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2. Materials and Methods | PMC10384188 | |||
2.1. Study Design | The study design is shown in In this study, participants were required to show up three times. First, during prescreening, initial data collected included age, participation status in the competition, anthropometry, and physical health, and inclusion and exclusion (intake of healthy foods and smoking) criteria were evaluated. In addition, participants were fitted with a device that can measure the interstitial blood glucose levels. Second, the participants played the 1st test round of golf. Thereafter, the washout period was 1 week. Since the active ingredient in this study was carbohydrates, a duration of ≥6 days from the first intake was considered sufficient. Third, the participants played the 2nd test round of golf.This study was conducted following the guidelines stipulated in the Declaration of Helsinki, and all procedures were approved by the Ethics Committee of Musashigaoka Junior College, Japan (No. 21–3). In addition, this study was registered in a public database set up by the University Medical and Information Network (Study ID: UMIN000046694). | PMC10384188 | ||
2.2. Participants | interstitial glucose | MINOR | A convenience sample of 12 male competitive golfers was recruited from the Kanto Students Golf Association First Division. Based on our initial sample size calculation, we speculated that a sample of at least 12 participants was necessary to achieve a power of 0.80 with an alpha value set at 0.05. The participants were all right-handed. The participant criteria were as follows: consume healthy foods, were nonsmokers, competed in national or regional competitions, and were injury free. Moreover, the participants were informed about the experimental procedures, and they read and signed the informed consent form. If a participant was a minor, written informed consent and assent was obtained from participants (assent) and their parents/guardians (consent). Twelve participants agreed to take part in this study (response rate, 100%). Of these 12 participants, 1 was excluded from the analyses because of missing data (interstitial glucose could not be measured). Ultimately, 11 participants (84.6%) were included in the analysis (age 20.1 ± 1.0 years, body height 173.6 ± 5.9 cm, bodyweight 74.8 ± 13.7 kg, and body fat percentage 21.6 ± 6.4%). | PMC10384188 |
2.3. Procedures | This study was conducted at the Ishizaka Golf Club at Hatoyama, Hiki-gun, Saitama, Japan. The study was performed between February and March 2022. Participants were required to abstain from consuming alcohol during the evening before each round and to come to the venue without breakfast on each test day. The participants were required to report to the clubhouse 30 min before their scheduled start time. Thereafter, the participants consumed a standardized breakfast served at Ishizaka Golf Club in the starting order. During both trials, a standardized breakfast (635 kcal: 12% protein, 25.1% fat, and 48.3% carbohydrates), which consisted of rice, miso soup, salted salmon, natto, and boiled egg, was consumed between 8:00 a.m. and 8:30 a.m. on the experiment day. The energy and nutritional intake of breakfast were calculated by a dietitian using the weighing method. Nutritional intake was estimated using Eiyou-plus version 1 (Kenpakusha Co., Ltd., Tokyo, Japan) with the Standard Tables of Food Composition in Japan, 2020 Edition (8th Revision). The ACSM guidelines recommend 1–4 g bodyweight (BW) (intake per kg of BW) of carbohydrates 1–4 h before exercise [In this study, gummies (Fettuccine Gummi, Bourbon Corporation, Niigata, Japan) were used as the test food during the golf round. In Japan, gummies are commonly distributed and readily available food; in addition, it is rich in carbohydrates. Thus, in this study, we considered gummies to be a suitable food for competitive golfers in terms of real-life applications. The recommended carbohydrate intake in endurance competitions is 30–60 g per h [All participants used the same equipment (golf clubs and balls) during the two rounds. During the round, the participants carried their golf equipment in a cart and walked. The scores were tallied during the round. A putting performance test was conducted at the end of the play on each hole. Driving performances were conducted before the start, after the 9th holes, and after the 18th holes. Cognitive performance was conducted every three holes (before start and after 3th, 6th, 9th, 12th, 15th, and 18th holes). | PMC10384188 | ||
2.4. Measures and Data Collection | PMC10384188 | |||
2.4.1. Interstitial Glucose | The glucose concentration in the interstitial fluid closely correlates with the glucose concentration in the blood [ | PMC10384188 | ||
2.4.2. Golf Performance | stroke, Strokes, strokes | STROKE, STROKES, STROKES | Golf performance was evaluated by strokes, putting performance tests, and driving performance tests.ScoresThe scores were assessed to determine the difference between the participant’s number of strokes and the predetermined number of strokes for each hole. Strokes were recorded by participant self-report and accompanying research staff. Participants reported their strokes after checking with the research staff for errors.Putting performancePutting performance was evaluated on the percentage of successful putts that each participant made from the designated distance (2.5 m). Testing was performed at the end of each hole in which it was completed. The research staff determined the location of the putt. To eliminate the influence of technology, the location had to be as flat and straight as possible. The putters and balls were those used by each participant in the play. No practice was performed, and one measurement was performed. Success was achieved if a player made the cup in one stroke.Driving performanceDriving performance was evaluated on three items: club head speed (CHS), distance, and accuracy. Driving performances were made using TrackMan 4 (TrackMan Japan Inc., Tokyo, Japan). The TrackMan 4 is used by low- and high-handicap golfers based on its accuracy [Tests were conducted in the starting order. Five driver shots were performed, and participants rested between shots for 60 s; the testing session of each participant lasted for 10 min. Participants were blinded to their values from the monitor. | PMC10384188 |
