Controlled Crossover Trial Research Articles

The effect of calcium supplementation on bone calcium balance and calcium and bone metabolism during load carriage in women: a randomised controlled crossover trial.

Calcium supplementation before exercise attenuates the decrease in serum calcium and increase in PTH and bone resorption. This study investigated the effect of calcium supplementation on calcium and bone metabolism during load carriage in women. Forty-eight women completed two load carriage sessions (load carriage 1 n = 48; load carriage 2 n = 40) (12.8km in 120min carrying 20kg) 60min after consuming either 1000mg calcium (Calcium) or nothing (Control) in a randomised order. Pre- and post-exercise urine samples were analysed for calcium isotope ratio (δ44/42Ca). Fasted blood samples were taken before (pre-exercise), during (0, 20, 40, 60, 80, 100, 120min), and after (+15, +30, +60, +90min) exercise and analysed for markers of calcium and bone metabolism. There was no effect of load carriage or supplementation on urine δ44/42Ca (P≥.110). Serum δ44/42Ca did not change with load carriage in Control (P=.617) but increased in Calcium (P=.003) and was higher at 120min in Calcium vs Control (P=.018). Ionised calcium (iCa) decreased from pre-exercise to all exercise time-points (P<.001); iCa was higher in Calcium than Control throughout (P<.001). PTH increased from pre-exercise to 120min in Control (P<.001) but decreased from pre-exercise to all time-points in Calcium (P<.001). PTH was higher in Control than Calcium from 0 to +90min (P<.001). βCTX decreased from pre-exercise to 20 to +15min in Control (P≤.004); βCTX decreased from pre-exercise to 0 to +90min in Calcium (P<.001). βCTX was lower in Calcium than Control from 20 to +90min (P≤.036). A 1000mg calcium supplement before load carriage promotes bone calcium balance and prevents disruptions to bone and calcium homeostasis.

Vestibular Infant Screening-Rehabilitation (VIS-REHAB): protocol for a randomised controlled trial on Vestibular Rehabilitation Therapy (VRT) in vestibular-impaired children

IntroductionA vestibular deficit can have a substantial impact on the overall development of children. Therefore, it is of utmost importance that vestibular-impaired problems are treated early and effectively through Vestibular...

One minute of light-intensity stair-stepping decreases postprandial glycaemia in the evening in non-diabetic adults: A randomized controlled trial.

Prior studies have investigated the efficacy of a single 1min bout of stair-stepping on reducing postprandial blood glucose (BG)in the morning, but none have investigated this effect in the evening when glycaemic responses are larger due to circadian regulation and β-cell responsiveness. This work investigated the efficacy of a 1min bout of self-selected, low-intensity stair-stepping performed in the evening on reducing the change from baseline to the 60min time point postprandial BG. Thirty people (43% male, 29 (10) years) participated in a randomized crossover-controlled trial. Participants completed two separate evening trials following an oral glucose tolerance test (OGTT) (75g of dextrose dissolved in water): (a) 0min of stair-stepping seated control condition, and (b) 1 min of stair-stepping condition. One minute of stair-stepping attenuated the change from baseline to 60 min postprandial BG versus control condition (2.5 (2.8) vs. 4.3 (2.3) mmol/L (P<0.001). Area under the curve (AUC) and incremental area under the curve (iAUC) were lower for the 1 min condition versus control (mean difference = -0.4,95% CI: 0.1-0.8 (P=0.023) and (mean difference = -0.6, 95% CI 0.1-1.1 mmol/L-1 min-1 (P=0.043), respectively. The modified BORG rate of perceived exertion scale showed participants perceived the exercise as light intensity (1.9 (1.1)). A single, 1 min bout of low-intensity stair stepping at a self-selected pace reduced evening postprandial BG levels following an OGTT in young non-diabetic adults.

Cold induces increased ad libitum energy intake independent of changes in energy expenditure: a controlled crossover trial in adults.

