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In-Press Preview
PMC9843052
01/17/2023
Electronic publication
PMC9843052
Flow diagram of Study 250-201.
In Part 1, 3 patients, i.e., 9001, 9002, and 9003, were recruited and treated with escalating doses of 30, 100, and 300 mg tralesinidase alfa as described in Results. These 3 patients were eventually recruited to Part 2 of the study and treated for an additional 48 weeks. In addition, 19 patients, i.e., patients 9004–9...
PMC9843052
Drug exposure in plasma and CSF and anti-drug antibody response in serum and CSF.
(
PMC9843052
A 300 mg dose of tralesinidase alfa administered weekly i.c.v. normalizes total HS and HS-NRE levels in the CSF and plasma.
In Study 250-201 Part 1, three patients, i.e., 9001, 9002, and 9003, were treated with 30, 100, or 300 mg tralesinidase alfa weekly. Total HS (
PMC9843052
Changes in liver, spleen, cortical gray matter, and cerebellum gray matter volumes over the course of Study 250-201 Part 2.
LIVER
Liver (
PMC9843052
Correlation analyses of cognitive AEq scores, plasma drug exposure, plasma HS-NRE concentrations, and CGMVs over 48 weeks of tralesinidase alfa treatment.
(
PMC9843052
CSF and plasma drug exposure in patients given a single i.c.v. dose of 30, 100, or 300 mg tralesinidase alfa
PMC9843052
Characteristics of participants (
PMC9843052
Background
Resistance training adaptively increases muscle strength and mass, contributing to athletic performance and health promotion. Dietary intervention with natural foods provides nutrients that help accelerate muscle adaptation to training. Matcha green tea contains several bioactive factors such as antioxidants, amino aci...
PMC10320999
Methods
Healthy, untrained men were randomized into placebo and matcha groups. Participants consumed either a matcha beverage containing 1.5 g of matcha green tea powder or a placebo beverage twice a day and engaged in resistance training programs for 8 (trial 1) or 12 weeks (trial 2).
PMC10320999
Results
fatigue
In trial 1, maximum leg strength after training tended to increase more in the matcha group than that in the placebo group. In the matcha group, subjective fatigue after exercise at 1 week of training was lower than that in the placebo group. Gut microbe analysis showed that the abundance of five genera changed after m...
PMC10320999
Conclusion
fatigue
Daily intake of matcha green tea beverages may help in muscle adaptation to training, with modulations in stress and fatigue responses and microbiota composition.
PMC10320999
Supplementary Information
The online version contains supplementary material available at 10.1186/s12937-023-00859-4.
PMC10320999
Keywords
PMC10320999
Background
sarcopenia, muscle loss
SARCOPENIA
Skeletal muscles support physical activity and act as a major metabolic organ. In athletics, increased muscle strength and mass are important factors that improve performance. Age-related muscle loss and decreased strength, referred to as sarcopenia, have been recognized as major risk factors and may necessitate nursin...
PMC10320999
Methods
PMC10320999
Participants
muscle mass
CHRONIC DISEASES
Thirty-six young and healthy men participated in this study, which was approved by the ethics committee of Kyoto Prefectural University (No. 2017–146). All participants provided written informed consent. None of the participants suffered from current (at the time of the study) or prior chronic diseases or had a history...
PMC10320999
Experimental design
This study involved two randomized placebo-controlled trials (Fig. Experiment protocolDuring the trial period, the participants of both groups consumed beverages twice a day. The matcha group consumed a beverage containing 1.5 g matcha green tea powder [contents/cup; 0.06 g water, 0.4 g protein, 0.2 g fat, 4.4 g carboh...
PMC10320999
Resistance exercise training
The training program consisted of eight resistance exercises: chest press, fly, back extension, seated rowing, leg press, leg extension, leg curl, and sit-up, performed using a combined exercise machine (Senoh Co., Ltd., Chiba, Japan). The participants performed 3 sets of 10 repetitions at a 10-repetition maximum (RM)....
PMC10320999
Indirect metabolic performance
The participants were instructed to refrain from intense physical activities, eating, and drinking, except for water, from 22:00 until breakfast in the morning. In addition, they were requested to eat 200 g of steamed rice (energy, 312 kcal; protein, 5.0 g; fat, 0.6 g; and carbohydrate, 74.2 g) without caffeine and alc...
