Double-blind Crossover Trial Research Articles

Highly branched cyclic dextrin supplementation and resistance training: a randomized double-blinded crossover trial examining mechanical, metabolic, and perceptual responses.

The aim of this study was to investigate the potential ergogenic effects of intra-session supplementation of highly branched cyclic dextrin (HBCD) on mechanical (number of repetitions completed and repetition velocity), metabolic (lactate concentration), and perceptual (gastrointestinal complaints and ratings of perceived exertion [RPE]) responses to resistance training. This study used a randomized, double-blinded, placebo-controlled crossover study design. Thirty physically active individuals (15 men and 15 women) completed two experimental sessions that only differed in the supplement condition (placebo or HBCD). In each experimental session, subjects were prescribed five sets of eight repetitions with the 12-repetition maximum load during the bench press, bench pull, and squat exercises. During the sessions, participants consumed a total of 750 mL of the beverage, which either contained diluted 45 g of cyclic dextrin (HBCD condition) or only 2.5 g of the calorie-free excipients (placebo condition). The supplement (placebo or HBCD) was ingested during the inter-set rest periods (50 mL before each set). The main findings indicated that intra-session HBCD supplementation (i) was well-tolerated without causing gastrointestinal complaints, (ii) led to improved repetition velocity during RT in men but not in women, (iii) tended to generate comparable or higher lactate values, and (iv) did not significantly influence the perception of fatigue. These results suggest that HBCD can be considered an ergogenic supplement, particularly for enhancing mechanical performance in men, without noticeably affecting the perception of fatigue or discomfort.

Do ankle braces affect functional performance? A randomised double-blinded cross-over trial

ObjectivesTo compare the effects of the KISS ankle brace, Aircast ankle brace, and no brace condition, on functional performance measures and perceptions of stability, confidence and reassurance in people with and without chronic ankle instability. DesignRandomised double-blinded cross-over trial. MethodA total of 42 participants (21 uninjured and 21 with chronic ankle instability) were recruited from the general population and completed a series of functional performance tests, including side hop (seconds), Star excursion balance test reach distance, triple hop for distance (centimetres), modified T-agility test (seconds), standing and maximum vertical jump reach (centimetres), while wearing two ankle brace conditions and no brace (control). Results were recorded and analysed by a blinded investigator. ResultsThere was no significant difference between conditions for average time on the side hop test (F(2,122) ​= ​0.04, P ​= ​0.96); best reach distance on SEBT in anterior (F (2,122) ​= ​0.04, P ​= ​0.96), postero-medial (F(2,122) ​= ​0.08, P ​= ​0.93) and postero-lateral (F(2,122) ​= ​0.08, P ​= ​0.92) directions; best distance performed on the triple hop (F(2,122) ​= ​0.03, P ​= ​0.97); best standing vertical jump performance (F(2,110) ​= ​0.04, P ​= ​0.97); best maximum vertical jump performance (F(2,110) ​= ​0.01, P ​= ​0.99); or best time for the modified T-agility run (F(2,122) ​= ​1.61, P ​= ​0.21). ConclusionsPractitioners can be assured that functional and balance performances will not be impacted by wearing an ankle brace.

Enhancing indoor air quality and cardiopulmonary health in patients with asthma by photocatalytic oxidation and filters air cleaner

BackgroundAir purifiers can enhance indoor air quality and health outcomes, and studies have primarily focused on filters and particulate matter (PM) in households. Photocatalytic oxidation (PCO) is a promising technique for eliminating gaseous pollutants and bioaerosols. However, no field study was conducted in household. Therefore, this study evaluated the effects of the PCO and PCO + filters intervention on indoor air pollutants and cardiopulmonary endpoints in households. MethodsA randomized, double-blind crossover clinical trial was conducted. Indoor air pollutants, including PM, bioaerosols, and gaseous pollutants and cardiopulmonary endpoints including lung function, fractional exhaled nitric oxide (FeNO), respiratory symptoms, and blood pressure were assessed before and after intervention. FindingsThis was the first study to evaluate the effects of PCO and PCO + filters interventions on indoor air pollutants and cardiopulmonary health in households. Indoor total volatile organic compounds (TVOC) and sulfur dioxides (SO2) significantly reduced after PCO intervention, however, we also observed the significant reduction in percentage of predicted values of forced vital capacity (FVC%) and forced expiratory volume in 3 s (FEV3%) and increased in FeNO after 13 days of PCO intervention. The PCO + filters intervention significantly reduced the levels of indoor PM1, PM2.5, PM4, PM10, total suspended particulate matter, ultrafine particles, airborne bacteria, fungi, endotoxin, mites, TVOC, nitrogen dioxide, and SO2, and marginal reduction in carbon monoxide. However, indoor carbon dioxide significantly increased after PCO/PCO + filters intervention. As for cardiopulmonary health, FVC%, and FEV1 % marginally increased 7 days after the PCO + filters intervention.

