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1. Introduction | intestinal microbiome | Human gut health is closely related to sleep. We aimed to evaluate the efficacy of yeast mannan (YM) in improving bowel habits and sleep quality, along with metabolomics in fecal samples. A total of 40 healthy adults (age range, 22–64 years) with discomfort in defecation were enrolled and randomly allocated to receive ... | PMC10780920 | |
2. Materials and Methods | PMC10780920 | |||
2.1. Study Design | MAY, SECONDARY | This was a double-blind, randomized, placebo-controlled, parallel study. Participants were recruited at the Department of Medical Management and Informatics, Hokkaido Information University (Hokkaido, Japan) and randomly allocated 1:1 to each group. The allocation was conducted by a third-party organization using block... | PMC10780920 | |
2.2. Participants | The study participants included healthy Japanese adults between 20 and 64 years of age with discomfort in defecation. Sample size was calculated with G*Power 3.1 [ | PMC10780920 | ||
2.3. Tablets | YM was prepared from yeast cell walls by Asahi Group Foods, Ltd. (Tokyo, Japan), as previously reported [ | PMC10780920 | ||
2.4. Bowel Habits and Analyses of Fecal Samples | All participants were directed to record daily defecation frequency, stool volume, and stool form. Stool volume was compared with a ball-shaped model 40 mm in diameter. The stool form was evaluated according to the Bristol Stool Scale (BSS) [Fecal samples were collected per participant at the start and end of the inter... | PMC10780920 | ||
2.5. Analyses of Sleep Quality | Sleep EEG was measured by a patch-type EEG device (HARU; PGV Inc., Tokyo, Japan). The reliability of this device has already been confirmed by comparison with the International 10–20 system [ | PMC10780920 | ||
2.6. Diet Survey and Safety Evaluation | TG | ADVERSE EVENTS, EVENTS, BLOOD | The food frequency questionnaire (FFQ) was used to assess dietary and nutrient intake. Safety was assessed using diary records, medical interviews, general blood tests, and physical examinations. All adverse events (AEs) and side effects were monitored in participants who took the test tablets at least once, and the in... | PMC10780920 |
2.7. Ethics Committee | COVID-19 infection | MAY, COVID-19 INFECTION | The study protocol was approved by the Bioethics Committee of Hokkaido Information University (Hokkaido, Japan) per the principles of the Declaration of Helsinki (approval date: 28 April 2021; approval number: 2021-13). The study was registered with the University Hospital Medical Information Network (UMIN) Clinical Tr... | PMC10780920 |
2.8. Statistical Analysis | Statistical analyses were performed using SPSS version 25 software (IBM Japan Ltd., Tokyo, Japan). For intergroup comparison, parametric tests were performed using the Student’s | PMC10780920 | ||
3. Results | PMC10780920 | |||
3.1. Demographics | Eighty-two participants were initially recruited, out of which forty-two were excluded and randomly assigned to the YM or placebo treatment. | PMC10780920 | ||
3.2. Bowel Movements, Stool Volume, and BSS | Changes in defecation frequency (times/day) during the treatment period were significantly greater in the YM group than in the placebo group ( | PMC10780920 | ||
3.3. Sleep | The sleep quality was evaluated using an EEG device, and the results were summarized in | PMC10780920 | ||
3.4. Fecal Properties | Changes in both copy number (copies/g feces) and relative abundance (%) of | PMC10780920 | ||
3.5. Relationship between Fecal Metabolites and Sleep | REGRESSION | To explore the relationship between sleep quality and gut environment, forward stepwise linear regression analysis was applied using 20 differential metabolites as independent valuables. The respective sleep parameters, TIB or N3 latency time, were used as dependent variables. As | PMC10780920 | |
3.6. Safety | Changes in blood pressure, complete body composition, blood cell content, lipid parameters, renal function, and liver function were assessed. The change in Ht (%) was significantly lower in the YM group than in the placebo group (No side effects or severe or moderate AEs were observed during the intervention. Seventeen... | PMC10780920 | ||
4. Discussion | Chronic constipation, insomnia, Constipation | REGRESSION, MINOR | This study aimed to assess whether supplementation with YM would confer health benefits to healthy adults experiencing discomfort in defecation. Recently, we reported that the regular intake of YM for eight weeks improved the bowel habits of healthy women aged 30–49 years [Constipation can occur in anyone as a minor di... | PMC10780920 |
