Function In Healthy Volunteers Research Articles

Investigating the impact of a novel copper chloride gel on endometrial growth and function in healthy volunteers

Research QuestionCopper is reported to stimulate production of Vascular Endothelial Growth Factor (VEGF), a cytokine known to enhance endometrial growth and embryo implantation. The aim of this study was to determine whether application of a micro-dose of copper chloride gel can increase endometrial production of VEGF, without compromising its function or producing embryo toxicity. DesignFollowing cell culture studies to estimate the optimal dose, ten healthy subjects received an initial uterine application of placebo gel, followed by copper chloride gel (37.5, 75, or 150-μM dose) in a later hormone replacement cycle. Endometrial biopsies (day 5.5 luteal) and pelvic ultrasound were performed during each cycle to evaluate endometrial function and growth. Uterine fluid was assessed for residual copper levels on the day of biopsy, and copper chloride gel underwent Mouse Embryos Assay (MEA) assessment for potential embryo-toxicity. ResultsThe copper gel significantly increased endometrial VEGF expression (q-PCR), while also increasing endometrial thickness by an average of 2.2 mm compared to matched control cycles. The copper gel didn't adversely impact endometrial morphology or maturation (histological dating and molecular receptivity testing), and MEA studies showed no evidence of embryo toxicity. Furthermore, uterine cavity flush samples mostly lacked copper, with only negligible amounts present in one sample. ConclusionApplying copper chloride gel to the uterine cavity up-regulated endometrial VEGF, while also significantly increasing endometrial thickness and volume. No adverse effects on the endometrium or embryos were observed. Copper chloride gels show promise for treating sub-optimal endometrial thickness if the results of this study are confirmed by larger RCTs.

Effects of corticotropin-releasing hormone on gastric electrical activity and sensorimotor function in healthy volunteers: a double-blinded crossover study.

Biopsychosocial factors are associated with disorders of gut-brain interaction (DGBI) and exacerbate gastrointestinal symptoms. The mechanisms underlying pathophysiological alterations of stress remain unclear. Corticotropin-releasing hormone (CRH) is a central regulator of the hormonal stress response and has diverse impact on different organ systems. The aim of the present study was to investigate the effects of peripheral CRH infusion on meal-related gastrointestinal symptoms, gastric electrical activity, and gastric sensorimotor function in healthy volunteers (HVs). In a randomized, double-blinded, placebo-controlled, crossover study, we evaluated the effects of CRH on gastric motility and sensitivity. HVs were randomized to receive either peripheral-administered CRH (100 µg bolus + 1 µg/kg/h) or placebo (saline), followed by at least a 7-day washout period and assignment to the opposite treatment. Tests encompassed saliva samples, gastric-emptying (GE) testing, body surface gastric mapping (BSGM, Gastric Alimetry; Alimetry) to assess gastric myoelectrical activity with real-time symptom profiling, and a gastric barostat study to assess gastric sensitivity to distention and accommodation. Twenty HVs [13 women, mean age 29.2 ± 5.3 yr, body mass index (BMI) 23.3 ± 3.8 kg/m2] completed GE tests, of which 18 also underwent BSGM measurements during the GE tests. The GE half-time decreased significantly after CRH exposure (65.2 ± 17.4 vs. 78.8 ± 24.5 min, P = 0.02) with significantly increased gastric amplitude [49.7 (34.7-55.6) vs. 31.7 (25.7-51.0) µV, P < 0.01], saliva cortisol levels, and postprandial symptom severity. Eleven HVs also underwent gastric barostat studies on a separate day. However, the thresholds for discomfort during isobaric distensions, gastric compliance, and accommodation did not differ between CRH and placebo.NEW & NOTEWORTHY In healthy volunteers, peripheral corticotropin-releasing hormone (CRH) infusion accelerates gastric-emptying rate and increases postprandial gastric response, accompanied by a rise in symptoms, but does not alter gastric sensitivity or meal-induced accommodation. These findings underscore a significant link between stress and dyspeptic symptoms, with CRH playing a pivotal role in mediating these effects.