Efficacy and Safety of Sodium Oxybate in Isolated Focal Laryngeal Dystonia: A Phase IIb Double-Blind Placebo-Controlled Cross-Over Randomized Clinical Trial.

To examine the efficacy and safety of sodium oxybate versus placebo in a phase IIb randomized double-blind placebo-controlled 2-period cross-over clinical trial in patients with isolated laryngeal dystonia (LD). The study was conducted from January 2018 to December 2021, pausing during the COVID-19pandemic, at Massachusetts Eye and Ear in 106 patients with alcohol-responsive (EtOH+) and alcohol-non-responsive (EtOH-) LD (53 to receive 1.5g of sodium oxybate first, 53 to receive matching placebo first). The primary outcome was a change from baseline in LD symptom severity 40 minutes after drug intake. Safety was based on vital signs, cognitive function, suicidality, daytime sleepiness, and adverse events. Patients, investigators, and outcome assessors were masked to study procedures. Compared to baseline, EtOH+ but not EtOH- patients had a statistically significant improvement in LD symptoms following sodium oxybate versus placebo (EtOH+: 98.75% confidence interval [CI] = 0.6-26.9; p = 0.008; EtOH-: 98.75% CI = -6.2 to 18.7; p = 0.42). Statistically significant minimum drug efficacy in EtOH+ patients was found at ≥16% symptom improvement (OR = 2.09; 98.75% CI = 0.75-5.80; p = 0.036), with an average of 40.81% benefits (98.75% CI = 34.7-48.6). Drug efficacy waned by 300 minutes after intake without a rebound. No changes were found in cognitive function, suicidality, or vital signs. Common adverse events included mild dizziness, nausea, and daytime sleepiness. Sodium oxybate showed clinically meaningful improvement of symptoms in EtOH+ LD patients, with acceptable tolerability. Sodium oxybate offers the first pathophysiologically relevant oral treatment for laryngeal dystonia. ANN NEUROL 2024.

Cognitive Benefits of Reducing Indoor Particulate Matter Exposure During Sleep: New Evidence from a Randomized, Double-blind Crossover Trial.

There is increasing evidence that particulate matter (PM) pollution may adversely impact cognition. Considering that sleep is critical for cognitive health and occupies about one-third of human life, understanding the cognitive effects of indoor PM exposure during sleep and the potential cognitive benefits of reducing such exposure is crucial, yet currently unknown. This randomized, double-blind crossover intervention trial was conducted among 80 college students with real and sham PM filtration in their dormitories. Real-time indoor PM levels and nocturnal sleep parameters were monitored, followed by quantification of serum neurotransmitter metabolites and cognitive assessments in the mornings. We found that PM exposure during sleep, particularly PM1 and PM2.5, affected immediate and delayed memory, executive function, and global cognition. Reducing PM exposure during sleep resulted in improvements in multiple cognitive domains, with a 0.21 (95% CI: 0.05, 0.36) increase in global cognitive z-score, in which increased sleep oxygen saturation (SpO2) and alterations in dopamine metabolism and histidine metabolism played important roles. Notably, even when indoor PM2.5 levels were below the WHO air quality guidelines, further reducing PM exposure could still improve sleep SpO2 and neurotransmitter metabolism. This study provides a promising strategy to mitigate indoor PM-induced cognitive impairment.

Effect of Lingual Nerve Block and Localised Somatosensory Abnormalities in Patients With Burning Mouth Syndrome-A Randomised Crossover Double-Blind Trial.