Measures of energy metabolism [energy expenditure (EE), respiratory exchange ratio (RER)] have been associated with ad libitum energy intake (EI) and weight gain in previous observational studies, suggesting that energy-sensing mechanisms drive EI to meet metabolic energy demands. We aimed to employ mild cold exposure as an intervention to alter energy metabolism and evaluate its causal effects on concurrent and next day ad libitum EI. In a controlled crossover study, 47 volunteers (16 female; age 37.2±10.7 years; BMI 32.4±8.6 kg/m2) completed four 24-h EE measurements in a respiratory chamber. Participants ate ad libitum for 24-h using an objective vending machine paradigm while in the chamber during both cold exposure (19°C) and thermoneutral conditions (23.5°C) and after two eucaloric chamber stays with exposure to each temperature. Energy metabolism changes were calculated from eucaloric conditions (cold vs. thermoneutral). Compared to thermoneutral conditions, participants consumed 13% more while residing in the chamber during cold (mean difference: 411±987 kcal/day, p=0.006), but not the day after cold exposure. Neither eucaloric EE, RER, nor carbohydrate oxidation (CARBOX) were significantly changed by cold exposure. However, greater increases in RER and CARBOX during cold exposure were associated with greater ad libitum EI on the day after cold exposure (r=0.29, p=0.049 and r=0.33, p=0.02), but not with EI during cold exposure. Cold-induced changes in 24-h EE were not associated with changes in ad libitum EI during or after cold exposure. Ad libitum EI increased during but not following mild cold exposure. There was an effect of 24-h RER and CARBOX during cold exposure that was related to greater ad libitum EI following cold. These results indicate an acute effect of cold on concurrent EI independent of changes in metabolic rate, but also a residual influence of cold on subsequent EI via fuel preference. CLINICAL TRIAL REGISTRATION NUMBER (FROM CLINICALTRIALS.GOV): NCT02939404.

Investigating the Impact of Glycogen-Depleting Exercise Combined with Prolonged Fasting on Autophagy and Cellular Health in Humans: A Randomised Controlled Crossover Trial.

Although prolonged fasting has become increasingly popular, the favourable biological adaptations and possible adverse effects in humans have yet to be fully elucidated. To investigate the effects of a three-day water-only fasting, with or without exercise-induced glycogen depletion, on autophagy activation and the molecular pathways involved in cellular damage accumulation and repair in healthy humans. A randomised, single-centre, two-period, two-sequence crossover trial. The primary outcome is autophagic activity, assessed as flux in peripheral blood mononuclear cells (PBMCs) measured in the context of whole blood. Secondary outcomes include changes in body composition, heart rate variability, endothelial function, and genomic, epigenomic, metabolomic, proteomic, and metagenomic adaptations to fasting in plasma, platelets, urine, stools, and PBMCs. Detailed profiling of circulating immune cell populations and their functional states will be assessed by flow cytometry. All clinical investigations will be undertaken at the Charles Perkins Centre Royal Prince Alfred Hospital clinic, University of Sydney, Australia. Twenty-four individuals aged 18 to 70 years, with a BMI of 20-40 kg/m2, free of major health conditions other than obesity. While autophagic flux induction through fasting has garnered interest, there is a notable lack of human studies on this topic. This trial aims to provide the most detailed and integrated analysis of how three days of prolonged water-only fasting, combined with glycogen-depleting exercise, affects autophagy activation and other crucial metabolic and molecular pathways linked to cellular, metabolic, and immune health. Insights from this study may pave the way for safe and effective strategies to induce autophagy, offering potential preventive interventions for a range of chronic conditions.

Immediate Effects of Calf Tissue Flossing on Ankle Joint Torque and Dorsiflexion Range of Motion in Healthy Individuals: A Randomized Controlled Crossover Trial.