Psychedelics and cognitive function: A systematic review

Introduction: With the progressive advancement of clinical and experimental trials aimed at investigating the pharmacotherapeutic potential of psychedelic substances, there is also the development of other conceptions of use, not only for the treatment of psychiatric disorders, but also for the improvement of emotional/cognitive functions. Objective: The present study is a systematic review of investigations aimed at evaluating the effects of psychedelics on cognitive functions in healthy volunteers. Methods: A search was performed in PubMed database, using the search terms “psychedelics and cognitive enhancement” and “psychedelics and cognitive performance”. Results and conclusions: Of the experimental studies analyzed, only forty-six (46) met the inclusion criteria. The results obtained showed that 3,4-methylenedioxy-methamphetamine (MDMA) was the most studied drug, with eighteen (18) articles. Fourteen (14) articles were published with psilocybin. Lysergic acid diethylamide (LSD) ranked third, with six (6) articles; other two (2) studies focused on investigating the beverage ayahuasca, and another (1) its psychoactive-containing molecule: dimethyltryptamine (DMT). Eight (8) studies investigated the effects of other psychedelic drugs, like S-ketamine, mescaline, 3,4-methylenedioxy-amphetamine (MDE), and ibogaine. Although there were no serious adverse effects resulting from the use of the investigated psychedelic drugs, rigorous assessment of the potential risks of long-term use and of the advantages of the continuous use of these drugs through neuropsychological assessments are still warranted.

Clinical evaluation of a novel gallotannin-enriched Galla Rhois extract (GRE) on vital cognitive functions in healthy volunteers: A randomized, double-blind, placebo-controlled study

Background: Oxidative damage has emerged as one of the significant factors in the onset of neurodegenerative disorders, primarily owing to a) higher usage of oxygen by brain cells and b) higher amounts of lipids in the neuronal membranes. Together, these have resulted in higher susceptibility of brain cells to ROS-induced lipid peroxidation, damage to other cellular macromolecules, including nucleic acids and proteins, and death of neurons by apoptosis, ferroptosis, and necrosis. The design of therapeutics to prevent oxidative damage-induced brain stroke or other irreversible injuries has remained a challenge owing to the continuous production of free radicals at the site of damage. In this respect, plant-derived tannins and tannic acid derivatives have exhibited promising results in scavenging free radicals and inhibiting lipid peroxidation.Objective: This investigation reports the effect of Ghala Rois extract (GRE), a methyl gallate enriched gall formed on the nutgall sumac tree, Rhus javanica L. (Anacardiaceae), on enhancing the cognitive function and overall well-being through a double-blind, placebo-controlled, randomized, parallel-group design study on 80 healthy adult volunteers over a period of six consecutive weeks.Results: Administration of GRE in the dosage of 750 mg/day p.o. (with an equal amount of corn starch as a placebo) after breakfast resulted in significant improvement in cognitive functions as assessed by HappyNeuroPro, a digital therapy tool, and the cognitive tools under Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MOCA) and Adult ADHD Self-Reported Scale (ASRSv1.1). Concomitantly, the GRE-treated subjects also scored significantly higher (p = 0.033) in the roles of Physical and Emotional Problems, Energy/Fatigue, Emotional well-being, and pain as evaluated by linearly independent pairwise comparisons among the estimated marginal means and computed using alpha = 0.05. In the Global Evaluation Questionnaire, over 77% of the treated subjects believed that the product increased their attention span, and helped their memory by 70%, and they also indicated their willingness to buy the commercially available GRE. Evaluation of the complete metabolic profile in the GRE-treated subjects significantly lowered the blood urea nitrogen (BUN) (11.98 mg/dL) as compared to placebo (13.27 mg/dL) (p = 0.011) as well as SGPT/ALT from 28.09 U/L (placebo) to 18.17 U/L (GRE-treated) (p&lt;0.001). However, the vital parameters, including heart rate and systolic/diastolic pressure, were not affected by the consumption of GRE extract.Conclusion: The study demonstrated that GRE could be used as an effective new phytotherapeutic for reversing oxidative damage-induced neuronal degeneration and improving cognitive health in these study individuals.Keywords: Galla Rhois extract (GRE); Rhus javanica L. (family Anacardiaceae); Cognitive functions; ADHD; Executive function; Verbal memory; Safety, Reactive Oxygen Species (ROS)