2.4.3. Cognitive Performance | Cognitive performance was evaluated using an adapted visual analog scale (VAS) questionnaire [Participants completed a VAS questionnaire (a questionnaire consisting of words describing minimum/maximum status marked at the left and right ends of a 100 mm long line drawn horizontally). | PMC10384188 | ||
2.4.4. Other Variables | Age and status of participation in the competition were self-reported. Body height was measured using a stadiometer (YHS-200D, YAGAMI Inc., Nagoya, Japan). Bodyweight and body fat percentage were measured by bioelectrical impedance analysis (InBody 470, InBody Japan Inc., Tokyo, Japan). Body height (to the nearest 0.1 cm), bodyweight (to the nearest 0.1 kg), and body fat percentage (to the nearest 0.1%) were measured with the participants wearing lightweight outdoor clothes without shoes.Weather conditions were recorded for each trial date, including ambient temperature, wind speed, wind direction, and precipitation. Data were collected from the Hatoyama Meteorological Agency Observatory, which is located near the golf course [ | PMC10384188 | ||
2.4.5. Data Analysis | The CGM systems have an inevitable time delay, which is relevant under exercise [ | PMC10384188 | ||
2.4.6. Statistical Analyses | All statistical analyses were performed using JMP version 14.3.0 (SAS Institute Inc., Cary, NC, USA). All data are expressed as mean ± standard deviation. Data normality was evaluated using the Shapiro–Wilk test. A two-way analysis of variance (trial × time) with repetition was used to compare measurements across trials. Eta squared (η | PMC10384188 | ||
3. Results | PMC10384188 | |||
3.1. Weather and Putting Green Conditions | Each trial date was similar, no rainfall was recorded, the ambient temperature was around the average temperature for March (7.5 °C), the average wind speed was around the average speed for March (1.9 mph), and the wind direction was north–northwest for both days [ | PMC10384188 | ||
3.2. Interstitial Glucose | There were main effects for trial and time for interstitial glucose (trial: | PMC10384188 | ||
3.3. Golf Performance | The scores were significant for the main effects of the trial; however, significance for the main effects of time was noted (trial: The driving distance was not significant for the main effects of the trial; however, significance for the main effects of time was found (trial: | PMC10384188 | ||
3.4. Cognitive Performance | PLF | PLF was a main effect of the trial and time (trial: There were main effects for trial and time for PLC (trial: The value of the CHO intake during the golf round was higher than that of the start. PLR was not significant for the main effects of trial and time interactions (trial: | PMC10384188 | |
4. Discussion | interstitial glucose decline, fatigue, PLF | In this study, we found that the continued carbohydrate intake with gummies during a round of golf, although not found to be effective on golf performance, may prevent the reduction of interstitial glucose levels and attenuated fatigue in the controlled study. Moreover, gummy intake had the potential to sustain concentration during a round of golf.Continuous carbohydrate intake with gummies was found to prevent interstitial glucose decline on the 4th–6th, 7th–9th, 10th–12th, 13th–15th, and 16th holes. In addition, no decrease in interstitial glucose levels was observed in the second half of the round (In the present study, the participants ate a breakfast containing 1.02 kg BW of carbohydrates per kg BW. A previous study reported that if a pre-exercise carbohydrate-rich meal is combined with the ingestion of carbohydrates during exercise, then the improvements in endurance capacity during cycling [Continuous carbohydrate intake with gummies was found to reduce the increase in PLF on the 6th, 9th, 12th, 15th, and 18th holes (Moreover, continuous carbohydrate intake with gummies was found to reduce the decrease in PLC on all 18 holes (In this study, the continuous intake of carbohydrates with gummies did not affect driving performance. Previous studies have reported an association between fatigue and decreased driving performance using various test diets [In this study, the 2.5 m putt success rate was not significant for the main effects of trial and time (In this study, scores were not significant for the main effects of trial and time. On the USPGA Tour, 61–87% of the scores can be explained by driving distance, fairway percentage, par on percentage, and putts made [A main effect of time was noted on putting success (A main effect of time was found on the driving distance (To the best of our knowledge, this is the first study whose results demonstrate that continuous intake of carbohydrates during a round of golf attenuated the decline in interstitial glucose level and prevented fatigue from the middle of the golf round, and concentrations were maintained in the last half of