Tissue flossing involves wrapping a rubber band around a muscle group for a few minutes while performing joint motion, enhancing ankle joint torque and range of motion. As limited ankle dorsiflexion range of motion and plantar flexion muscle weakness are risk factors for sports injury, assessing the therapeutic effects of tissue flossing is important. This study aimed to evaluate the immediate effects of calf tissue flossing on enhancing ankle joint torque and dorsiflexion range of motion. We conducted a randomized controlled crossover trial involving 19 healthy adult males who received two interventions (low and high-pressure tissue flossing bands) and a control condition (underwrap). Each intervention was applied for 2 minutes on the non-dominant calf, with 5-10 days between sessions. A pressure sensor placed on the posterior calf monitored the wrapping compression force. The intervention exercise comprised six voluntary isometric contractions of the ankle at three angles (20° plantar flexion, neutral 0°, and 10° dorsiflexion) for 3 seconds each using a dynamometer. The maximal isometric ankle plantar flexion torque and dorsiflexion range of motion were evaluated pre- and post-intervention. Significant interactions were observed in ankle plantar flexion torque at 10° dorsiflexion (p < 0.01) but not at 0° or 20° plantar flexion. The low- and high-pressure bands significantly enhanced ankle plantar flexion torque by 4.3 Nm (effect size [ES]: 0.14, p = 0.02) and 4.9 Nm (ES: 0.15, p < 0.05), respectively, and also enhanced the ankle dorsiflexion range of motion by 1.7° (ES: 0.43, p < 0.01) and 1.3° (ES: 0.35, p = 0.02), respectively, compared to the control. The low- and high-pressure band conditions had comparable effects on torque and range of motion. A few minutes of the calf tissue flossing intervention significantly enhanced ankle plantar flexion torque and dorsiflexion range of motion, although the effect sizes were trivial to small.

EFFECT OF DECEPTIVE VERSUS NON-DECEPTIVE PLACEBO ON PSYCHOMOTOR AND COGNITIVE FUNCTIONS IN HEALTHY ADULT HUMAN VOLUNTEERS: AN OPEN-LABEL CROSS-OVER RANDOMIZED CONTROLLED TRIAL.

This study was planned to evaluate the effect of a placebo administered with deception vs. without deception on psychomotor and cognitive functions in healthy human volunteers compared to no treatment as placebo responses tend to be circumstantial. An open-label, 3-period, 6-sequence randomized controlled cross-over trial was conducted with 54 participants in a tertiary care center. After the initial screening for eligibility, the patients were randomized into sequences. Psychomotor, executive, and memory function tests were performed before and 30 minutes after the administration of the intervention on three different days (one intervention each day). Participants showed a significant reduction in reaction time in most of the computerized tests for evaluation of psychomotor function (simple reaction time: one hand: 47.15; 95% CI: 30.99 to 63.32; p <0.001, both hands: 63.90; 95%CI: 46.23 to 81.57; p <0.001|| choice reaction time (79.83; 95%CI: 41.27 to 118.40; p<0.001) and digit picture substitution test (182.12; 95% CI: 116.0 to 248.24; p < 0.001)), executive function and memory with deceptive placebo when compared to nondeceptive placebo. No statistical difference in the paper and pencil tests was observed; however, there was a significant reduction in deceptive placebo over nondeceptive placebo or no intervention groups for trail-making tests for the executive functions. No significant difference was observed for motor functions. A deceptive placebo has a significant effect on psychomotor function compared to a nondeceptive placebo and no treatment; thus there could be differences in placebo responses in clinical trial versus clinical practice or double blind versus open label placebo. The calculation of actual drug effect in a clinical trial needs the development of an algorithm balancing for placebo response.

Ankle Taping Does Not Affect Running Kinematics During a Treadmill Protocol in Well-Trained Runners: A Secondary Analysis from a Randomized Cross-Over Controlled Trial.