Correlation between the Capillary Blood Flow Characteristics and Endothelium Function in Healthy Volunteers and Patients Suffering from Coronary Heart Disease and Atrial Fibrillation: A Pilot Study.

Coronary heart disease (CHD) and atrial fibrillation (AF) pose significant health risks and require accurate diagnostic tools to assess the severity and progression of the diseases. Traditional diagnostic methods have limitations in providing detailed information about blood flow characteristics, particularly in the microcirculation. This study's objective was to examine and compare the microcirculation in both healthy volunteers and patient groups with CHD and AF. Furthermore, this study aimed to identify a relationship between blood microcirculation parameters and endothelial function. Digital capillaroscopy was employed to assess the microcirculation parameters, for example, such as capillary blood flow velocity, the size of red blood cell aggregates, and the number of aggregates per min and per running mm. The results indicate significant alterations in blood flow characteristics among patients with CHD and AF compared to healthy volunteers. For example, capillary blood flow velocity is statistically significantly decreased in the case of CHD and AF compared to the healthy volunteers (p < 0.001). Additionally, the correlation between the measured parameters is different for the studied groups of patients and healthy volunteers. These findings highlight the potential of digital capillaroscopy as a non-invasive tool for evaluating blood flow abnormalities (red blood cell aggregates and decreased capillary blood flow velocity) in cardiovascular diseases, aiding in early diagnosis and disease management.

5. Effects of Sustained D2 Receptors Blockade on Brain Structure and Function in Healthy Volunteers

5. Effects of Sustained D2 Receptors Blockade on Brain Structure and Function in Healthy Volunteers

Effects of Therapeutic Calf Massage on Cardiac Autonomic Function in Healthy Volunteers-a Pilot Study.

Calf massage is a therapeutic intervention that improves circulation and relieves us from pain & tightness. The calf massage also improves autonomic performance by modulating the vagal tone of the cardiovascular system. Therefore, the current study was intended to determine therapeutic calf massage on cardio autonomic activity in healthy subjects. To assess the immediate effect of a single 20-min session of calf massage on cardiac autonomic modulation through heart rate variability (HRV) measurement. In this study, 26 apparent healthy female participants aged between 18 and 25 years participated. Massage over the calf muscles on both legs for 20 min was performed, and resting cardiovascular parameters and HRV parameters were measured at baseline, immediately after the massage, and during the recovery periods (10 and 30 min after the massage). Data were analyzed using one-way ANOVA followed with post hoc analysis. Immediately after the massage intervention, heart rate (HR), systolic (SBP), and diastolic (DBP) blood pressure were decreased (p < .01), and the reduction was persisted at 10 min and 30 min of the recovery period (p < .01). In HRV parameters, the root mean square of successive differences (RMSSD) and high-frequency normalized unit (HF n.u.) increased, and low frequency (LF n.u.) decreased after the massage, and at the 10 and 30 min of the recovery period. The present study reports suggest a significant reduction in heart rate and blood pressure after the massage therapy. A drop in sympathetic tone and raise in parasympathetic tone can also attribute to the therapeutic effect.

Effect of Avena sativa (Oats) on cognitive function: A systematic review of randomized controlled trials.