the round of golf. Furthermore, the results showed a simultaneous increase in the fatigue level and decrease in interstitial glucose levels. Therefore, as a practical application, competitive golfers should plan nutritional supplementation to maintain interstitial glucose during a round of golf. Although gummies were selected for this study because of their easy availability, this could be achieved using other foods, such as bread, rice balls, and dried fruits, which have high carbohydrate contents and are easy to consume. Competitive golfers should consume these carbohydrate-rich foods on a sustained basis to prevent fatigue when playing golf.The strength of this study was attributed to the use of a standardized real-life application study design and on-course testing and measurement of interstitial glucose levels during a round of golf and anthropometric data of competitive golfers. This study had several limitations. First, this study was conducted with an open-study design, and no placebo was set. Placebo gummies with noncaloric artificial sweeteners were not ethically used in this study because they exceeded the maximum no-action dose. Therefore, the study design may have influenced the cognitive performance results to a small degree. Second, carbohydrate-supplemented gummies were used; however, the effect of chewing could not be eliminated. Previous studies have shown that chewing is associated with attenuated brain activity [ | PMC10384188 | |
5. Conclusions | fatigue | In this study, continuous carbohydrate intake had no effects on golf performance. On the contrary, the continuous intake of carbohydrates during the golf round attenuated the decline in interstitial glucose level and prevented fatigue in the controlled trial from the middle of the golf round, and concentration was maintained in the last half of a round of golf. These findings suggest that continuous carbohydrate intake with gummies may be effective in attenuating fatigue and maintaining the concentration of competitive golfers. Thus, this study can propose nutritional strategies for competitive golf. | PMC10384188 | |
Author Contributions | Conceptualization, Y.N., K.E. and Y.E.; methodology, Y.N.; validation, Y.N.; formal analysis, Y.N.; investigation, Y.N., K.E., Y.E., A.M. and K.K.; resources, Y.N. and K.E.; writing—original draft preparation, Y.N.; writing—review and editing, Y.N. and Y.E.; visualization, Y.N.; supervision, Y.N. and K.E.; project administration, Y.N., K.E. and A.M.; funding acquisition, S.M. All authors have read and agreed to the published version of the manuscript. | PMC10384188 | ||
Institutional Review Board Statement | This study was conducted in accordance with the Declaration of Helsinki and approved by the Ethics Committee of Musashigaoka Junior College, Japan (No. 21–3, 29 January 2022). | PMC10384188 | ||
Informed Consent Statement | MINOR | Informed consent was obtained from all subjects involved in the study. If the participant was a minor, written informed consent and assent was obtained from participants (assent) and their parents/guardians (consent). | PMC10384188 | |
Data Availability Statement | The underlying research materials related to this paper are available from the corresponding author upon request. | PMC10384188 | ||
Conflicts of Interest | The authors have financial conflicts of interest to disclose concerning the study. This study was supported by Bourbon Corporation. Shigeru Mineo is an employee of Bourbon Corporation. He did not participate in the experimental design, data collection, data analysis, interpretation of the data, writing of the manuscript, or in the decision to publish the results. | PMC10384188 | ||
References | Study Design.((Weather and putting greens conditions on trial day. | PMC10384188 | ||
Introduction | leucorrhea, vaginitis, ’ vaginal, bacterial vaginitis, dysbiosis, Vaginitis, vaginal itching, Infection | ADVERSE REACTIONS, INFECTIOUS DISEASES, VAGINITIS, DISEASE, BACTERIAL VAGINITIS, VAGINITIS, INFLAMMATION OR INFECTION, INFECTION | Edited by: Tingtao Chen, Nanchang University, ChinaReviewed by: Huaxi Yi, Ocean University of China, China; Qixiao Zhai, Jiangnan University, China; Faizan Ahmed Sadiq, Institute for Agricultural, Fisheries and Food Research (ILVO), BelgiumThis article was submitted to Clinical Microbiology, a section of the journal Frontiers in Cellular and Infection MicrobiologyVaginitis is the most common disease in gynecology. Vaginal dysbiosis is a main reason of bacteria vaginitis (BV), as the disrupted microecological environment facilitates the growth of various vaginal pathogens. The most dominant bacteria in the vaginal microbiota are lactic acid bacteria, which are important for maintaining vaginal health. At present, antibiotics and other drugs are often used in clinical treatment, but there are many adverse reactions and easy to relapse, and the intervention of probiotics can help restore vaginal microbiota and alleviate BV. This study is a human clinical trial of 50 patients with bacterial vaginitis (BV). The alleviation effect of applying a postbiotic gel for one week in BV was evaluated. Changes in patients’ clinical indicators of BV (properties of vaginal secretion) and the vaginal microbiota after using the postbiotic gel were monitored. Our results showed that apply the postbiotic gel improved the symptoms of BV, indicated by improvement in the abnormalities of patients’ vaginal secretions. After applying the gel, the relative abundance of vaginal lactobacilli increased compared to baseline. Significant negative correlations were found between lactobacilli and potential vaginal pathogens (including Vaginitis