Supplementary Materials | The following supporting information can be downloaded at: Click here for additional data file. | PMC10780920 | ||
Author Contributions | N.H. | Conceptualization, J.N., N.H. and T.H.; investigation, A.H., H.K.-K., M.S., M.Y. and R.T.; resources, J.N., N.H. and T.H.; methodology and formal analysis, H.K-K.; writing—original draft preparation, R.T.; writing—review and editing, T.H. and M.Y.; supervision, N.H.; project administration, J.N. All authors have read a... | PMC10780920 | |
Institutional Review Board Statement | The study was conducted in accordance with the Declaration of Helsinki and approved by the Bioethics Committee of Hokkaido Information University (approval date: 28 April 2021; approval number: 2021-13, Ebetsu, Hokkaido, Japan). This study was registered at | PMC10780920 | ||
Informed Consent Statement | Informed consent was obtained from all participants involved in the study. | PMC10780920 | ||
Conflicts of Interest | R.T., M.Y., M.S. and T.H. are employees of Asahi Quality and Innovations, Ltd., related to Asahi Group Holdings, Ltd. The other authors declare that the research was conducted without any financial relationships that could be considered as potential conflicts of interest. The funder, SIP, had no role in the design of t... | PMC10780920 | ||
References | REGRESSION | CONSORT flow diagram.Effects of YM on bowel habits. (Effects of YM intake on the fecal metabolome. (Participant’s background characteristics (per protocol set).Numerical data are presented as mean ± standard deviation (SD). Categorical data are presented as numbers (percentages).Sleep measurements.Values are presented ... | PMC10780920 | |
Background | NMD, peripheral neuropathy or neuromuscular disease, evertor weakness, Neuromuscular disease, peripheral neuropathy, AFO | PERIPHERAL NEUROPATHY, NEUROMUSCULAR DISEASE | Neuromuscular disease and peripheral neuropathy may cause drop foot with or without evertor weakness. We developed a helical-shaped, non-articulated ankle–foot orthosis (AFO) to provide medial–lateral stability while allowing mobility, to improve gait capacity. Our aim was to evaluate the effect of the helical AFO (hAF... | PMC10176820 |
Methods | peripheral neuropathy | PERIPHERAL NEUROPATHY | Single centre, randomised crossover trial from January to July 2017 in 20 individuals (14 with peripheral neuropathy and 6 with NMD, 12 females, mean age 55.6 years, SD 15.3); 10 wore the hAFO for the first week and 10 wore the plsAFO before switching for the second week. The 6-min walk test (6MWT), Timed Up and Go (TU... | PMC10176820 |
Results | orthosis | Median [interquartile range] 6MWT distance was greater with the hAFO (444 m [79]) than the plsAFO (389 m [135], P < 0.001, Hedge’s g = 0.6) and noAFO (337 m [91], P < 0.001, g = 0.88). TUG time was shorter with the hAFO (8.1 s [2.8]) than the plsAFO (9.5 s [2.6], P < 0.001, g = − 0.5) and noAFO (10.0 s [2.6]), P < 0.00... | PMC10176820 | |
Keywords | PMC10176820 | |||
Introduction | NMD, loss of evertor strength, stroke, orthosis, AFOs, Disability, peripheral neuropathy, AFO | DISEASES, STROKE, NEUROMUSCULAR DISEASE, SECONDARY, PERIPHERAL NEUROPATHY | Diseases that affect the strength of the dorsiflexor muscles, such as stroke, peripheral neuropathy and neuromuscular disease (NMD), can result in foot drop. Foot drop restricts gait capacity and induces compensatory strategies, such as increased hip and knee flexion, to clear the foot and avoid tripping [Ankle–foot or... | PMC10176820 |
Methods | PMC10176820 | |||
Study design | orthosis, AFO | We conducted a single centre, randomized crossover trial from January to July 2017. Two types of orthoses were evaluated: a posterior leaf spring AFO (plsAFO) and the specifically designed, helical AFO (hAFO). Participants were randomised to wear one of the orthoses in their usual environment for 1 week and the other o... | PMC10176820 | |
Participants | Adult Neuromuscular Disease, spasticity, fatigue, peripheral neuropathy, AFO | AIDS, PERIPHERAL NEUROPATHY | According to the sample size calculation performed with G*Power 3.1 software (data from Nolan et al. 2009 [Inclusion criteria were: adults (over 18 years old) with unilateral drop foot caused by peripheral neuropathy or NMD who usually wore an AFO, Medical Research Council (MRC) score of the dorsiflexor or evertor musc... | PMC10176820 |