The effect of polyphenol-rich diets or supplements on cognitive function remains a contentious topic. The objective of this study was to investigate the effects of Avena sativa (oat extracts) on cognitive function among healthy adults. A structured literature search was undertaken using PubMed, Web of Science, and Scopus from the database's establishment until March 17, 2022. Data on cognitive function, regarding accuracy and speed of performance, were gathered from randomized controlled trials (RCTs) that investigated the acute or chronic effects of Avena sativa in healthy subjects. The Cochrane Collaboration risk-of-bias tool was used to assess the quality of included studies. We included six RCTs, of which three were crossover designs, with a total of 287 individuals. Four studies investigated the acute effect of Avena sativa, while two investigated its chronic effect. Acute ingestion of Avena sativa appeared to positively influence the accuracy and speed of performance. While short-term chronic supplementation resulted in a significant improvement in cognitive function, long-term chronic supplementation did not. Overall, the evidence was of average quality. Acute supplementation with Avena sativa may improve cognitive function in healthy volunteers. Given the small number of trials included and the disparity of the intervention dose, the conclusions of this study should be interpreted with caution. More high-quality, long-term studies are warranted.

Associations between Endothelial Lipase, High-Density Lipoprotein, and Endothelial Function Differ in Healthy Volunteers and Metabolic Syndrome Patients.

Metabolic syndrome (MS) is characterized by endothelial- and high-density lipoprotein (HDL) dysfunction and increased endothelial lipase (EL) serum levels. We examined the associations between EL serum levels, HDL (serum levels, lipid content, and function), and endothelial function in healthy volunteers (HV) and MS patients. Flow-mediated dilation (FMD), nitroglycerin-mediated dilation (NMD), serum levels of HDL subclasses (measured by nuclear magnetic resonance (NMR) spectroscopy), and EL serum levels differed significantly between HV and MS patients. The serum levels of triglycerides in large HDL particles were significantly positively correlated with FMD and NMD in HV, but not in MS patients. Cholesterol (C) and phospholipid (PL) contents of large HDL particles, calculated as HDL1-C/HDL1-apoA-I and HDL1-PL/HDL1-apoA-I, respectively, were significantly negatively correlated with FMD in HV, but not in MS patients. Cholesterol efflux capacity and arylesterase activity of HDL, as well as EL, were correlated with neither FMD nor NMD. EL was significantly negatively correlated with HDL-PL/HDL-apoA-I in HV, but not in MS patients, and with serum levels of small dense HDL containing apolipoprotein A-II in MS patients, but not in HV. We conclude that MS modulates the association between HDL and endothelial function, as well as between EL and HDL. HDL cholesterol efflux capacity and arylesterase activity, as well as EL serum levels, are not associated with endothelial function in HV or MS patients.

Serotonin releasing agent fenfluramine improves executive function in healthy volunteers: an experimental medicine study

Serotonin releasing agent fenfluramine improves executive function in healthy volunteers: an experimental medicine study

Abstract 14636: The Effects of Celecoxib on Endothelial Function in Healthy Volunteers; A Double Blind, Placebo Controlled Randomised Trial

Introduction: Non-steroidal anti-inflammatory drugs (NSAIDs), which work by blocking cyclooxygenase (COX)-2 can increase cardiovascular risk by up to 30% after 2 weeks of use and in animal models augments thrombosis. However, the effect of NSAIDs and loss of COX-2 on endothelial function and blood flow remains incompletely understood. A plausible explanation is inhibition of COX-2 affects endothelial function by inhibiting prostacyclin and/or reducing endothelial nitric oxide synthase (eNOS) activity/expression. We hypothesised that COX-2 inhibition with celecoxib will impact on endothelial function. Methods: Healthy male volunteers aged between 18 to 40 were randomised 1:1 to receive either celecoxib (200 mg twice daily) or matching placebo for 7 days. The primary outcome was change (Δ) in endothelial function assessed using the EndoPAT device. Participants were given a home blood pressure machine and diary as a secondary outcome measure. Participants and outcome assessors were blinded to the intervention. Results: Between June 2021 and January 2022, 44 participants were randomised of which 40 participants completed the study (20 allocated to each arm) and were included in the final analysis. Baseline characteristics were similar between the groups. Compared to placebo, there was a significant increase in augmentation index (AI) following celecoxib use: Δ 6.2; (95% CI 0.05 to 12.4) p:0.048. There was no difference in log reactive hyperaemia index (LnRHI): Δ -0.092; (95% CI -0.31 to 0.12) p:0.39, systolic blood pressure: Δ -3.5; (95% CI -9.9 to 3) p:0.28, or diastolic blood pressure: Δ 4.7; (95% CI -1.8 to 11.1) p:0.15 (Figure) . Conclusion: In healthy male volunteers, 7 days of treatment with celecoxib significantly increased augmentation index which is a surrogate for vascular stiffness and an independent predictor of cardiovascular risk. Further clinical and mechanistic studies are required to elucidate how COX-2 inhibition impacts on augmentation index.