is one of the most common infectious diseases in female gynecology. It is mainly due to inflammation or infection of the vaginal area, and the clinical symptoms of which include vaginal itching, irritation, and discharge of secretion with unpleasant odor (The structure of the vaginal microbiota comprises mainly lactobacilli, and this group of microbes is thus indicative of vaginal health and homeostatic for the local acidic environment (pH < 4.5) (Probiotics are active microorganisms that confer beneficial effects on the host (Clinical identification of BV mainly relies on traditional methods of pap smear and biochemical analysis (This study recruited 50 patients with BV and investigated the therapeutic effect of one-week intervention with postbiotic gel. Changes in the severity of leucorrhea, biochemical properties and bacterial microbiota of subjects’ vaginal discharge after the gel intervention were analyzed. This study supports that the application of postbiotic gel could improve BV. | PMC9936311 |
Materials and methods | PMC9936311 | |||
Trial design and volunteer recruitment | allergic, metabolic abnormalities | This was a clinical trial conducted between January 2020 to March 2020 at the Department of Obstetrics and Gynecology of Kunming Tongren Hospital. Patients with BV were selected for a one-week intervention of a postbiotic gel to measure changes in the properties of vaginal discharge and vaginal microbiota before (day 0) and after (day 7) intervention. All (n = 50) patients diagnosed with BV at this hospital were considered for participation in the study and were screened by hospital professionals for eligibility. The inclusion criteria were: (1) women clinically diagnosed with diagnostic criteria for BV, aged 18-55 years; (2) body mass index between 19-24; (3) no history of heart, liver, lung, kidney, digestive tract, nervous system, and metabolic abnormalities; (4) not taken other vaginal preparation drugs 30 days before this trial; (5) voluntarily signed the informed consent. Subjects that were allergic to the postbiotics gel were excluded from this study (Trial design and enrollment information. | PMC9936311 | |
Postbiotic gel preparation | The postbiotic gel used in this work was produced by Qingyitang Industrial Co., Ltd. (Yunnan, China). Probiotic strains were provided by the Lactic Acid Bacteria Collection Center of Inner Mongolia Agricultural University (Hohhot, China). The gel was prepared by mixing the raw materials (The ratio of raw materials and the amount of probiotics inoculated. | PMC9936311 | ||
Postbiotic gel application, collection and analysis of vaginal secretions | vaginosis, leucorrhea, vulvar itching | VAGINOSIS, STERILE, VAGINA | Participants was registered to participate in this trial by providing basic demographic information (age: 35.8 ± 8.96) before the start of the trial. The gel was applied every night and avoided the menstrual period. To apply the gel, subjects first cleaned their hands and vulva with warm water, took a product, slightly lifted the hips in a supine position, slowly inserted the gel catheter containing the gel into the deep part of the vagina, pushed it into the pubic area with a pusher, and maintained the posture for about 15 minutes. The product was applied every night for seven days.Sample collection is carried out by professional doctors. Fresh vaginal secretions were collected with sterile cottons before the start of medication and the next day of the last gel application. In order to obtain fresh samples, we collect the secretions of volunteers according to strict methods and submit them for examination as soon as possible. First of all, sterile cotton swabs were gently rotated in the subjects’ posterior vaginal fornix to collect fresh vaginal secretions. After sampling, cottons with the samples were placed in test tubes containing physiological saline and stored at -80°C until further processing. At the same time, symptoms of subjects, including severity of vulvar itching and leucorrhea, color and odor of vaginal secretions were recorded. The biochemical and microbiological properties of vaginal secretion were determined in the laboratory within 30 minutes of sample collection by a medical professional. Hydrogen peroxide test was performed using a combined aerobic vaginitis/bacterial vaginosis five-item qualitative test kit (based on an enzyme-chemical reaction method; CSC Goldfield Diagnostics, Beijing, China). The presence of lactobacilli, fungi, and the cleanliness of collected samples were observed using a microscope (Olympus Corporation of Japan). The pH of the vaginal secretion was determined using pH test strips. All assessments were operated by professional doctors or personnel, and the data were entered and confirmed by more than two medical staff to ensure data consistency and accuracy. A total of 50 subjects completed the clinical assessment in the trial, and 47 subjects provided a complete sample (two vaginal secretions). | PMC9936311 |
Sequencing of bacterial microbiota in the vaginal samples | The metagenomic DNA in the collected vaginal secretions was extracted by QIAamp kit (Qiagen, Hilden, Germany), and the purity and concentration of the extracted DNA were detected by Nanodrop (Thermo Fisher Scientific, USA) and agarose gel electrophoresis. Qualified DNA samples were amplified, targeting to the 16S rRNA V4 region using barcoded region-specific primers, 515F (GTGYCAGCMGCCGCGGTA) and 806R (GGACTACHVGGGTWTCTAAT). The amplification conditions were pre-denaturation at 95°C for 1 min; denaturation at 95°C for 30 s; annealing at 60°C for 40 s; extension at 72°C for 1 min, for a total of 30 cycles; terminal extension at 72°C for 7 min and termination at 4°C. Amplified samples were checked by agarose gel electrophoresis for the amplicon product size and purity. Follow-up analysis was only performed on amplicon products appearing as a single and bright band.The samples that met the quality requirement were used for DNA library construction and sequenced using the Illumina novaseq PE250 platform. The original sequences were quality controlled and grouped by the sample nucleotide barcode. Microbial diversity analysis was performed using the QIIME platform ( | PMC9936311 | ||