To investigate the effect of a lingual nerve block on spontaneous pain in patients with burning mouth syndrome (BMS) and to estimate associated somatosensory abnormalities by quantitative sensory testing (QST). A standardised QST battery including cold detection threshold (CDT), warmth detection threshold (WDT), thermal sensory limen (TSL), paradoxical heat sensation (PHS), cold pain threshold (CPT), heat pain threshold (HPT), mechanical pain threshold (MPT), wind-up ratio (WUR) and pressure pain threshold (PPT) was performed at the oral mucosa of the most painful site and intraoral control site in 20 BMS patients, and at the tongue and cheek mucosa in 22 age- and gender-matched healthy controls. The effect of a lingual nerve block on spontaneous burning pain reported by the BMS patients on a 0-10 cm visual analogue scale (VAS) was investigated in a randomised double-blind crossover design using (1 mL) lidocaine (lido) or saline (sal) with an interval of 1 week. The BMS patients were grouped into 'central' and 'peripheral' mechanisms based on the effect of the lingual nerve injections. For each BMS patient, Z-scores and Loss/Gain scores were computed. Differences among groups and sites were analysed using a two-way ANOVA. Differences within group were assessed by paired t-test. The 20 BMS patients were characterised on the basis of VAS changes (ΔLido-ΔSal) as a peripheral BMS subgroup (n = 9) with pain relief more than 1 cm on the VAS and a central BMS subgroup (n = 11) with pain relief less than 1 cm. BMS patients (n = 20) had lower sensitivity to thermal stimuli (i.e., CDT, WDT, TSL, CPT, HPT and PPT) and higher sensitivity to mechanical stimuli (i.e., PPT) compared with controls (p ≤ 0.007). Based on Loss/Gain coding, L1G0 (loss of thermal somatosensory function with no somatosensory gain, 55.0%) was the most frequent coding in the BMS group, which was higher than 11.4% in the control group (p < 0.001). Surprisingly, there was no significant difference between the peripheral and central BMS subgroups with regard to the Z-scores of any of the nine QST parameters (p > 0.097). The results of the lingual nerve blocks demonstrated two distinct phenotypes with either peripheral or central mechanisms but no direct impact on somatosensory function. Overall, somatosensory function in BMS patients seems abnormal in the painful areas compared to matched controls with a conspicuous loss of thermosensory function.

The Effect of Pre-Exercise Caffeine and Glucose Ingestion on Endurance Capacity in Hypoxia: A Double-Blind Crossover Trial.

The impact of caffeine and glucose supplementation in a hypoxic environment on endurance exercise performance remains inconclusive. The current study examined the effect of pre-exercise carbohydrate and caffeine supplementation on endurance exercise performance in an acute hypoxic environment. Eight healthy active young males participated in this double-blind, within-subjects crossover study. Participants ingested the test drink 60 min before exercising at 50% Wmax for 90 min on a cycle ergometer (fatiguing preload); there followed an endurance performance test at 85% Wmax until exhaustion in a hypoxic chamber (~15%O2). Participants completed four experimental trials in a randomized order: caffeine (6 mg·kg-1; Caff), glucose (1 g·kg-1; CHO), caffeine (6 mg·kg-1) + glucose (1 g·kg-1; Caff-CHO), and taste- and color-matched placebo with no caffeine or CHO (PLA). Blood samples were collected during fasting, pre-exercise, every 30 min throughout the exercise, and immediately after exhaustion. The caffeine and glucose trials significantly enhanced endurance capacity in hypoxic conditions by Caff, 44% (68.8-31.5%, 95% confidence interval), CHO, 31% (44.7-15.6%), and Caff-CHO, 46% (79.1-13.2%). Plasma-free fatty-acid and glycerol concentrations were higher in Caff and PLA than in CHO and Caff-CHO (p < 0.05). The estimated rate of fat oxidation was higher in Caff and PLA than in CHO and Caff-CHO (p < 0.05). There were no significant differences in ratings of perceived exertion between trials. In conclusion, the ingestion of caffeine, glucose, or caffeine + glucose one hour before exercising in hypoxic conditions significantly improved 85% Wmax endurance performance after prolonged exercise.

Safety, tolerability, and efficacy outcomes of the Investigation of Levetiracetam in Alzheimer's disease (ILiAD)study: a pilot, double-blind placebo-controlled crossover trial.