Equilibrium and Vestibular Safety of Modafinil in Healthy Volunteers.

BACKGROUND: Modafinil, as a wake-promoting agent, is commonly used to relieve fatigue during military operations. However, there is a lack of clarity regarding the effects of modafinil on the equilibrium and vestibular organs, especially when prescribing this drug to flight crewmembers. The objective of this study was to evaluate the equilibrium- and vestibular-related safety effects of modafinil.METHODS: In a randomized, double-blind, placebo-controlled, crossover study, 10 healthy male volunteers received a single 200-mg oral dose of modafinil or placebo. Equilibrium and vestibular functions were assessed 2 h after oral administration by the sensory organization test (SOT), adaptation test (ADT), and video head impulse test (v-HIT).RESULTS: There was no change in the equilibrium scores of the six SOT conditions or the composite scores between the modafinil and placebo groups. Statistically significant differences were not observed for the sway energy score (SES) in the toe-down test. In the toe-up test, the SES decreased by 16.7% in the modafinil group relative to the placebo group in trial 2, while the differences in other trials were not statistically significant. In the v-HIT, there was no significant difference in the gain of each semicircular canal between the two groups.DISCUSSION: A single 200-mg dose of modafinil did not cause any impairment to vestibular function, equilibrium ability, or adaptive balance response; in fact, modafinil might have a positive effect on adaptation function in healthy volunteers. These findings preliminarily suggest that there is no hidden risk of vestibular dysfunction among aviation employees using modafinil.Liu F, Zhang M, Chen T, Zhai L, Zhang Z, Xue J. Equilibrium and vestibular safety of modafinil in healthy volunteers. Aerosp Med Hum Perform. 2022; 93(6):487-492.

Effect of Acupuncture on Diaphragm Function in Healthy Volunteers: A Pilot Clinical Study

Introduction In western medicine, the diaphragm is the main inspiratory muscle. It is involved in the postural control of the trunk and contributes to balance performance. In traditional Chinese medicine (TCM), the diaphragm represents a gateway between the lower and upper parts of the body, and it regulates the descending and ascending functions of the whole organism. The aim of this study was to assess the effect of acupuncture on diaphragm function. Methods A proof-of-concept, prospective, controlled, pilot trial in healthy volunteers. Respiratory rate, inspired volume, diaphragm excursion, and thickening were measured during tidal and maximal breathing at baseline and after sham or real acupuncture. Acupuncture was performed on Yanglingquan (GB34), Tai Chong (LV3), Danzhong (CV17), Geshu (BL17), and Geguan (BL46). Results Ten participants were enrolled (6 males, weight 71 ± 12 kg, height 173 ± 9 cm, BMI 21 ± 1.3 kg/m2). During tidal breathing, tidal volume, diaphragm displacement, and end-expiratory diaphragm thickness did not change with sham or real acupuncture as compared to baseline; thickening ratio was 43.5 ± 16.6 vs. 31.3 ± 14.9 (sham) vs. 30.8 ± 15.3% (baseline), p=0.1066. During breaths at vital capacity, the acupuncture group, as compared to both baseline and sham acupuncture, had a trend toward a larger tidal volume (3840 ± 690 vs. 3110 ± 880 vs. 3230 ± 750 ml, p=0.1247) and showed a significantly higher thickening ratio (270.6 ± 136.4 vs. 172.4 ± 57.4 vs. 188.6 ± 41.7%, p=0.0414). Conclusions Acupuncture significantly influenced diaphragm function in healthy volunteers, improving its inspiratory thickening fraction during breaths at vital capacity, as compared to no or sham acupuncture.