Statistical analyses | For α diversity analysis, QIIME (version 1.9.1) was used to calculate the Shannon index, chao1 index, and Simpson index. The Shannon curve and the observed species number curve were plotted using R (version 4.2.1), which were used to assess the bacterial diversity of each sequenced sample and the sequencing depth. Wilcoxon tests were used to evaluate the α diversity between samples collected at the two time points. β diversity (weighted and unweighted Unifrac) was calculated by R packages (vegan), and principal coordinate analysis (PCoA) was used for descending presentation. Association between β diversity and study groups was assessed using a non-parametric analysis of similarities (Adonis, vegan R package) with 999 permutations. Followed by comparative analysis to identify significant differential marker bacteria of treatment (cut-off: | PMC9936311 | ||
Results | PMC9936311 | |||
Improvement in subjects’ clinical indicators after postbiotic gel application | Vulvar pruritus, vaginal itching, vaginitis | VAGINAL INFLAMMATION, REMISSION, VAGINITIS | In our study, 50 people completed clinical indicators, including 45 people who completed vaginal discharge collection before the intervention and 42 people after the intervention. After matching, the per-protocol population was 42, who completed the process of clinical information collection and provision of vaginal secretion for microbiota sequencing analysis before and after using the postbiotic gel. The vaginal sample of a healthy woman is transparent or milky white, with no odor and in a small amount. A large amount of vaginal secretion that is thin, homogeneous, and of fishy odor is indicative of vaginal inflammation (Changes in vaginal secretion properties and biochemical parameters after the use of postbiotic gel.Vulvar pruritus is one of the reference indicators for evaluating vaginitis. Three among the 50 patients in this study complaint about vaginal itching at the start of the trial, and the symptom remained only in one subject after using the postbiotic gel. A high level of vaginal secretions cleanliness (the cleanliness rating is closer to IV) and positive reaction in hydrogen peroxide test indicate poor BV or at least poor vaginal health. Initially, 47 patients showed a positive result for hydrogen peroxide, and 18 (remission rate = 38.3%) of them showed a negative hydrogen peroxide result after using the gel. Moreover, 29 people had a cleanliness grade of III or IV, and most (18) of them showed significant improvement after using the postbiotic gel. These data suggested that applying the postbiotic gel for a week could improve BV and vaginal health. | PMC9936311 |
Changes in the α-diversity of vaginal microbiota after the intervention | A total of 5,479,608 high-quality sequences were obtained from 87 (Before: n = 45; After: n = 42) sequencing samples. The rarefaction curves of the Shannon diversity (α-diversity analysis of vaginal microbiota before and after the use of the postbiotic gel. Rarefaction curves of In order to study the difference between the two groups of samples, the samples were screened, and the samples that could not be paired were excluded, and a total of 42 pairs of samples were obtained. The chao1, number of observed species, Shannon, and Simpson indexes of the vaginal microbiota of subjects were analyzed, and decreasing trends were observed in all four measured diversity indexes after using the postbiotic gel, though the differences were not statistically significant ( | PMC9936311 | ||
β-diversity analysis, identification of differential bacteria before/after the gel intervention | Changes in the β-diversity of the vaginal microbiota was analyzed by PCoA (weighted and un-weighted Unifrac), which revealed no significant differences before/after the gel intervention (Changes in the β-diversity of vaginal microbiota and differential abundant bacteria identified after using the postbiotic gel. We used microscopy to analyze | PMC9936311 | ||
Changes in the predicted function of the vaginal microbiota after postbiotic gel application | We then used PICRUSt2 to predict functional changes in the vaginal microbiota after using the postbiotic gel (Changes in the functional microbiota predicted by PICRUSt after applying the postbiotic gel. Eight significant differential KEGG pathways (t-test; | PMC9936311 | ||
Correlation between dominant microbiota and clinical features of the vaginal secretion | ’ vaginal | HEAT | According to our clinical observation, we selected the common clinical symptoms and signs, and referred to the symptom scoring standard in the Guidelines for Clinical Research on New Chinese Medicines (for Trial Implementation). For evaluating the amount of secretion: a small amount was scored as 2, a medium amount was scored as 1, and a large amount was scored as 0. For evaluating the nature of secretion: a thin amount was scored as 1, and a thick amount was scored as 0. For evaluating the odor of secretion: an odorless amount was scored as 1, and an odorous amount was scored as 0. For evaluating the color of secretion: a clear color was scored as 3, a light yellow color was scored as 2, a yellow color was scored as 1, and a green color was scored as 0. Then we used Spearman’s correlation analysis to analyze the association between the dominant bacterial genera and clinical features of the collected vaginal samples (Spearman’s Correlation heat maps showing association between dominant bacteria and properties of subjects’ vaginal secretion. The color scale shows the strength of correlation (ranging from 1 to -1, representing strong positive to strong negative correlation). * | PMC9936311 |