Background: The purpose of this randomized cross-over controlled trial was to evaluate the biomechanical effects of ankle taping using rigid tape (RT) or kinesiotape (KT) compared to no taping during treadmill running in well-trained amateur runners. Methods: A total of 22 participants (15 men and 7 women) completed three running sessions on a treadmill, each lasting 30 min, under different conditions: no taping (CG), RT, and KT. Sagittal and frontal plane kinematics were analyzed using the Kinovea software to assess the ankle dorsiflexion, knee flexion, hip extension, tibial angle, foot strike pattern, heel eversion, and pelvic drop across three intervals (0-10, 10-20, and 20-30 min). Results: The results demonstrated no significant differences in sagittal plane variables (ankle dorsiflexion, knee flexion, hip extension, and cadence) or frontal plane variables (heel eversion and pelvic drop) between the CG, RT and KT groups at any time point. Although heel eversion significantly increased over time due to fatigue, the taping conditions did not affect running kinematics. Conclusions: These findings suggest that neither RT nor KT alters running biomechanics in well-trained runners over prolonged treadmill running. The study highlights that taping, commonly used to prevent ankle injuries, does not significantly modify lower limb kinematics in the absence of injury. Further research is needed to evaluate the effects of taping in novice or injured runners and under more demanding conditions, such as overground running.

Optimal duration of whole-body cryostimulation exposure to achieve target skin temperature: influence of body mass index—a randomized cross-over controlled trial

BackgroundThe efficacy of whole-body cryostimulation (WBC) may be influenced by individual characteristics. The aim of this study is to determine the optimal exposure time required to reach the analgesic threshold of 13.6 °C, which has been proposed to be a target temperature to be reached at skin level. Our objective is also to follow the skin temperature changes during and after WBC considering the participants body mass index (BMI).MethodsThirty healthy men were assigned into 2 groups based on their BMI [normal weight (n = 15; BMI = 21.53 ± 1.63 kg·m−2) and overweight (n = 15; BMI = 27.98 ± 1.16 kg·m−2)]. In a random order, each participant experienced a 4-min WBC exposure, as well as a control session with no cold exposure. Skin temperature was measured using a thermal imaging camera during and after cold exposure.ResultsNormal weight participants reached the threshold in 4 min, whereas overweight participants reached it in 3 min 30 s. Following WBC, a rapid mean skin temperature (MsT°) increase was observed for both groups, immediately after exposure. However, after 30 min, MsT° remained significantly lower than at baseline.ConclusionOur findings suggest that appropriate WBC dosage may differ according to BMI. Understanding the impact of such variable on cold exposure outcomes can help to optimize WBC treatments and maximize potential benefits.

Effects of a 30-min rest with a nap chair on task performance, sleepiness, and neurophysiological measures in men with suspected brain fatigue: a randomized controlled crossover trial

BackgroundIt has been suggested that a short nap in the afternoon may improve sleepiness, alertness, and task performance. The present study evaluated the effects of a 30-min rest with a new nap chair on task performance, sleepiness, and neurophysiological measures.MethodsA randomized controlled crossover trial with a 1-week interval was carried out at the BOOCS Clinic Fukuoka in Japan. The subjects were male workers aged 20 to 64 years with suspected brain fatigue, which was defined by the Profile of Mood Status 2. The intervention was a 30-min rest with an office chair or a nap chair. The primary outcome was the performance in the Uchida-Kraepelin test. The secondary outcomes included the Karolinska Sleepiness Scale and 15-min heart rate variability (HRV). The changes after the nap-chair rest and office-chair rest were compared. Repeated measures analysis of variance with nesting was used in the statistical analysis.ResultsTwenty participants were eligible and entered the crossover trial. The overall 15-min score in the Uchida-Kraepelin test improved after the nap-chair rest and after the office-chair rest to almost the same extent (5.9 vs. 5.5 points, P = 0.68). The Karolinska Sleepiness score significantly decreased after the nap-chair rest, and the between-treatment difference in the decrease was highly significant (P = 0.0004). The average duration of sleep during rest was prominently longer in the nap-chair rest than in the office-chair rest (19.0 vs. 7.6 min, P = 0.002). No participants experienced REM sleep during the rest. LF and HF powers of the HRV were greater during the nap-chair rest than during the office-chair rest, the difference in the HF power being substantial.ConclusionA 30-min rest with the nap chair did not appreciably improve the performance in the Uchida-Kraepelin test as compared with the office-chair rest. The nap-chair rest induced a substantially longer sleep accompanied with a parasympathetic activation, thereby resulting in a material improvement in sleepiness after the rest.