Safety and Efficacy of a Novel Dietary Pyrroloquinoline Quinone Disodium Salt on Cognitive Functions in Healthy Volunteers: A Clinical Investigation

Cognitive dysfunctions are increasing alarmingly around the world, and researchers are exploring preventive measures for improving brain performance. Pyrroloquinoline quinone (PQQ), a naturally occurring coenzyme in foods, exhibits potent antioxidant activity, and improves diverse functions which includes mitochondrial activation, growth, repair, protection of nerve cells by increased expression of nerve growth factor (NGF) and NGF receptors; and suppression of fibril formation and aggregation of amyloid β. A randomized, double‐blind, placebo‐controlled, parallel‐group clinical investigation (RCT) was conducted over a period of 12 weeks of supplementation of PQQ disodium salt (mnemoPQQ®; p.o.; 21.5 mg/day) in 64 healthy Japanese male and female volunteers (age 40 ‐ &lt;80 Y) to determine the safety and efficacy on improved cognitive function and performance. In another independent study, mnemoPQQ® exhibited broad spectrum safety in a battery of toxicological assessments. No mutagenic potentials were observed. The efficacy of mnemoPQQ® on cognitive performance (memory, attention, judgment, and cognitive flexibility) was examined using Cognitrax as the primary outcome (endpoint), and forgetfulness questionnaire (DECO: Deterioration Cognitive Observee) and Mini‐Mental State Examination‐Japanese (MMSE‐J) as the secondary outcomes (endpoints). A total of 58 subjects (Placebo group = 31; Age = 70.91 ± 3.06 Y, and mnemoPQQ® group = 27; Age = 72.10 ± 3.77 Y) completed the study over a period of 12 weeks. Significant improvements were observed on the Cognitrax’s cognitive function domain score on “composite memory”, “verbal memory”, “reaction time”, “complex attention”, “cognitive flexibility”, “executive function”, and “motor speed” in the mnemoPQQ® group as compared to the placebo group. The DECO index and the MMSE‐J score were also significantly improved in the mnemoPQQ® group. No adverse events were reported. This investigation demonstrates that supplementation of mnemoPQQ® is safe and efficacious in improving memory, attention, judgment, and cognitive function, in middle‐aged to elderly population.

Efficacy and Safety of Dietary Undenatured Type II Collagen on Joint and Motor Function in Healthy Volunteers: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study

Objective: Prevalence of osteoarthritis (OA) is increasing alarmingly worldwide. Slowing down the progression of OA and diverse locomotive organ disorders is gaining interest in improving the quality of life (QOL) and extending healthy life-span. In a pilot study, intake of a small amount of undenatured type II collagen exhibited suppression of damage to the articular cartilage via oral immune tolerance. It also demonstrated improvement of knee and joint flexibility and mobility with continued intake of undenatured type II collagen (NEXT-II®) derived from chicken sternum cartilage. This randomized, double-blind, placebo-controlled, parallel-group clinical investigation (RCT) evaluated the efficacy and safety of 12 weeks of regular intake of NEXT-II® on joint and motor function in healthy Japanese male and female participants (aged 20 to <75 years). Method: Sixty-four participants were randomized to receive either NEXT-II® (undenatured type II collagen 3.2 mg/d) or placebo over a period of 12 consecutive weeks. Efficacy on joint and motor functions were evaluated measuring knee passive range of motion as the primary outcome; the Japan Knee Osteoarthritis Measure (JKOM), Visual Analog Scale (VAS) for knee discomfort, and motor functions (10-meter walking and stair-climbing test) as the secondary outcomes; and Japan Low back pain Evaluation Questionnaire (JLEQ) and VAS for lower back discomfort as the exploratory outcomes. Results: Fifty-eight participants (placebo = 28; NEXT-II® group = 30) completed the study. In the assessment of knee passive range of motion, significant improvements in “flexion” and “flexible angle (range)” were observed in the NEXT-II® group at 4, 8, and 12 weeks of treatment. NEXT-II® induced significant improvements in JKOM, VAS for knee and lower back discomfort, 10-meter walking test, stair-climbing test, and JLEQ. Conclusions: Results demonstrate that undenatured type II collagen is safe and efficacious in improving knee flexibility and mobility, reducing knee and lower back pain, and enhancing motor function.