PMC10320999
Blood parameters
BLOOD
The participants were instructed to refrain from intense physical activity and fast from 22:00 h on the day before blood sample collection. On the day of blood sampling, each participant ate 200 g of steamed rice and rested for 1 h. Blood samples were collected before and after resistance exercise (8 exercises, 3 sets ...
PMC10320999
Subjective fatigue
fatigue
The degree of subjective fatigue before exercise (at rest) was measured using a visual analog scale. The participants were asked to indicate their degree of subjective fatigue on a 100-mm horizontal line, with the left end (0 mm) indicating “no fatigue” and the right end (100 mm) indicating “maximum fatigue.”
PMC10320999
Analysis of fecal microbiota
Brushes and sheets for stool collection were distributed to the participants, and stool samples were collected before, at week 4, and at week 8 of the intervention. Stool samples were refrigerated, and bacterial DNA was extracted within 3 weeks after collection. Metagenomic analyses of 16S rRNA of the extracted DNA sam...
PMC10320999
Saliva parameters
STERILE
To avoid the effect of the circadian rhythm, saliva was collected at the same time of day before and after the intervention, using a saliva collection kit (Salivette, Sarstedt, Germany) consisting of a centrifuge tube and sterile cotton. After rinsing the mouth with distilled water for 30 s, each participant, wearing r...
PMC10320999
Visual function
ocular motor skills, OMS
EYE
Two methods were used to evaluate the participants' ability to visually discern a moving object. Forward and backward kinetic visual acuity (KVA) was measured using a dynamic vision meter (AS-4; Kowa Co., Ltd., Tokyo, Japan). Lateral dynamic visual acuity (DVA) and ocular motor skills (OMS) were evaluated on a computer...
PMC10320999
Dietary assessment
A dietary assessment was conducted to calculate nutrient intake before trial commencement. All participants were permitted to eat freely, and their food intake was recorded for 3 days using a food diary and camera. Thereafter, a dietitian reviewed the recorded data to follow up and estimate participants' nutrient intak...
PMC10320999
Statistical analyses
All data are reported as mean ± standard deviation. A two-way analysis of variance (ANOVA) was conducted to assess the significance of the interaction between drink intervention (group) and time. Post hoc analyses were conducted using Bonferroni’s test to compare significant interactions following ANOVA. An intra-group...
PMC10320999
Results
PMC10320999
Blood and fatigue parameters during the 8-week intervention
fatigue
BLOOD
The concentration of serum carbonylated proteins and creatine kinase activity neither showed significant interactions nor training-induced changes (Fig. Blood and subjective fatigue parameters in trial 1. Serum carbonylated protein concentration (No differences in resting oxygen consumption, respiratory quotient, carbo...
PMC10320999
Gut microbiota during the 8-week intervention
The Chao1 and Shannon indices, which indicate the alpha diversity of gut bacteria, were not altered by the intervention within or between groups. However, the abundance of five genera changed significantly after the intervention. The abundance of Abundance of gut microbiota genera in trial 1. Proportion of the genera
PMC10320999
Body composition, stress-related parameters, and visual function during the 12-week intervention
muscle hypertrophy
Generally, the adaptation of skeletal muscles to resistance training results in an initial increase in muscle strength, followed by muscle hypertrophy with an extended training period. Therefore, we conducted trial 2 with an intervention period of 12 weeks. Stress-related parameters in saliva and visual ability were al...
PMC10320999
Discussion
muscle mass gain, fatigue
OXIDATIVE STRESS
In this study, we investigated the effects of matcha green tea consumption on adaptation to resistance training in young men. After the 8-week intervention (trial 1), a greater change in leg strength was found in the matcha group. Furthermore, a higher muscle weight in response to training for 12 weeks was found in the...
PMC10320999
Conclusions
fatigue
Collectively, matcha green tea consumption during resistance training modulates muscle adaptation. Compounds in matcha can moderate exercise-induced stress and fatigue responses, which may promote recovery after exercise and training-induced adaptation. In addition, positive correlations were found between changes in m...
PMC10320999
Authors’ contributions
M.S. and W.A. designed and coordinated the study. M.S., W.A., C.M., K.S., and R.I. performed the experiments and analyzed the data. Y.F., Y.K., and M.K. evaluated and interpreted the data. M.S. and W.A. wrote the manuscript with input from other authors. All authors critically reviewed and approved the final version of...