To assess whether the antiseizure medication levetiracetam may improve cognition in individuals with Alzheimer's disease who have not previously experienced a seizure. We performed a randomized, double-blind, placebo-controlled crossover pilot study in individuals with mild-to-moderate Alzheimer's disease. Electroencephalography was performed at baseline and those with active epileptiform discharges were excluded. Eligible participants were randomized to placebo for 12 weeks or an active arm of oral levetiracetam (4 weeks up-titration to levetiracetam 500 mg twice daily, 4 weeks maintained on this dose followed by 4 weeks down-titration to nil). Participants then crossed over to the other arm. The primary outcome was change in cognitive function assessed by the Oxford Memory Task, a task sensitive to hippocampal memory binding. Secondary outcomes included tolerability, other neuropsychological scales, and general questionnaires. Recruitment numbers were severely limited owing to restrictions from the COVID-19 pandemic at the time of the study. Eight participants completed both arms of the study (mean age 68.4 years [SD = 9.2]; 5 females [62.5%]). No participants withdrew from the study and there was no significant difference between reported side effects in the active levetiracetam or placebo arm. Measures of mood and quality of life were also not significantly different between the two arms based on participant or carer reports. In limited data analysis, there was no statistically significant difference between participants in the active levetiracetam and placebo arm on the memory task. This pilot study demonstrates that levetiracetam was well tolerated in individuals with Alzheimer's disease who do not have a history of seizures and has no detrimental effect on mood or quality of life. Larger studies are needed to assess whether levetiracetam may have a positive effect on cognitive function in subsets of individuals with Alzheimer's disease. Abnormal electrical activity within the brain, such as is seen in seizures, might contribute to memory problems in people with dementia. We completed a clinical trial to see if an antiseizure medication, levetiracetam, could help with memory difficulties in people with Alzheimer's disease (the most common cause of dementia). In this pilot study, we could not prove whether levetiracetam helped memory function. We did show that the drug is safe and well tolerated in people with dementia who have not had a seizure. This work, therefore, offers a platform for future research exploring antiseizure medications in people with dementia.

Acute ingestion of caffeinated chewing gum reduces fatigue index and improves 400-meter performance in trained sprinters: a double-blind crossover trial.

This study investigated the effects of caffeinated chewing gum on fatigue index and 400-meter performance in trained sprinters. Nineteen participants (age: 20.9 ± 1.0 years; height: 175.6 ± 4.9 cm; mass: 66.5 ± 5.6 kg; training age: 7.9 ± 1.0 years) were randomly assigned to either a caffeine trial (CAF) or a placebo trial (PL) using a double-blind, randomized crossover design. The participants in the CAF trial chewed a gum containing 3 mg/kg of caffeine for a period of 10 minutes, while those in the PL trial chewed a gum containing a placebo with no caffeine. Following a 15-minute period of rest, the fatigue index was tested by six maximal 35-meter sprints with a 10-second rest between efforts. After this, at least 30 minutes of rest was permitted, during which time the participants engaged in brief warm-up activities prior to the commencement of the 400-meter sprint test. Saliva samples were collected before chewing gum, before the fatigue test and before 400-meters sprinting. The fatigue index was significantly lower in the CAF trial compared to the PL trial (CAF: 8.1 ± 2.5%; PL: 9.6 ± 4.8%; p = 0.046, Cohen's d = 039). The CAF trial demonstrated significantly lower sprint time for the 300-400 meter segment (CAF: 14.73 ± 1.35 seconds; PL: 15.23 ± 1.30 seconds; p = 0.019, Cohen's d = 0.37) and total sprint time compared to the PL trial (CAF: 53.87 ± 2.88 seconds; PL: 54.68 ± 3.37 seconds; p = 0.003, Cohen's d = 0.27). Saliva caffeine and α-amylase concentration were significantly higher in the CAF trial compared to the PL trial (p < 0.05). The present study demonstrated that caffeine gum supplementation prior to exercise significantly reduced the fatigue index and increased the capacity to maintain speed, particularly in the final 300 to 400 meters, as well as enhancing 400-meter sprint performance.

Rehabilitation technique of proprioceptive neuromuscular facilitation applied to volleyball vertical jump: A randomized double blinded cross-over clinical trial