Effect of Bhramari Pranayama Practice on Cognitive Functions in Healthy Volunteers

Bhramari Pranayama (Humming bee breath) is one of the common slow pranayama practices, which involvesinhaling through both nostrils and while exhaling produce sound of humming bee. Practicing pranayama reducesthe effects of stress and strain on various systems by increasing the vagal tone. With the ongoing COVID-19pandemic, there are heightened feelings of stress, anxiety and depression and pranayama can be an effective wayto improve our mental and emotional well-being. This study has been chosen to assess the effect of Bhramaripranayama on cognitive functions and to compare the immediate and training effects of Bhramari pranayama inthe study group. An observational study was conducted among 110 students in a medical college aged between18-22 years for a period of 2 months. The participants were instructed to do 9 rounds of Bhramari Pranayama afterwhich the immediate effect of the Pranayama and 3 weeks of Pranayama practice on cognitive functions wasassessed. After training of Bhramari Pranayama for 3 weeks, a statistically significant improvement was observed.The study shows the possibility that Bhramari Pranayama has a beneficial effect on HRV in medical students, asthe autonomic balance shifts towards the improvement of parasympathetic tone. The study also showed betterattention, concentration and improved cognitive functions immediately after performing Bhramari pranayamawhich might be due to increased alertness and calmness.

Comprehensive investigations revealed consistent pathophysiological alterations after vaccination with COVID-19 vaccines

Large-scale COVID-19 vaccinations are currently underway in many countries in response to the COVID-19 pandemic. Here, we report, besides generation of neutralizing antibodies, consistent alterations in hemoglobin A1c, serum sodium and potassium levels, coagulation profiles, and renal functions in healthy volunteers after vaccination with an inactivated SARS-CoV-2 vaccine. Similar changes had also been reported in COVID-19 patients, suggesting that vaccination mimicked an infection. Single-cell mRNA sequencing (scRNA-seq) of peripheral blood mononuclear cells (PBMCs) before and 28 days after the first inoculation also revealed consistent alterations in gene expression of many different immune cell types. Reduction of CD8+ T cells and increase in classic monocyte contents were exemplary. Moreover, scRNA-seq revealed increased NF-κB signaling and reduced type I interferon responses, which were confirmed by biological assays and also had been reported to occur after SARS-CoV-2 infection with aggravating symptoms. Altogether, our study recommends additional caution when vaccinating people with pre-existing clinical conditions, including diabetes, electrolyte imbalances, renal dysfunction, and coagulation disorders.

Acute effects of consumption of low-caffeine energy drinks on endothelial functions in healthy volunteers