Acute caffeine supplementation offsets the impairment in 10-km running performance following one night of partial sleep deprivation: a randomized controlled crossover trial.

Whether acute caffeine supplementation can offset the negative effects of one-night of partial sleep deprivation (PSD) on endurance exercise performance is currently unknown. Ten healthy recreational male runners (age: 27 ± 6years; : 61 ± 9mL/kg/min) completed 4 trials in a balanced Latin square design, which were PSD + caffeine (PSD-Caf), PSD + placebo (PSD-Pla), normal sleep (NS) + caffeine (NS-Caf) and NS + placebo (NS-Pla). 3 and 8h sleep windows were scheduled in PSD and NS, respectively. 10-km treadmill time trial (TT) performance was assessed 45min after caffeine (6mg/kg/body mass)/placebo supplementation in the morning following PSD/NS. Blood glucose, lactate, free fatty acid and glycerol were measured at pre-supplementation, pre-exercise and after exercise. PSD resulted in compromised TT performance compared to NS in the placebo conditions by 5% (51.9 ± 7.7 vs. 49.4 ± 6.9min, p = 0.001). Caffeine improved TT performance compared to placebo following both PSD by 7.7% (PSD-Caf: 47.9 ± 7.3min vs. PSD-Pla: 51.9 ± 7.7min, p = 0.007) and NS by 2.8% (NS-Caf: 48.0 ± 6.4min vs. NS-Pla: 49.4 ± 6.9min, p = 0.049). TT performance following PSD-Caf was not different from either NS-Pla or NS-Caf (p = 0.185 and p = 0.891, respectively). Blood glucose, lactate, and glycerol concentrations at post-exercise, as well as heart rate and the speed/RPE ratio during TT, were higher in caffeine trials compared to placebo. Caffeine supplementation offsets the negative effects of one-night PSD on 10-km running performance.

Immediate Correction of Idiopathic Scoliosis With Nighttime Braces Created by a Fully Automated Generative Design Algorithm: A Randomized Controlled Crossover Trial.

Single-center, double-blinded, prospective crossover randomized controlled trial. To clinically validate the efficacy of nighttime braces designed automatically by a generative design algorithm to treat idiopathic scoliosis (IS). The tested hypothesis was the clinical equivalence of immediate in-brace correction for the new automatically generated brace design versus a standard Providence-type brace. Documented efficacy of brace treatment varies between centers, and depends on the empirical expertise of the treating orthotist. Our group previously developed a fully automated generative brace design algorithm that leverages a patient-specific finite-element model (FEM) to optimize brace geometry and correction before its fabrication. Fifty-eight skeletally immature patients diagnosed with IS, aged between 10 and 16 years were recruited. All patients received both a nighttime brace automatically generated by the algorithm (test) and a Providence-type brace designed by an expert orthotist (control). Radiographs were taken for each patient with both braces in a randomized crossover approach to evaluate immediate in-brace correction. The targeted 55 patients (48 females, 7 males) completed the study. The immediate Cobb angle correction was 57% 19 (test) versus 58% 21 (control) for the main thoracic (MT) curve, whereas it was 89% 25 (test) versus 87% 28 (control) for the thoracolumbar/lumbar (TLL) spine. The immediate correction with the test brace was noninferior to that of the Control brace ( P 0.001). The order in which the braces were tested did not have a residual effect on the immediate correction. The fully automated generative brace design algorithm proves to be clinically relevant, allowing for immediate in-brace correction equivalent to that of braces designed by expert orthotists. Patient 2 years follow-up will continue. This method's integration could help design and rationalize the design of braces for the treatment of IS. Level 2.