Posterior leaf spring AFO | orthosis | The plsAFO was made from a single piece of thermoformable polypropylene that encompassed the dorsal part of the leg and the sole of the foot (Fig. The same trim line was used for all plsAFOs. The proximal edge was 4 cm below the popliteal fossa. The anterior edge (medial and lateral) followed a line that passed from pr... | PMC10176820 | |
Helical AFO | orthosis, EVA foam, AFO | The helical ankle–foot orthosis (hAFO) from InnovPulse (Vernaison, France) [All the hAFOs were custom designed and fabricated from multiple layers of carbon. Layers of dry carbon fibre were superimposed between 2 closed end PVA bags over the plaster positive and epoxy resin was injected to bind the layers. The pieces w... | PMC10176820 | |
Evaluations | All participants attended 3 evaluation visits (Fig. Visit 1: the physician verified the inclusion criteria and collected demographic data (age, sex and body mass index). Strength of the dorsiflexor, evertor and plantar flexor muscles was evaluated with the MRC to characterise the participants [Visit 2: one week after w... | PMC10176820 | ||
Outcome measures | PMC10176820 | |||
Primary outcome | PMC10176820 | |||
6-min walk test (6MWT) | The 6MWT is a functional measure of gait capacity that evaluates the distance walked over a period of 6 min. The test was performed in a 30-m straight corridor. Participants were instructed to walk as far as possible within the 6 min and standardised instructions were used [ | PMC10176820 | ||
Secondary outcomes | PMC10176820 | |||
Timed up-and-go test (TUG) | The timed up and go (TUG) test measures mobility, including static and dynamic balance [ | PMC10176820 | ||
The Quebec user evaluation of satisfaction with assistive technology (QUEST) | AFO | The QUEST 2.0 (validated in French version) was used to evaluate participants’ level of satisfaction with each AFO [ | PMC10176820 | |
Harms | AFO | SKIN LESIONS | Harms were collected at each visit: participants were asked if they had experienced any skin lesions or falls or any other problems they believed were related to the AFO. | PMC10176820 |
Adherence | AFOs | Participants reported wearing both AFOs as requested, i.e., during activities of daily living. | PMC10176820 | |
3D gait analysis | Kinematic and kinetic gait variables were recorded on a 10 m runway with 8 cameras (Vicon Oxford Metrics, recording frequency 100 Hz) and 2 force platforms (AMTI OR6-7, Advanced Mechanical Technology Inc., Watertown, MA, recording frequency 1000). A set of 16 markers was fixed to bony landmarks according to the Helen H... | PMC10176820 | ||
Statistical analyses | The data did not follow a normal distribution (Shapiro–Wilk test and visual inspection). The Friedman test was used to compare the effects of the conditions (hAFO, plsAFO and noAFO) on the 6MWT, TUG test and the 13 variables from the 3D gait analysis. When significant differences were found, the Wilcoxon test was used ... | PMC10176820 | ||
TUG | All 20 participants completed the TUG test. TUG performance time was significantly affected by the condition. The post-hoc analysis showed that this time was significantly shorter (i.e., better) with the hAFO than the plsAFO (Table Mean TUG performance time is 10.4 s (SD 2.3) in healthy individuals aged 60–64 years [ | PMC10176820 | ||
3D gait analysis | orthosis, AFOs | Complete kinematic and kinetic data with at least 4 gait cycles were available for 15 participants out of the 20. Technical issues occurred for 3 participants (e.g., they placed both feet on the same force platform preventing kinetic analysis). Only one cycle was available for 2 other participants which prevented appro... | PMC10176820 | |
The Quebec user evaluation of satisfaction with assistive technology (QUEST) | All participants completed the QUEST. Median QUEST scores for the device subscale were 3.2 (IQR 0.8) for the plsAFO and 4.6 (0.9) for the hAFO, corresponding to “more or less satisfied” and “quite satisfied-very satisfied” respectively. This score was significantly higher for the hAFO condition. Median scores for the s... | PMC10176820 | ||
Harms | AFO | No harms were reported by any participants at any assessment for either type of AFO. | PMC10176820 | |
Discussion | spasticity, stroke, orthosis, AFOs, peripheral neuropathy | STROKE, PERIPHERAL NEUROPATHY, CEREBRAL PALSY | To our knowledge, this is the first study of a helical-shaped ankle–foot orthosis (hAFO) designed to reduce foot drop and improve medial–lateral stability of the ankle in individuals with peripheral neuropathy or NMD, with no spasticity. The results showed that the helical orthosis increased functional gait distance (6... | PMC10176820 |