Objectivecompare the acute effect of lower limb stretching exercises with proprioceptive neuromuscular facilitation (PNF) on the antagonist and agonist muscle groups in the execution of a vertical jump (VJ). Methoda randomized, double-blind, crossover clinical trial was conducted involving 30 male volleyball athletes. Group A engaged in PNF on the antagonist muscles, while Group B applied the same method to the agonist muscles. Following a 48-h washout period, the interventions were swapped between the respective groups. Both groups underwent assessments averaging three countermovement vertical jumps (CVJ) with hands on hips and three VJ with arms free. Measurement was taken using the Encoder – Ergonauta I, with over 1500 jumps recorded. The participants were evaluated for their level of flexibility and VJ performance using the Jump Sigma Index application. Resultsan acute decrease in average performance was identified, amounting to 3.86 % for the CMJ with hands on hips and 3.06% for the CVJ with free hands, following PNF in the agonists. Conclusionthere was no statistical difference between the means before and after the intervention when PNF was applied to the antagonistic hamstring muscles. The CVJ modalities with hands on hips and with free hands presented statistically similar indices. The study suggests that there is no impediment to the implementation of warm-up or training protocols that involve stretching in the antagonistic muscles. Further research will be relevant to better clarify the relationship between the effects of stretching on antagonistic muscle groups and to formalize future protocols.

Age-Related Effects of Olive Oil Polyphenol Ingestion on Oxidation of Low-Density Lipoprotein in Healthy Japanese Men: A Randomized Controlled Double-Blind Crossover Trial.

The function of olive oil polyphenols in suppressing the oxidation of low-density lipoprotein (LDL) is well-known in Europeans. However, it remains unclear whether olive oil polyphenols exert antioxidant effects in Japanese people. The objective of this study was to determine whether the ingestion of olive oil polyphenols suppresses LDL oxidation in the Japanese population and whether this effect depends on age. This randomized controlled double-blind crossover trial with a 2-week washout enrolled 80 healthy Japanese men aged 35-64 years. Participants ingested either 14 g of extra virgin olive oil containing 5.0 mg of olive oil polyphenols (test food) or 14 g of refined olive oil containing 0.3 mg of olive oil polyphenols (control food) for 3 weeks. The primary outcome was oxidized LDL (malondialdehyde-modified LDL; MDA-LDL). Subgroup analyses based on age (35-50 and 51-64 years) were also performed. In all of the participants (35-64 years), there were no significant differences in MDA-LDL between the control and test groups. However, in the 35-50 years subgroup, ingestion of olive oil polyphenols led to a significantly larger reduction in MDA-LDL as compared with the control group (p < 0.025). The significantly lower dietary total polyphenol intake of the 35-50 years subgroup compared to the 51-64 years subgroup suggests that the suppressive function of olive oil polyphenol intake on LDL oxidation in Japanese men is influenced by dietary habits and is more clearly demonstrated in the younger age population with a relatively low total polyphenol intake.

Effects of GSH on Alcohol Metabolism and Hangover Improvement in Humans: A Randomized Double-Blind Placebo-Controlled Crossover Clinical Trial.

The definition of alcohol hangovers refers to a combination of mental and physical side effects that occur after drinking. One of the ways that hangovers can be ameliorated is by promoting the rapid and effective elimination of acetaldehyde to alleviate the discomfort it causes. This study aimed to investigate the effects of GSH (yeast extract containing 50 mg of glutathione) on the hangover-relieving effect. A randomized double-blind placebo-controlled crossover clinical trial was conducted with 40 participants who reported experiencing hangover symptoms. Participants consumed alcohol at a rate of 0.78 g per kg body weight with 40% whiskey, adjusted according to their weight. Alcohol and acetaldehyde concentrations in serum were analyzed at 0, 0.25, 1, 2, 4, 6, and 15 h after alcohol consumption. In the GSH group, the serum alcohol concentration decreased, although this change was not statistically significant. The serum acetaldehyde concentration was significantly lower in the GSH group in comparison to the placebo group (at 0.25, 1, 4, and 6 h (p < 0.01) and at 0.5, 2, and 15 h (p < 0.001) after alcohol consumption). However, there was no significant difference between the two groups on questionnaires such as the Acute Hangover Scale and the Alcohol Hangover Severity Scale. Overall, we consider the discovery that GSH lowered acetaldehyde concentration, a crucial factor in alcohol metabolism, to be more considerable. Therefore, GSH administration effectively reduces acetaldehyde levels in serum. This result suggests that this effect may contribute to the relief of hangover symptoms.

Naturalistic psychedelic therapy: The role of relaxation and subjective drug effects in antidepressant response.