Discussion | vulvovaginal candidiasis, ’ vaginal | RECURRENCE, VAGINA, VULVOVAGINAL CANDIDIASIS | The colonization of lactic acid bacteria plays an important role in maintaining vaginal homeostasis by inhibiting other pathogens, and the colonization of anaerobic bacteria is often related to the occurrence of BV (A randomized, double-blind, placebo-controlled trial evaluated the routine treatment of BV or vulvovaginal candidiasis for five days with probiotic capsule, revealing improvement in symptoms, which was accompanied by lactobacilli colonization of the vagina, reduced recurrence rate, and reduced odor in the vaginal discharge, which is consistent with our findings (In this study, we found no significant difference in the α diversity of vaginal microbiota showed a non-significant reduction after using the postbiotic gel. It is important to note that, contrasting to the gut microbiota, a healthy vaginal microbiota has a low bacterial diversity. A high vaginal microbiota diversity increases the probability of BV (
Then, a correlation analysis was performed between the dominant genera of the vaginal microbiota and properties of subjects’ vaginal secretions. Again, we found a significant negative association between lactobacilli and potential pathogens like In conclusion, our study showed that applying the current postbiotic gel could improve the patients’ symptoms of BV, and the symptom improvement was accompanied by significant changes in patients’ vaginal microbiota, characterized by an increase in lactobacilli and a reduction in multiple potential vaginal pathogens. Our data supported that postbiotics application could improve vaginal health and ease BV. Our findings have a high application value in clinical practice. | PMC9936311 |
Limitations | There are some limitations in our study. Firstly, the number of subjects included in this trial. was small, and the number of subjects should be increased in subsequent studies with the inclusion of a placebo control group of healthy subjects for a baseline of vaginal microbiota in comparison with subjects with BV. Secondly, 16S rRNA gene amplicon sequencing only represents the genus-level genome without providing any information on gene or protein expression, which would provide more functional information (M. T. | PMC9936311 | ||
Data availability statement | All sequence data generated in this study were submitted to the MG-RAST database under the ID number mgp95926. | PMC9936311 | ||
Ethics statement | The studies involving human participants were reviewed and approved by independent committee members. The patients/participants provided their written informed consent to participate in this study. Written informed consent was obtained from the individual(s) for the publication of any potentially identifiable images or data included in this article. | PMC9936311 | ||
Author contributions | XS: Formal analysis, data curation, visualization, writing of the original draft. LX: Clinical trial implementation, specimen collection. ZQZ: Conceptualization, design of methodology. YTY and PXL: Formal analysis, software testing and verification. TM and SG: Supervision of clinical trial, manuscript revision. L-YK: Writing, critical evaluation and revision of the original draft, resource provision. ZHS: Conceived and designed the experiments. All authors contributed to the article and approved the submitted version. | PMC9936311 | ||
Acknowledgments | We would like to thank all the researchers, clinicians, and subjects for their participation in this study. | PMC9936311 | ||
Conflict of interest | Authors ZQZ, YTY, and PXL were employed by company Qingyitang Industrial Co.,.The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. | PMC9936311 | ||
Publisher’s note | All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher. | PMC9936311 | ||
Supplementary material | The Supplementary Material for this article can be found online at: Differential bacterial genera identified before and after using the postbiotic gel.Click here for additional data file.Differential pathway identified before and after using the postbiotic gel.Click here for additional data file.Spearman correlation analysis between vaginal discharge and differential genera.Click here for additional data file. | PMC9936311 | ||
References | PMC9936311 | |||
1. Introduction | obesity, cancer | OBESITY, CANCER | Motivational interviewing (MI) is a promising behavioral intervention for improving parent and adult caregiver (PAC) health behavior for obesity and cancer prevention. This study explored the preliminary effects of MI from a registered dietitian (RDMI) within an obesity prevention intervention to promote PAC behavior change and positive proxy effects on children and the home environment. N = 36 PAC/child dyads from low-resource communities were enrolled in a randomized trial testing a 10-week obesity prevention intervention. Intervention dyads were offered RDMI sessions. Data were collected at baseline and post-intervention (PAC diet quality (Healthy Eating Index (HEI)), child skin carotenoids, home environment, and PAC ambivalence regarding improving diet). Results show that for every RDMI dose, PAC HEI scores increased (0.571 points, The presence of obesity has been identified as a key factor in the development of multiple preventable cancer types [Given the novelty of PAC-focused MI, rigorous methods are warranted (e.g., use of trained interventionists, fidelity monitoring, integration with behavior- or outcome-specific treatment modalities) [ | PMC10048747 |