Impact of the helical orthosis on functional gait distance and mobility | AFO, stroke, ’ | STROKE | 6MWT distance was significantly greater with the hAFO than the plsAFO, with a moderate effect size. Furthermore, almost all participants could be considered as ‘responders’ to the hAFO, which was not the case for the plsAFO, and the median change from noAFO with the hAFO largely surpassed the MCID, whereas change with ... | PMC10176820 |
Effect of the helical orthosis on biomechanical gait variables | peripheral neuropathy, weakness of the evertor muscles, AFOs, AFO | PERIPHERAL NEUROPATHY | This is one of the first studies to evaluate the impact of AFOs on biomechanical gait variables in patients with peripheral neuropathy or NMD. The purpose of this analysis was to explain the results of the functional gait tests, however fewer significant effects of the condition were found on kinematic and kinetic vari... | PMC10176820 |
Satisfaction | AFOs, neuromuscular disease | NEUROMUSCULAR DISEASE | Few studies have assessed patient satisfaction with AFOs using a validated questionnaire. We used the QUEST for this purpose since it has good reliability and validity [A study of carbon fibre Toe-OFF and BlueRocker AFOs found that 109 of 123 patients with neuromuscular disease preferred these orthoses to their previou... | PMC10176820 |
Limitations | heterogenous, orthosis, AFOs, AFO | AIDS | The inclusion of a heterogenous sample of participants with peripheral neurological and neuromuscular disorders could be considered as a limitation. However, all participants were able to walk for at least 6 min with noAFO (but gait aids such as sticks were allowed), which is typical of AFO users with foot drop that is... | PMC10176820 |
Conclusions | NMD, peripheral neuropathy, peripheral neuropathy or neuromuscular disease | PERIPHERAL NEUROPATHY | This study showed promising improvements in some outcome measures for a small group of individuals with peripheral neuropathy or NMD who have drop foot. The new hAFO improves gait capacity more, may have better biomechanical function, is more aesthetic, is lighter in weight and induces higher levels of satisfaction tha... | PMC10176820 |
Acknowledgements | Lagarde T | We warmly thank the study participants for their participation in this study and Cruz MC, Lagarde T (PhD), Serres B and Verniers R for technical assistance and assistance with data collection. We are very grateful to Orthopedie Cornier Thierry Occitane 31 for their support. We also thank Johanna Robertson for writing a... | PMC10176820 | |
Author contributions | DG, BC, PC, RG and MCAB conceived and designed the study, RD developed the software, PC, BA and MCAB recruited participants, MS performed the data acquisition, DG, RD and MS analysed the data, DG, RD, and BA interpreted the data, DG, RD and BC drafted the article, PC and BA revised the article. All authors read and app... | PMC10176820 | ||
Funding | Funding was provided by InnovPulse. | PMC10176820 | ||
Availability of data and materials | The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request. | PMC10176820 | ||
Declarations | PMC10176820 | |||
Ethics approval and consent to participate | Ethical approval was granted by the institutional review board at our facility (CPP RC31/16/8711UA 0961/2016; 2016-AO1037-44) and all participants gave informed consent for their participation. | PMC10176820 | ||
Consent for publication | Not applicable. | PMC10176820 | ||
Competing interests | orthosis | One of the authors, Benoit Caussé is the inventor of the orthosis [ | PMC10176820 | |
References | PMC10176820 | |||
Background | DM2 | TYPE 2 DIABETES MELLITUS | Type 2 diabetes mellitus (DM2) is a leading cause of morbidity and mortality worldwide and is considered a global epidemic. Despite the growing evidence on the effectiveness of mobile health interventions in the management of DM2, the evidence on the effect of mobile health interventions in prevention of DM2 is sparse.... | PMC10687681 |
Objective | DM2 | The aim of this study was to assess the usability of an app among people at risk of DM2. | PMC10687681 | |
Methods | A qualitative study with the use of a think aloud (TA) procedure was conducted from April to November 2022. The TA procedure consisted of 10 problem-solving tasks and a semistructured interview which was carried out after the tasks. These interviews served to gain more in-depth knowledge of the users experience of the ... | PMC10687681 | ||