Psychedelic-assisted therapy (PAT) is permitted in Switzerland under its limited medical use program. Data from patients in this program represent a unique opportunity to analyze the real-world practice of PAT. This study compared the subjective effects of lysergic acid diethylamide (LSD) and psilocybin between patients undergoing PAT and healthy volunteers. For the patients, it also investigated the relationship between antidepressant effects and six measures of acute drug effects. We compared data on acute psychedelic drug effects between 28 PAT patients with data from 28 healthy participants who participated in a randomized, double-blind crossover trial. All participants received varying doses of psilocybin and LSD. Subjective effects were assessed on an hourly basis during the acute drug effects, and the Mystical Experience Questionnaire (MEQ) was completed retrospectively. For patients, depressive symptoms were assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS). Ratings of overall drug effect and mystical experience were similar across groups. Compared with healthy controls, patients reported lower ratings of ego dissolution. Patients showed a significant decrease in MADRS scores, and the greatest predictor of antidepressant outcome was relaxation during the PAT session. We did not observe a relationship between mystical-type experiences and antidepressant effects. Most patients experienced mild adverse effects which resolved within 48 h. PAT reduced depressive symptoms in this heterogeneous patient group. Patients may experience more challenging psychedelic effects and reduced ego dissolution. Hourly assessment of drug effects may predict clinical outcomes better than retrospectively assessed mystical experiences, and the impact of relaxation during PAT should be investigated further.

Effects of Caffeinated Chewing Gum on Ice Hockey Performance after Jet Lag Intervention: Double-Blind Crossover Trial.

The purpose of this study was to examine the impact of caffeinated chewing gum on the physical performance of elite ice hockey players after a jet lag intervention. Fourteen national-level (age: 25.2 ± 5.4; height: 176.5 ± 5.3; weight: 78.1 ± 13.4) ice hockey players were tested late at night after a full day awake schedule with jet lag. A randomised, double-blind experimental design was employed in which participants either chewed caffeinated gum (CAF) containing 3 mg/kg caffeine or a caffeine-free placebo gum (PLA) for 10 min prior to undertaking a series of on-ice and off-ice tests. The off-ice tests included grip force, the counter-movement jump (CMJ), and the squat jump (SJ). The on-ice tests included a 35 m sprint, the S-Shape agility test, and the Yo-Yo intermittent recovery test (Yo-Yo IR1 test). The CMJ height (CAF: 47.2 ± 4.4; PL: 45.9 ± 3.5; p = 0.035; Cohen's d = 0.32) and SJ height (CAF: 46.7 ± 4.1; PL: 44.9 ± 3.8; p = 0.047; Cohen's d = 0.44) were found to be significantly higher in the CAF than in the PL trial. However, there were no significant differences (p > 0.05) in grip force, as well as in the 35 m sprint, the S-Shape agility test, and the Yo-Yo IR1 test. The present study found that, following a jet lag intervention, although the consumption of caffeinated gum resulted in an increase in vertical jump height, it had no impact on performance in the ice tests. The results of this study may help coaches and athletes consider the need for caffeine supplementation when experiencing jet lag.

Laxative Properties of Microencapsulated Oleic Acid Delivered to the Distal Small Intestine in Patients with Constipation after Bariatric Surgery or Treatment with Glucagon-Like- Peptide 1 Analogues

BackgroundConstipation is prevalent after bariatric surgery and glucagon-like-peptide 1 (GLP-1) analogues. Increasing fat content in the distal small intestine and colon can enhance colonic peristalsis, potentially alleviating symptoms of constipation.AimWe investigated whether oleic acid can ameliorate constipation in patients undergoing bariatric surgery or receiving GLP-1 analogues.MethodologyFourteen adults with chronic constipation according to Rome IV criteria following bariatric surgery or GLP-1 analogues were on stable treatment for constipation for more than 4 weeks. This randomized double-blind crossover trial compared microcapsules containing 21.25 g of oleic acid delivered in the distal small intestine or the stomach. The primary outcome was changed in the number of bowel motions over 24 h. Exploratory endpoints included alterations in straining, diarrhoea, faecal leakage over 24 h and hunger, fullness, nausea and calorie intake for the 3 h after ingesting the microcapsules.FindingsReceiving oleic acid into the distal small intestine increased number of bowel movements per day (2.5 vs 1.1, p = 0.009) and caused softer stool consistency (p = 0.03). 9/14 of the control group passed motions and 13/14 of the intervention group passed motions in 24 h (p = 0.059). No significant differences were observed in straining (p = 0.65), rapid bowel movements (p = 0.08), accidental leakage (p = 0.32), hunger, fullness, nausea or food intake between the groups (all p > 0.05). There were no disparities in safety profile between groups.ConclusionMicrocapsules containing oleic acid delivered to the distal small intestine appear to be a safe and effective relief from chronic constipation in patients undergoing bariatric surgery and/or receiving GLP-1 analogues.Graphical

The Impact of Stimulation Parameters on Cardiovascular Outcomes in Chronic Stroke Patients Following Transcranial Direct Current Stimulation-A Pilot Controlled, Randomized, Double-Blind Crossover Trial.