Energy drink consumption is increasing among the population, especially adolescents and young adults. The health effects of energy drinks are unknown. In this study, we investigate the effects of low caffeine energy drinks on endothelial functions assessed by flow-mediated dilation (FMD) of the brachial artery. Thirty healthy volunteers (15 men, 15 women) aged 19 to 46 years participated in the study. Flow-mediated dilation measurements of the brachial artery were performed and recorded per protocol. The volunteers were asked to drink 355 mL of energy drink containing 53.25 mg of caffeine after baseline measurements, and all measurements were repeated 60 minutes later. Baseline and post-energy drink values were compared. Systolic blood pressure (p=0.592), diastolic blood pressure (p=0.714), and heart rate values (p=0.056) were similar before and after the consumption of energy drinks. Preocclusion arterial diameters (p=0.236) and blood velocities (p=0.447) did not change after energy drink consumption. FMD levels were 9.2%±4.6% and 8.1%±4.7%, respectively, before and after energy drink consumption (p=0.176). Women had a 3% increase in preocclusion arterial diameters after energy drink consumption, whereas men had a 2.6% decrease (p=0.026) Conclusion: Low caffeine energy drinks containing 53.25 mg of caffeine/355 mL can did not have any influence on blood pressure, heart rate, or endothelial functions in healthy volunteers.

A Randomized, Double-Blind Comparison Study of Royal Jelly to Augment Vascular Endothelial Function in Healthy Volunteers.

Aims: Royal jelly, a creamy substance secreted by honeybees, has been reported to have beneficial effects against dyslipidemia and metabolic syndrome. However, the effects of royal jelly on atherogenesis remain unknown. Hence, we prospectively evaluated whether royal jelly augments vascular endothelial function, which can reflect early atherogenesis, in healthy volunteers. Methods: This was a single-center, double-blind, 1:1 randomized placebo-controlled study conducted from October 2018 to December 2019. A total of 100 healthy volunteers were randomly assigned to receive either royal jelly 690 mg or placebo daily for 4 weeks. The primary endpoint was augmentation in vascular endothelial function as assessed using the change in the reactive hyperemia peripheral arterial tonometry index (RH-PAT) index, and the secondary endpoints were the changes in liver function and lipid profiles between baseline and 4 weeks after enrollment. Results: The mean age of the participants was 35.0±9.3 years in the placebo group and 36.1±9.1 years in the royal jelly groups; 45% and 50% of the placebo and the royal jelly groups, respectively, were male. The percentage relative change in the RH-PAT index was significantly higher in the royal jelly group than in the placebo group (21.4%±53.1% vs. 0.05%±40.9%,P=0.037). The percentage relative changes in alanine aminotransferase and γ-glutamyl transpeptidase were significantly lower in the royal jelly group than in the placebo group (alanine aminotransferase: −6.06%±22.2% vs. 11.6%±46.5%,P=0.02; γ-glutamyl transpeptidase: −3.45%±17.8% vs. 4.62%±19.4%,P=0.045). Lipid profiles were not significantly different between the two groups. Conclusions: Royal jelly might have antiatherogenic property by improving vascular endothelial function. It also augmented liver functions in healthy volunteers.

Effects of different high-flow nasal cannula flow rates on swallowing function

BackgroundHigh-flow nasal cannula therapy is used as a noninvasive treatment for people with acute respiratory disease. The aim of this study was to assess the impact of high-flow nasal cannula different flow rates on different characteristics of swallowing in healthy volunteers. MethodsA prospective cohort study where healthy adult volunteers were subject to high-flow nasal cannula at different flow rates (0, 10, 20, 30, 40, and 50 L/min, in random order). The 30-mL water swallow test, repetitive saliva swallowing test, and 0-100 mm visual analog scale assessed aspiration, swallow frequency and effort, respectively. FindingsThirty subjects (mean age 30 years) were enrolled. Nine subjects (30.0%) choked at 10, 40 and 50 L/min during the 30-mL water swallow test (p < 0.05). Swallowing effort was increased during flow rates ≥20 compared to 10 L/min (p < 0.05). Flow rates ≥20 L/min resulted in lower number of swallows during the repetitive saliva swallowing test compared to 0 and 10 L/min (p < 0.05). InterpretationHigh-flow nasal cannula flow rates above 40 L/min associated with choking (increased risk of aspiration), and was associated with decreased swallowing function in healthy volunteers. It may be important to assess swallowing function in patients with various clinical conditions and treated with high-flow nasal cannula, especially those at risk of aspiration pneumonia.