PMC10320999
Funding
This work was supported by the Matcha and Health Research Group and the Japan Society for the Promotion of Science (JSPS) KAKENHI: Grant-in-Aid for Scientific Research (B) (grant numbers 20H04080 and 17H02176).
PMC10320999
Availability of data and materials
The datasets used and/or analyzed in this study are available from the corresponding author upon reasonable request.
PMC10320999
Declarations
PMC10320999
Ethics approval and consent to participate
This intervention study was approved by the ethics committee of the Kyoto Prefectural University (No. 2017–146) and conducted following the tenets of the Declaration of Helsinki. Written informed consent was obtained from all participants.
PMC10320999
Consent for publication
Not applicable.
PMC10320999
Competing interests
Although the Matcha and Health Research Group was not involved in conducting experiments or data analysis, test samples were supplied from Nestlé Japan Ltd., a constituent organization of the Matcha and Health Research Group.
PMC10320999
References
PMC10320999
Introduction
Sexual double standards are social norms that impose greater social opprobrium on women versus men or that permit one sex greater sexual freedom than the other. This study examined sexual double standards when choosing a mate based on their sexual history. Using a novel approach, participants (N = 923, 64% women) were ...
PMC10303487
Sexual Double Standards at the Societal and Personal Level
SDS can exist as social norms at a Various methods have been applied for measuring SDS at a personal level. Studies using between-subject designs have offered insights into factors affecting SDS. For instance, Marks and colleagues (Only a small number of individual differences have been studied as potential moderators ...
PMC10303487
Applying Sexual Strategies Theory to Sexual Double Standards
When and where SDS exist can be informed by evolutionary theory (Sex differences in levels of parental investment depend not only on biological differences, but on contextual ones as well. Sexual strategies theory (SST) makes an important distinction between committed long-term relationships and noncommitted short-term...
PMC10303487
Applying Sexual Standards to Self Versus Same-Sex Others
The sexual standards one holds for oneself can differ from one's own We do not currently have any specific hypotheses on how this effect will look though. Primarily we aim to establish this specific appraisal for self. While one might believe that for both sexes reducing other's sexual opportunities in competition with...
PMC10303487
Methods
PMC10303487
Participants
A convenience sample of Norwegian students (
PMC10303487
Design
This was a quasi-experimental design where we applied four versions of a questionnaire. The participants were randomly assigned to respond to questions referring to either long-term or short-term MCs, and to one of the two question order versions. In the latter, participants answered about a female friend meeting up wi...
PMC10303487
Procedure
STILL
The participants received information about the study orally in classes during a break (and in writing on the first page of the questionnaire). The questionnaire was then handed out to volunteers and returned in a box within 15 min. The students did not receive any course credit or compensation for their participation....
PMC10303487
Results
PMC10303487
Sexual Acts
Principal component analysis (maximum likelihood) suggested three common factors among the sexual history items. Items measuring prior history of STI, being bisexual, or having been cheated on in a prior relationship had low communalities and was not included in the analyses. Internal consistency for the three scales w...
PMC10303487
Discussion
The study of SDS has yielded several important results. First, we found a lack of evidence for SDS effects in the traditional direction. Second, we found that people were more discerning of a prospective mate's sexual history in long-term versus short-term contexts and that women were more discerning than men. Third, w...
PMC10303487
A Lack of SDS at the Personal Level
Generally, when people are asked what norms, they believe exist in society, they tend to confirm traditional SDS (the
PMC10303487
Mating Context and Participant Sex Moderate Appraisals of Sexual History
tided
In this study, we were able to address the fact that little research has considered the role of short-term versus long-term contexts when studying SDS, taking for granted differences in sexual mating psychology that varies both by sex and mating strategy (Another moderator was the sex of the participant. In line with o...
PMC10303487
Is Sexual Hypocrisy a Specific Form of Sexual Double Standard?
’ behavior
By asking participants to make appraisals for themselves, we were in the unique position to examine sexual hypocrisy. Generally, we found that the participants were less willing to pursue an opposite-sex target following sexual history information but were less cautious when appraising same-sex friends in the same situ...
PMC10303487
Effects of Individual Differences
During our analyses, we included several covariates that one might expect to influence how people use information about sexual history including religiosity, sexual disgust, and sociosexuality. Our third prediction regarding the effect of these individual differences was supported on an overall level. Higher levels of ...