Stroke survivors often experience autonomic nervous system (ANS) dysfunction. While Transcranial Direct Current Stimulation (tDCS) has been shown to modulate the ANS when applied to the left hemisphere, its effects on the right hemisphere remain unexplored. We aimed to compare the effects of tDCS applied to both the injured and the contralateral hemispheres on heart rate variability (HRV) and functional capacity in individuals post-stroke. Twenty individuals with cerebral hemisphere lesions (ten with right-hemisphere lesions and ten with left-hemisphere lesions) were randomized into four groups: anodal and sham tDCS on the left temporal cortex (T3) and anodal and sham tDCS on the right temporal cortex (T4). HRV was assessed before the intervention, after the six-minute walk test (6MWT), and following tDCS. HRV data were categorized into frequency ranges: low frequency (LF), high frequency (HF), and sympathovagal balance. The 6MWT (meters) was conducted both pre- and post-tDCS. In individuals with right-hemisphere lesions, a higher global LF value was observed (right side: 71.4 ± 16.8 nu vs. left side: 65.7 ± 17.3 nu; p = 0.008), as well as lower values of the HF component (right side: 29.5 ± 18.9 nu vs. left side: 34.0 ± 17.4 nu; p = 0.047), consequently exhibiting higher global values of the low/high-frequency ratio (right side: 3.9 ± 2.8 vs. left side: 2.9 ± 2.4). Regarding the stimulation site, tDCS over T3 led to a lower overall value of the low/high-frequency ratio (left hemisphere: 3.0 ± 2.2 vs. right hemisphere: 3.7 ± 2.9; p = 0.040) regardless of the lesion location. A significant increase in the distance covered in the 6MWT was observed for individuals with lesions in both hemispheres after tDCS at T3. Participants with right-hemisphere lesions exhibited superior global sympathetic autonomic nervous system activity. When the tDCS was applied on the left hemisphere, it maintained lower sympathovagal balance values and improved functional capacity regardless of the hemisphere affected by the stroke.

Cannabidiol for treatment of Irritability and Aggressive Behavior in Children and Adolescents with ASD: Background and Methods of the CAnnabidiol Study in Children with Autism Spectrum DisordEr (CASCADE) Study.

Autism spectrum disorder (ASD) is a neurodevelopmental disorder commonly associated with behavioral challenges. There are few evidence based pharmacological interventions available for the treatment of behavioral symptoms associated with ASD. Cannabidiol (CBD), the non-psychoactive component of cannabis, has potential neuroprotective, antiepileptic, anxiolytic, and antipsychotic effects and may be useful in treating the behavioral symptoms of ASD. We describe the research methods of a 27-week double-blind placebo-controlled cross-over trial of cannabidiol for the treatment of irritability and aggression associated with ASD, utilizing the irritability subscale of the Aberrant Behavior Checklist-2nd edition (ABC-2) as the primary outcome measure. Adverse effects and safety monitoring protocols are included. Several secondary and exploratory outcomes measures also include anxiety, communication, repetitive behaviors, attention, hyperactivity, autism family experience, and telehealth functional behavior assessment. There is a significant need for clinical research exploring alternative medications for the treatment of behavioral symptoms of ASD. Cannabidiol (CBD) is being studied for the management of irritability, aggression, and other problem behaviors associated with ASD.

H-coil repetitive transcranial magnetic stimulation does not improve executive function in patients with chronic peripheral neuropathic pain: a randomized sham-controlled crossover study.

Deep rTMS is an increasingly popular noninvasive brain stimulation technique which has shown promise for treating cognitive impairments. However, few studies have investigated the cognitive effects it could exert in patients with chronic peripheral neuropathic pain. Therefore, we aimed to assess the effects of deep rTMS on executive functioning in patients with peripheral neuropathic pain, in a randomized, double-blind crossover trial. In total, 17 patients were randomly assigned to receive both active and sham deep H-coil rTMS targeting the primary motor cortex. Each treatment period consisted of five daily rTMS sessions. Selected tests of executive functioning from the CANTAB test battery (paired associates learning, stop signal task, spatial working memory and multitasking test) were performed at baseline, and at 1 week and 3 weeks follow-ups. We did not find any significant interactions between time and treatment for the measures of executive functioning for the patient group, or for patients with reduced cognition compared to normative means. High-frequency deep H-coil rTMS targeting the hand area of the primary motor cortex and delivered over 5 consecutive days did not improve executive functioning in patients with chronic peripheral neuropathic pain. https://clinicaltrials.gov/, identifier NCT05488808.