Dietary Protein in a Challenge Meal Does Not Alleviate Postprandial Impairments in Vascular Endothelial Function in Healthy Older Adults with Cardiometabolic Risk: A Randomized Crossover-Controlled Trial

BackgroundPostprandial vascular endothelial dysfunction is an early marker of atherosclerosis. Meal protein has been reported to reduce endothelial dysfunction in adults, and the effect could be mediated by the amino acid content. ObjectivesThis trial aims to assess the effect of a specifically designed plant-protein blend that contains high leucine, arginine, and cysteine on postprandial endothelial function in the elderly. MethodsIn a randomized, double-blind, 3-period crossover (2-wk washout), controlled trial, we compared the vascular effects of 3 high-saturated-fat high-sucrose (HFHS) meals containing either our specific plant-protein blend, or milk protein, or without added protein. The trial was conducted on 29 healthy adults aged >65 y presenting ≥2 cardiometabolic risk factors. Postprandial vascular function was evaluated at fasting, 3 h, and 5 h postprandially, using brachial flow-mediated dilation (FMD), hand microvascular reactivity (using Flowmetry Laser Doppler, FLD), and finger reactive hyperemia index (using Peripheral Arterial Tonometry, RHI). Immune cell count and gene expression in peripheral blood mononuclear cells (PBMCs) were also assessed postprandially. Data were analyzed using mixed linear models with repeated measurements on participants for meal composition and time of sampling. This trial was registered at clinicaltrials.gov as NCT04923555. ResultsFMD incremental AUC value decreased after meals (time effect P < 0.01), with no significant differences between meals. RHI also decreased with time (P < 0.01). PBMC count and monocyte chemoattractant protein-1 (MCP1), IL-1β, and IL-6 expression increased after meals showing postprandial endothelial activation (P < 0.05). Overall, meal composition had no effect on any of the postprandial changes (Ps>0.10). ConclusionsIn healthy adults aged >65 y presenting cardiometabolic risk, adding protein to an HFHS challenge meal does not mitigate postprandial impairments in vascular endothelial function and inflammatory activation. Further studies are needed to explore the potential differences with younger adults.

Standardised and Objective Dietary Intake Assessment Tool (SODIAT): Protocol of a dual-site dietary intervention study to integrate dietary assessment methods

Introduction Current dietary assessment methods face challenges in accurately capturing individuals’ dietary habits, undermining the efficacy of public health strategies. The ‘Standardised and Objective Dietary Intake Assessment Tool’ (SODIAT)-1 study aims to assess the effectiveness of three emerging technologies (urine and capillary blood biomarkers, and wearable camera technology) and two online self-reporting dietary assessment tools to monitor dietary intake. Methods This randomised controlled crossover trial will recruit 30 participants (aged 18-70 years and BMI of 20-30 kg/m2) from Imperial College London and the University of Reading. Exclusion criteria include recent weight change, food allergies/intolerances, following restrictive diets, certain health conditions and medication use. Interested volunteers will be directed to an online screening questionnaire via REDCap and eligible participants will attend a pre-study visit. Volunteers will consume, in a random order, two highly-controlled diets (compliant and non-compliant with UK guidelines) for four days each. Each study arm will be separated by at least one-week. During each test period, dietary intake will be monitored continuously using wearable cameras and self-recorded using eNutri (food frequency questionnaire) and Intake24 (24-hour dietary recall). Urine and capillary blood samples will be collected for biomarker analysis. Data analysis will assess the accuracy of dietary reporting across these methods using Lin’s concordance correlation coefficient. Discussion and ethical considerations This study introduces a novel approach to dietary assessment, addressing the limitations of traditional methods by reducing misreporting and enhancing inclusivity, particularly for underrepresented populations with literacy or language barriers. However, challenges persist, such as variability in biomarker data due to failure to adhere to sample storage requirements and the practicalities of continuously wearing cameras. To protect privacy, participants will be instructed to remove cameras at inappropriate times, and artificial intelligence will be used to blur all images captured apart from food.

Effect of Outdoor Cycling, Virtual and Enhanced Reality Indoor Cycling on Heart Rate, Motivation, Enjoyment and Intention to Perform Green Exercise in Healthy Adults.