Results | DM2 | In total, 7 people at risk of DM2 with a median age of 66 (range 41-75) years participated in this study. The analysis resulted in the following themes: (1) user interface design; and (2) suggestions for improvements of the functionality of the app. | PMC10687681 | |
Conclusions | MINOR | Overall, the participants were satisfied with the usability of the app. Through the TA-sessions, real time perspective on the appeal, relevance, and utility of the app were gained. Only minor changes to the functionality of the prototype app were reported as necessary to improve the usability of the app. Points of guid... | PMC10687681 | |
Introduction | cardiac diseases, DM2 | TYPE 2 DIABETES MELLITUS, CARDIAC DISEASES | Type 2 diabetes mellitus (DM2) is a leading cause of morbidity and mortality worldwide and is considered a global epidemic [Initiation and adherence to behavioral change is a complex process. In a previous randomized controlled trial (RCT), we found that long-term follow-up using an app to promote adherence to healthy ... | PMC10687681 |
Methods | PMC10687681 | |||
Study Design, Setting, and Participants | A qualitative study with the use of a think aloud (TA) protocol [ | PMC10687681 | ||
Theoretical Framework | Using an app as an intervention, or as a part of an intervention, can be considered as a complex intervention defined as an intervention containing several interacting components [ | PMC10687681 | ||
App Development and Main Features and Functions in Plunde | Based on previous research [Using specific behavior change strategies and techniques in different stages of change may be useful in providing support, and thereby promoting adherence to healthy behavior [In addition to goal setting, a crucial function highlighted by patients in our previous research was individualized ... | PMC10687681 | ||
TA Procedure | The TA method enabled us to identify usability issues related to Plunde via observation and self-report [The problem-solving tasks was based on real-life scenarios addressing usability testing of all the main functions of Plunde. Based on experiences from previous research conducted by the research group [ | PMC10687681 | ||
Problem-solving tasks. | nonverbal behaviors, GS | Go to the main menu and find “my goals”Find the tasks related to your goalsSend a message to your supervisorDelete a messageCreate a noteDelete the noteFind the reminders that are linked to the tasksChange a reminder that is linked to one of the tasksFind information about healthy dietFind a video about physical activi... | PMC10687681 | |
Ethical Considerations | Ethical approval was obtained from the Norwegian Centre of Research Data (ID: 887029). All included participants provided written informed consent. | PMC10687681 | ||
Results | PMC10687681 | |||
Participants and Their Characteristics | DM2 | In total, 7 people at risk of DM2 with a median age of 66 (range 41-75) years participated in this study, 3 were women and 4 were men. Regarding educational level, 1 had finished primary education, 2 had finished high school, 3 had 1-3 years of college or university, and 1 had more than 3 years of higher education. In ... | PMC10687681 | |
Usability | PMC10687681 | |||
General Findings | On average, the TA-sessions lasted for a range of 44-67 (SD 8.3) minutes. The usability based on tasks completed in the TA observation are summarized in | PMC10687681 | ||
User Interface Design | confusion | Feedback concerning the design of Plunde was mostly positive. It was pointed out by three of the participants that the layout was recognizable and similar to other apps, which made it easier to navigate based on experience. Most of the participants experienced that the menu was comprehensible. The participants had no p... | PMC10687681 | |
Suggestions for Improvements to the Functionality of the App | All the participants pointed out some flaws in the design of Plunde that could be improved. The functions related to deleting and saving, both notes, tasks, and reminders, in Plunde were the most challenging. Hence most suggestions for improvement concerned these functions.The delete function for messages was suggested... | PMC10687681 | ||
Discussion | PMC10687681 | |||