PMC10303487
Limitations
sexual behavior
The main limitation of the current work is that it was conducted on a convenience sample from a secular country which is high in sexual liberalism and has high gender egality. It is entirely possible that SDS are reduced in such countries and would reveal themselves more in countries which are more conservative and rel...
PMC10303487
Conclusion
The current study considers both SDS and hypocrisy. We have different standards for our own versus same-sex friends’ partners, and this study suggests that people are more lenient toward friends’ partners. An active sexual history represents not only opportunities but is also a risk factor. It would seem we are more ri...
PMC10303487
References
PMC10303487
Aim
The aim was to investigate whether second-year undergraduate nursing students practicing the Identification-Situation-Background-Assessment-Recommendation (ISBAR) communication approach in a desktop virtual reality (VR) application had a non-inferior learning outcome compared with the traditional paper-based method whe...
PMC10731819
Methods
A non-inferior parallel group assessor blinded randomized controlled trial, conducted in simulation sessions as part of preparation for clinical placements in March and April 2022. After a 20-minute introductory session, the participants were randomized to self-practice the ISBAR approach for 45 minutes in groups of th...
PMC10731819
Results
Of 210 eligible students, 175 (83%) participated and were allocated randomly to the VR (
PMC10731819
Conclusions
Self-practicing with the ISBAR approach in desktop VR was non-inferior to the traditional paper-based method and gave a superior learning outcome.
PMC10731819
Trial registration number
ISRCTN62680352 registered 30/05/2023.
PMC10731819
Supplementary Information
The online version contains supplementary material available at 10.1186/s12909-023-04966-y.
PMC10731819
Keywords
PMC10731819
Background
Handover of patients from one healthcare professional or organization to another is a situation in which patient safety can be threatened [When a patient undergoes surgery, a structured handover is an essential skill for healthcare workers [Within nursing education lie challenges related to resources, e.g., time, instr...
PMC10731819
Method
PMC10731819
Study design
A non-inferior, parallel group assessor blinded randomized controlled trial (RCT) was conducted at three education sites. The non-inferior approach was chosen because desktop VR simulation is done virtual and thus may have some disadvantages compared with real-life skill practice [
PMC10731819
Setting
The study was conducted as part of simulation sessions that prepared second-year undergraduate nursing students for clinical placement in medical-surgical settings. It took place in nursing programs at a university in Southern Norway (two sites) and at a university in Western Norway (one site). At the fall semester in ...
PMC10731819
Usability and pilot study
A usability study of the desktop VR application, used in the intervention in this study describes details regarding the development of the intervention [A pilot study was conducted in February 2022 with 15 third-year undergraduate nursing students at two of the sites to try out the planned RCT activities. The pilot stu...
PMC10731819
Participants
The inclusion criteria were second-year undergraduate nursing students enrolled in the nursing study program at the participating universities who had no or limited experience in supervised clinical practice in somatic hospitals. Third-year undergraduate nursing students with substantial experience in supervised clinic...
PMC10731819
Recruitment
General information about the simulation session, including that the students would be asked about participating in this study, was presented verbally during a lecture and presented in the digital learning management system for the study program. Specific information about time and place, in addition to repetition of g...
PMC10731819
Randomization and allocation
Randomization had to consider practical organization in which students participated at different times in batches of nine, 12, or 15 students; therefore, separate computer-generated randomization lists were made for each batch of students using the Microsoft Excel RAND function. Using these lists, stickers with identif...
PMC10731819
Interventions
Both the intervention and control groups participated in a 20-minute introduction session that comprised information about the simulation’s practicalities and the possibility of participating in this study, answering a questionnaire, and watching a nine-minute video that explains the ISBAR approach [The simulation star...
PMC10731819
Desktop VR application
The intervention group practiced using a desktop VR simulation called the As the tasks involved a substantial amount of written text, including instructions and patient information, and the relatively little interactions with the virtual environment, it was chosen to use a desktop VR application. The academic content w...
PMC10731819
Traditional paper-based group
The participants in the traditional paper-based group met in-person and were placed around a table in groups of three. Due to uneven numbers, two groups comprised four students. They were given printed papers with the same explanation and tasks––including an explanation of the ISBAR approach and a list of suggestions f...
PMC10731819
Differences between the groups
The main difference between the groups was that the desktop VR group practiced in a virtual environment. Furthermore, in VR, the participants were represented by avatars, with their names displayed above the avatars’ heads, and instructions were delivered through animations featuring voiceovers and pop-up windows. Feed...