Background: Despite the benefits of physical activity (PA), Italy ranks low in leisure-time PA among European countries. Integrating virtual (VR)/enhanced (ER) reality with exercise equipment could boost PA engagement. Limited studies have explored how VR/ER-integrated cycling activity, compared to outdoor settings, influences PA among university students. Therefore, this study aimed to evaluate the acute effects of a brief cycling session outdoors and indoors on psychological and physiological outcomes, and secondly, investigate the potential of VR/ER-mediated nature experiences as a tool to promote green exercise. Methods: In February 2024, thirty-one subjects (20 M and 11 F; age 24.3 ± 3.2 years; BMI 23.5 ± 3.6 kg/m2) were involved in this randomized crossover-controlled trial, where they were assigned to three different conditions: ER cycling (ERC), VR cycling (VRC), and outdoor cycling (OUTC). Heart rate (HR), Physical Activity Enjoyment (PACE), Intrinsic Motivation Inventory (IMI), and Intention to Perform Green Exercise (INT-GE) were assessed at the end of each condition. Results: The OUTC condition showed significantly greater PACE, IMI, and INT-GE than ERC/VRC (p < 0.001), lower HRmean than ERC/VRC (p < 0.001 and p < 0.05, respectively), and lower HRmax than ERC (p < 0.05). Conclusions: VRC and ERC enhanced engagement and physiological responses during indoor cycling, but outdoor cycling offered superior benefits in motivation, enjoyment, and future engagement intentions. No significant differences were found between VRC and ERC in promoting intentions for outdoor activities, suggesting both technologies could be equally effective.

Accuracy And Oral Health-Related Quality of Life in Patients with Selective Laser Melted Versus Conventional Metallic Maxillary Single Denture Base: A Randomized Controlled Crossover Trial

Accuracy And Oral Health-Related Quality of Life in Patients with Selective Laser Melted Versus Conventional Metallic Maxillary Single Denture Base: A Randomized Controlled Crossover Trial

A 3-Week Ketogenic Diet Increases Skeletal Muscle Insulin Sensitivity in Individuals With Obesity: A Randomized Controlled Crossover Trial.

A ketogenic diet (KD) can induce weight loss and improve glycemic regulation, potentially reducing the risk of developing type 2 diabetes. To elucidate the underlying mechanisms behind these beneficial effects of a KD, we investigated the impact of a KD on organ-specific insulin sensitivity (IS) in skeletal muscle, liver, and adipose tissue. We hypothesized that a KD would increase IS in skeletal muscle. The study included 11 individuals with obesity who underwent a randomized, crossover trial with two three-week interventions: 1) KD and 2) standard diet. Skeletal muscle IS was quantified as the increase in glucose disposal during a hyperinsulinemic-euglycemic clamp (HEC). Hepatic IS and adipose tissue IS were quantified as the relative suppression of endogenous glucose production (EGP) and the relative suppression of palmitate flux during the HEC. The KD led to a 2.2 kg weight loss, increased insulin-stimulated glucose disposal, whereas the relative suppression of EGP during the HEC was similar. In addition, the KD decreased insulin-mediated suppression of lipolysis. In conclusion, a KD increased skeletal muscle IS in individuals with obesity.

A Single Sauna Session Does Not Improve Postprandial Blood Glucose Handling in Individuals with Type 2 Diabetes Mellitus: A Cross-Over, Randomized, Controlled Trial.