Cognitive and Emotional Effect of a Multi-species Probiotic Containing Lactobacillus rhamnosus and Bifidobacterium lactis in Healthy Older Adults: A Double-Blind Randomized Placebo-Controlled Crossover Trial.

As the population ages, cognitive decline becomes more common. Strategies targeting the gut-brain axis using probiotics are emerging to achieve improvements in neuropsychiatric and neurological disorders. However, the beneficial role of probiotics on brain function in healthy older adults remains unclear. Our aim was to evaluate a multi-species probiotic formulation as a therapeutic approach to reduce emotional and cognitive decline associated with aging in healthy adults. A randomized double-blind placebo-controlled crossover trial was conducted. The study involved a 10-week intervention where participants consumed the assigned probiotic product daily, followed by a 4-week washout period before the second condition started. Cognitive function was assessed using the Mini-Mental State Examination (MMSE) and the Psychological Experiments Construction Language Test Battery. At the emotional level, the Beck Depression Inventory (BDI) and the State-Trait Anxiety Inventory (STAI) were used. Thirty-three participants, recruited between July 2020 and April 2022, ingested a multispecies probiotic (Lactobacillus rhamnosus and Bifidobacterium lactis). After the intervention, noticeable enhancements were observed in cognitive function (mean difference 1.90, 95% CI 1.09 to 2.70, p < 0.005), memory (mean difference 4.60, 95% CI 2.91 to 6.29, p < 0.005) by MMSE and digit task, and depressive symptoms (mean difference 4.09, 95% CI 1.70 to 6.48, p < 0.005) by BDI. Furthermore, there were significant improvements observed in planning and problem-solving skills, selective attention, cognitive flexibility, impulsivity, and inhibitory ability. Probiotics administration improved cognitive and emotional function in older adults. Limited research supports this, requiring more scientific evidence for probiotics as an effective therapy for cognitive decline. This study has been prospectively registered at ClinicalTrials.gov (NCT04828421; 2020/July/17).

Abstract 3009: Progressive Structured Simulation-based Surgical Training Program (PROCESS) - Open Vascular Surgery: Study Protocol For A Cross-over, Randomized, Double-blinded Clinical Trial.

Objective: Vascular surgery has been directed towards endovascular approaches; however, not all patients qualify for these procedures. Open vascular surgery (OVS) remains an alternative, demanding a steep learning curve. Exposure to these procedures has declined resulting in a lack of standardization in acquiring OVS skills. Simulation is a solution to this challenge. However, in OVS, there is scarce evidence for structured programs. The measurement of surgical skills is based on objectively assessable subjective tools; yet, they have limitations as evaluators may introduce inherent individual biases. We aim to compare the effectiveness of technical surgical competencies acquisition between a structured progressive simulation-based training program and isolated experience-based training in OVS. Methods: We will conduct a randomized double-blind crossover clinical trial. A control sequence and an intervention sequence of three subgroups with different exposure levels to the simulation program are proposed using 3D printed models. Group 1: open abdominal aortic repair (AAOR), Group 2: vascular anastomosis (VA) and AAOR, and Group 3: specific micro-surgical skills, VA and AAOR. Surgical residents of general, vascular, or cardiovascular surgery programs will be included. Sample size calculation resulted in 45 participants, 15 in each group. Double blinding will involve participants and external evaluators. Randomization will occur in block randomization and permuted block randomization. Results: We anticipated that the structured and progressive simulation-based training program objectively enhances technical surgical competencies. We expect to determine a significant difference in the acquisition of technical surgical competencies based on the progression through different modules within the program and validate the reliability of an assessment tool based on objective metrics for technical surgical competencies in OVS. Conclusion: We hope this initiative will impact the formation of future vascular surgeons, complementing experience-based training with simulation-based programs in OVS. Ensuring that the trainee obtains all the necessary tools to perform OVS and standardize an objective assessment evaluation method.