2. Materials and Methods | PMC10048747 | |||
2.1. Participants and Recruitment | communication disabilities | RECRUITMENT, MALABSORPTION, PACS | Parents/adult caregivers and one 8–9-year-old child from the central Ohio area were invited to participate as dyads. Recruitment occurred via communication with local schools that received federal funding for free, as well as reduced-price, breakfast and lunch to students, in order to target dyads from low-resource/under-resourced communities. Interested PACs were screened for eligibility prior to scheduling a baseline orientation/data collection visit. Additional inclusion criteria included the following: (1) fluent English-speaking dyads and (2) ability to consume fruits and vegetables without concerns of medication–nutrient interactions. Exclusion criteria included the following: (1) diagnosed with mental, physical, or communication disabilities, or difficulties that would impair full participation in all components of the intervention; (2) lack of transportation to weekly classes; (3) non-English speaking; (4) consuming over-the-counter herbals, botanicals, or nutritional supplements (excluding multivitamins); (5) diagnosed with active metabolic or digestive illnesses, which may result in nutrient malabsorption. Participating caregivers were required to be a primary caregiver responsible for food procurement and preparation for the participating child, though no specific relationship was required (e.g., mother/father, aunt/uncle). All procedures were performed in accordance with the ethical standards of The Ohio State University’s institutional review board and the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards. | PMC10048747 |
2.2. Study Design | obesity | OBESITY | The Summer Harvest Adventure is a five-year, randomized controlled trial designed to determine the efficacy of a multicomponent obesity prevention intervention to improve the consumption of fruits and vegetables in youth; RDMI was offered as one intervention component. Enrolled participants were randomized to the intervention, The Summer Harvest Adventure, or an education-only control, My Summer Plate ( | PMC10048747 |
2.3. Weekly Intervention Sessions | Each week of the intervention included education focused on obesity-preventive behaviors, including foundational healthy habits (e.g., avoidance of sugar-sweetened beverages), with an emphasis on fun physical activity and improving adherence to the US Dietary Guidelines for Americans [ | PMC10048747 | ||
2.4. Remote Motivational Interviewing from a Registered Dietitian (RDMI) | weight loss | PACS | As part of the intervention, each PAC was introduced to the RD providing RDMI at baseline data collection visits (RDMI interactions focused on issues related to the dietary patterns of PACs; PACs were able to discuss other related topics of interest (e.g., weight loss) if desired. If PACs brought up questions regarding their child’s health (e.g., picky eating), the RD would answer these questions by drawing connections to PAC’s own dietary patterns. If requested, additional resources were delivered to PACs via email, however, counseling occurred only via phone. | PMC10048747 |
2.5. Data Collection | Comprehensive data collection visits occurred before and after (i.e., baseline and post-intervention) the ten-week intervention period for dyads, during which data were recorded using Research Electronic Data Capture (REDCap) tools hosted at The Ohio State University [ | PMC10048747 | ||
2.6. Survey Measurements | Attitudinal ambivalence | At baseline, sociodemographic questions adapted from the Behavioral Risk Factor Surveillance System were administered [Attitudinal ambivalence was assessed using the validated Change Questionnaire [ | PMC10048747 | |
2.7. Dietary Patterns and Diet Quality | Cancer | CANCER, PACS | PACs completed the National Cancer Institute’s Diet History Questionnaire III (DHQIII) [ | PMC10048747 |
2.8. Anthropometric and Clinical Measurements | PACS | For dyads, height was measured with a seca 213 portable stadiometer (seca North America, China, CA). Weight was measured on a Tanita SC-331S Total Body Composition Analyzer (Tanita, Arlington Heights, IL, USA). Height and weight were used to calculate body mass index (BMI) for PACs in kg/m | PMC10048747 | |
2.9. Interaction and Process Data | PACS | Data on all interactions with the RD were recorded. Each interaction was coded as a reciprocal interaction (RI) if the participant responded to the RD’s communication in any capacity, regardless of the content of the response. Each RI was then further classified as a dose of RDMI if the RD and participant engaged in a two-way interaction that resulted in MI, MNT, nutrition counseling, or nutrition education. Based on this coding, use was defined four ways: (1) The Health Care Climate Questionnaire (HCCQ) was administered to PACs at post-intervention to assess their perceived autonomy [ | PMC10048747 | |