PMC10731819
Data collection
At the beginning of the introduction, the participants completed a baseline characteristics questionnaire online. The outcome data were collected immediately after the simulation training through an online questionnaire and a written test, both with a time limit of 5 min. The ISBAR categories were not visible, i.e., th...
PMC10731819
Outcomes
PMC10731819
Written test and scoring rules
SECONDARY
The written test (Supplementary file The primary and some of the secondary outcomes concerned sorting patient information within correct ISBAR categories. A score of “Everything correct” was assigned if the patient information was sorted into the correct ISBAR category, independent of the order of the patient informati...
PMC10731819
Participant characteristics
Participant characteristics included sex, age, mother tongue (Norwegian or other), previous experience working in health care, previous experience working in a surgical ward, previous experience practicing using the ISBAR approach, and previous experience playing multiplayer PC games.
PMC10731819
Implementation of the intervention
Technical and other problems were registered by asking the instructors who were present if any such issues were experienced.
PMC10731819
Primary outcome
The primary outcome was the proportion of nursing students who sorted all 11 statements of patient information into the correct ISBAR order within a time limit of five minutes on the written test (Supplementary file
PMC10731819
Secondary outcomes
The proportion that placed the correct patient information within each of the ISBAR categories: This outcome reports the results for each ISBAR category and provides additional information on the primary outcome by identifying the category that was best understood, as determined by the highest proportion of correct pa...
PMC10731819
Sample size calculation
A non-inferior limit of 13 percentage points was chosen for the sample size calculation based on other studies on clinical observation [
PMC10731819
Analysis
The participant characteristics are presented descriptively. Independent sample proportion tests were used for categorical data, and independent samples t-tests were used for continuous data. The absolute difference is presented. The one-sided
PMC10731819
Results
PMC10731819
Recruitment and baseline characteristics
Altogether, 210 (78, 68, and 64 from each site) second-year undergraduate nursing students were eligible to participate in the study (Fig. The flow of participants. Abbreviations: The participants’ characteristics are presented in Table Participant characteristicsHave you previously(number answering yes):Abbreviations:...
PMC10731819
Implementation of intervention
The implementation of both groups was executed without major technical or practical problems. The desktop VR program had to be restarted for two of the 29 desktop VR groups because the participants could not talk to each other.
PMC10731819
Outcomes
SECONDARY
For the primary outcome, the group self-practicing on the desktop VR application (36% had everything correct) was non-inferior to the traditional paper-based group (22% had everything correct), with a difference of 14.2% points (one-sided 95% CI 2.9 to 14.2) on the primary outcome (Fig. The difference between the VR an...
PMC10731819
Discussion
There was a superior learning outcome of the
PMC10731819
More likeable, yet better learning outcome
It was somewhat surprising that desktop VR was found to be superior to traditional practice. The study was designed as a non-inferior study, as VR can offer some disadvantages due to technical and comprehension issues [Although desktop VR has the same learning outcome as traditional simulation, in this study and others...
PMC10731819
Potential mechanisms behind the findings
Aside from the possibility of a chance finding, we suggest five possible mechanisms to explain the superior effect and likability of desktop VR found in this study.The first is automated individual feedback. A VR application, like the one in this study, can be programmed to provide instant feedback. Feedback on perform...
PMC10731819
Strengths and limitations
This study’s main strength was the randomized controlled trial design, a relatively high number of students and a blinded assessment of the primary outcome. However, although recent findings suggest that blinding is less important than previously thought [
PMC10731819
Conclusion
This study was designed to investigate whether nursing students, self-practicing the ISBAR approach in desktop VR, achieved a non-inferior learning outcome compared with self-practicing traditional practice, which was confirmed. However, it also was found that desktop VR provided superior learning outcomes. Furthermore...
PMC10731819
Authors’ contributions
EMA
All the authors helped design the study. EMA and HB collected the data. EMA, HB, and AS analyzed and interpreted the data. All the authors helped write the manuscript and read and approved the final version.
PMC10731819
Funding
EMA
The University of Agder funded the study for EMA’s doctorate, and the Norwegian University of Science and Technology funded the application with financial support from the Research Council of Norway (260370).
PMC10731819
Availability of data and materials
The datasets used during the current study available from the corresponding author on reasonable request. It is also available from the Service Provider for the Education Sector (SIKT, reference 305866) repository at
PMC10731819