Principal Findings | DM2 | MINOR | The aim of this study was to assess the usability of an app developed to promote initiation of behavioral change and adherence to healthy behavior in people at risk of DM2. In general, only minor changes to the functionality of Plunde was reported as necessary to improve the usability. The most critical improvement inc... | PMC10687681 |
Strengths and Limitations | The sample of this study may seem small. However, previous studies have established that 80%-90% of the usability issues of web sites and apps can be detected in samples of 5 to 9 participants [The TA method has been criticized because of the high degree of self-reported data, which may jeopardize the validity of this ... | PMC10687681 | ||
Future Research | DM2 | It remains an open question how quickly test persons would adapt to the design and features of Plunde and how satisfied they would be when using it over a longer period of time. These questions are intended to be answered by an upcoming feasibility RCT where the aim is to investigate how a future full scale RCT can be ... | PMC10687681 | |
Conclusions | Feedback from the participants gained through the TA-sessions and the postactivity interviews indicated their preferences for Plunde. In general, participants were satisfied with the usability of Plunde. By asking participants to navigate through, and comment on the features in Plunde as described in the problem-solvin... | PMC10687681 | ||
Abbreviations | type 2 diabetes mellitusmobile healthPeople | type 2 diabetes mellitusmobile healthPeople Living Under changepostcardiac rehabilitationrandomized controlled trialthink aloud | PMC10687681 | |
Introduction | Soccer is likely the most popular team sport, with over 265 million FIFA-registered players worldwide [Sports nutrition aims to satisfy energy and nutrient demands while optimizing physiological adaptations and guaranteeing recovery [In general, body composition, endocrine environment, immune response, and cognitive fu... | PMC10681300 | ||
Methods | PMC10681300 | |||
Participants | The study included 19 female elite soccer players who voluntarily participated and were divided into two groups: the “controlled-diet group” (CG) (n = 10; 19 ± 1.4 years; 63.6 ± 10 kg; 164 ± 2.0 cm) and the “exchange-diet group” (EG) (n = 9; 22.5 ± 4.8 years; 61.3 ± 7 kg; 164 ± 0.1 cm). A simple randomization was perfo... | PMC10681300 | ||
Participants flow diagram. | PMC10681300 | |||
Design and procedures | A cross-sectional study was designed to evaluate the dietary intake and NK during the competitive season in elite female soccer players. On the other hand, an experimental randomized controlled trial was designed to compare the effects of two different 12-week nutrition education interventions on NK, adherence, anthrop... | PMC10681300 | ||
Energy and nutritional diet distribution during the intervention (CG and EG). | *(lunch in this Mediterranean population)During the intervention, CG followed a diet consisting of pre-established menus and food combinations. Each day, players had to select one option from four different breakfasts, seven snacks/lunches, seven main meals and seven dinners. They were not allowed to substitute any foo... | PMC10681300 | ||
Measures | PMC10681300 | |||
Dietary intake, nutritional knowledge and adherence questionnaires | Dietary intake was measured using a 7-day food record sheet that included the day of competition (Sunday), and the day before (Pre-competition, Saturday) and five weekdays (Monday to Friday) [NK was assessed using the General Nutrition Knowledge Questionnaire (NKQ) [ | PMC10681300 | ||
Anthropometric measurements | All the anthropometric measurements were taken in accordance with the standardized procedures of the International Society for the Advancement in Kinanthropometry [ | PMC10681300 | ||
Physical performance | Running speed and vertical jump performance were assessed 2 days before and after the intervention to analyze the diet-induced effect. After a protocolled warm-up, participants were requested to perform 3 repetitions of a 20-m maximum sprint, starting from a total static position 1 m behind the start line on the compet... | PMC10681300 | ||
Biochemical analysis | BLOOD | Blood analyses were performed 2 days before and after intervention at the same time of the day in a fasted and rested state. Data were obtained using an electronic hematology analyzer (Sysmex–SE9500, TOA Medical Electronics, Kobe, Japan). The outcomes measured were haemoglobin and hematocrit level, urea, iron, transfer... | PMC10681300 |
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