable CBM dose (3:2 delta-9-tetrahydrocannabinol:cannabidiol), and assessed its effect on BPSD, quality of life (QoL) and perceived pain. METHODS: An 18-week randomised, double-blinded, crossover trial was conducted. Four surveys, collected on seven occasions, were used to measure changes in BPSD, QoL and pain. Qualitative data helped to understand attitudes towards CBM. General linear mixed models were used in the analysis, and the qualitative data were synthesised. RESULTS: Twenty-one participants (77% female participants, mean age 85) took part in the trial. No significant differences were seen between the placebo and CBM for behaviour, QOL or pain, except a decrease in agitation at the end of treatment in favour of CBM. The qualitative findings suggested improved relaxation and sleep among some individuals. Post hoc estimates on the data collected suggested that 50 cases would draw stronger conclusions on the Neuropsychiatric Inventory. CONCLUSIONS: The study design was robust, rigorous and informed by RACF. The medication appeared safe, with minimal AEs experienced with CBM. Further studies incorporating larger samples when considering CBM would allow researchers to investigate the sensitivity of detecting BPSD changes within the complexity of the disease and concomitant with medications.