Passive heat treatment has been suggested to improve glycemic control in individuals with type 2 diabetes mellitus (T2DM). Previous studies have focused predominantly on hot water immersion and traditional sauna bathing, as opposed to the more novel method of infrared-based sauna bathing. Here, the impact of a single infrared sauna session on post-prandial glycemic control was assessed in older individuals with T2DM. In this randomized controlled crossover trial, 12 participants with T2DM (male/female: 10/2, age: 69±7 y, BMI: 27.5±2.9 kg/m2) rested in an infrared sauna twice: once in a heated (60°C) and once in a thermoneutral (21°C) condition for 40 min, immediately followed by a 2-h oral glucose tolerance test (OGTT). Venous blood samples were obtained to assess plasma glucose and insulin concentrations and to determine the whole-body composite insulin sensitivity index. Body core and leg skin temperature were higher following the heated condition compared to the thermoneutral condition (38.0±0.3 vs. 36.6±0.2°C and 39.4±0.8 vs. 31.3±0.8°C, respectively; P<0.001 for both). The incremental area under the curve (iAUC) of plasma glucose concentrations during the OGTT was higher after the heated condition compared to the thermoneutral condition (17.7±3.1 vs. 14.8±2.8 mmol/L/120 min; P<0.001). No differences were observed in plasma insulin concentrations (heated: 380±194 vs. thermoneutral: 376±210 pmol/L/120 min; P=0.93) or whole-body composite insulin sensitivity indexes (4.5±2.8 vs. 4.5±2.1; P=0.67). A single infrared sauna session does not improve postprandial blood glucose handling in individuals with T2DM. Future studies should assess the effect of more prolonged application of infrared sauna bathing on daily glycemic control.

Clinical Effectiveness of a 3-Step Versus a 6-Step Hand Hygiene Technique: A Randomized Controlled Cross-over Study

Abstract Background The aim of this study is to assess the clinical effectiveness of the 3-step hand hygiene (HH) technique (3-HT) compared with the 6-step HH technique (6-HT; World Health Organization 6-step technique) using an alcohol-based hand rub. Methods A randomized controlled crossover trial was conducted from November to December 2023 in 10 wards of a tertiary A-level hospital according to CONSORT guidelines. The 240 healthcare workers (HCWs) were randomly divided into the 3-HT intervention group or the 6-HT control group. The trial was conducted in 2 stages, and the effectiveness of each indicator in the 2 groups was compared after a washout period of 2 weeks. Results Compared with the 6-HT, the 3-HT has demonstrated significant superiority in all indicators of HH compliance as well as the accuracy rate of HH practices. The total HH median times for the 3-HT and 6-HT were 16.00 (interquartile range, 15.00–20.00) and 32.50 (30.00–40.00) seconds, respectively (P &amp;lt; .05). The reduction factors for bacterial colony-forming unit counts did not differ and the colony-forming unit counts were not significantly different. Bacillus, Staphylococcus, and Micrococcus were detected before and after the use of hand rubs. HCWs preferred the 3-HT over the 6-HT. There were no significant difference in healthcare-associated infections rate between the 2 techniques. Conclusions The 3-HT was significantly superior to the 6-HT in terms of the HH eligibility rate, compliance, and HH time. The safety and feasibility of the 3-HT were verified by assessing microorganism count.

Synergistic Effects of Time-Restricted Feeding and Resistance Training on Body Composition and Metabolic Health: A Systematic Review and Meta-Analysis.

This systematic review and meta-analysis examined the synergistic impact of time-restricted feeding (TRF) combined with resistance training (RT) (TRF + RT) on body composition and metabolic health in adults, contrasting it with habitual eating patterns (CON) and RT (CON + RT). Adhering to PRISMA guidelines, five databases were searched up to 28 April 2024. Randomized controlled trials or crossover trials assessing the effects of TRF + RT for at least 4 weeks in adults were selected. Data were pooled as standardized mean differences (SMDs) or weighted mean differences (WMDs) with 95% confidence intervals (CIs). The risk of bias was evaluated using the revised Cochrane risk-of-bias tool. Seven studies with 164 participants were included in the final analysis. TRF + RT significantly reduced body mass (WMD -2.90, 95% CI: -5.30 to -0.51), fat mass (WMD -1.52, 95% CI: -2.30 to -0.75), insulin (SMD -0.72, 95% CI: -1.24 to -0.21), total cholesterol (WMD -9.44, 95% CI: -13.62 to -5.27), low-density lipoprotein cholesterol (LDL-C) (WMD -9.94, 95% CI: -13.47 to -6.41), and energy intake (WMD -174.88, 95% CI: -283.79 to -65.97) compared to CON + RT. No significant changes were observed in muscle mass, strength, or other metabolic markers. TRF + RT, in contrast to CON + RT, significantly improved body composition, insulin, and cholesterol levels without affecting muscle mass or strength.