2.10. Attendance and Participation | PACS | Dyad participation in the other intervention components was collected. At each weekly session, dyad attendance was collected. Although dyads were encouraged to attend these activities together, PACs could attend independently if the child was unable to do so, while children could attend alone as long as they were accompanied by an adult caregiver. Ten total sessions were offered, and the total number of sessions attended by either member of the dyad were summated. | PMC10048747 | |
2.11. Fidelity to MI | With PAC approval, phone calls were audio-recorded for the purposes of MI fidelity assessment. Recordings were selected at random and reviewed with the Motivational Interviewing Treatment Integrity Tool (Version 4.2.1) [ | PMC10048747 | ||
2.12. Statistical Analyses | PACS | Descriptive statistics were computed for PAC socio-demographics, baseline characteristics, and measures of RDMI use. For the purposes of baseline descriptions, the cohort was defined in three ways: (1) all PACs who were classified as Pearson correlations were used to explore the relationship between measures of RDMI use, percent change in HEI scores, and percent weight change from baseline to post-intervention; Spearman correlations were used to evaluate the correlation between | PMC10048747 | |
3. Results | PMC10048747 | |||
3.1. Baseline Characteristics and Measures of RDMI Use | REGRESSION, PACS | Thirty-six PACs were enrolled in the Summer Harvest Adventure; 78% (n = 28) participated in at least one RDMI session, and 44% (n = 16) were considered Logistic regression was utilized to determine the likelihood of classification as a | PMC10048747 | |
3.2. Ambivalence | A strong statistically significant relationship was found between percentage change in Change score from baseline to post-intervention and | PMC10048747 | ||
3.3. PAC Clinical Outcomes and Diet Quality | PACS | A weak positive correlation between measures of RDMI use and percentage weight change among PACs existed (e.g., | PMC10048747 | |
3.4. Child and Home-Related Outcomes | The lowest contribution towards child skin carotenoids was noted for | PMC10048747 | ||
3.5. Programmatic Evaluations and Autonomy | PACS | Fifty-eight percent of PACs (n = 14) rated RDMI as “excellent”, 21% (n = 5) as “very good”, and 4% (n = 1) as “good”; 17% (n = 4) stated they “did not use” RDMI. Of those, n = 2 did not engage in any RDMI interactions. However, n = 2 did, reporting “Did not really know what to discuss…and find the recipes helpful we learned at the garden study…” and “I am already well-versed in nutrition and healthy living and employ those practices in my everyday life, consistently.” Participants who completed at least one RDMI session reported a mean score of 6.5 out of 7 (SD = 0.87, range 4.3–7) on the Health Care Climate Questionnaire. | PMC10048747 | |
4. Discussion | obesity | OBESITY, REGRESSION, PACS | The objective of this study was to explore the preliminary effects of PAC-focused RDMI on outcomes among dyads in a multicomponent obesity prevention intervention. Addressing PACs in this context is critical [A primary advantage of using MI is its focus on the psychological and/or cognitive predictors of behavior change (e.g., ambivalence) versus an emphasis on passive education/knowledge, or more paternalistic approaches. Such an appreciation for the varying predictors of, and/or contributors to health behavior and its related outcomes (e.g., psychological factors, mental health), is essential for prevention strategies. This characteristic of MI may contribute to its potentially positive effect on health outcomes among underserved populations, including diverse populations [African American participants were more likely to be classified as This study documents that RDMI use was associated with improvements in PAC health behavior. Specifically, for every one-unit increase in Further, RDMI in this study was one component of a multicomponent intervention, and interest remains in understanding the unique contributions of RDMI as an “active ingredient.” Attendance/participation in other study components did contribute to diet-related outcomes, though to varying degrees, and in some instances, RDMI demonstrated a greater contribution. Results of logistic regression indicate that PAC BMI was the strongest predictor of RDMI completion. The literature indicates that confronting weight status may negatively impact treatment engagement and outcomes; thus, the lack of focus on these issues in this study highlights a strength [Despite MI’s role in addressing ambivalence [This study had numerous strengths, including a detailed examination of MI from a RD, including in a diverse cohort, as well as for the purposes of modifying PAC behavior in the context of a child-focused pediatric obesity prevention intervention. However, this study is not without limitations. As data for one year of the overarching five-year trial are presented, the sample size is small, limiting interpretation and potentially explaining the absence of statistical significance. In addition, in this study, the short-term follow up may be insufficient to observe sustained changes in health or behavior, and limit the interpretation of long-term or sustained implications. In conclusion, results indicate MI from a RD delivered to PACs can improve ambivalence regarding diet quality, as well as measures of diet, in both PACs and youth, including among PACs with high ambivalence. | PMC10048747 |
Supplementary Materials | The following supporting information can be downloaded at: Click here for additional data file. | PMC10048747 | ||
Author Contributions | Conceptualization, A.B., J.P., L.W., K.P., A.D. and C.K.S.; methodology, A.B., J.P. and C.K.S.; formal analysis, A.B. and M.X.; investigation, A.B. and C.K.S.; data curation, A.B.; writing—original draft preparation, A.B.; writing—review and editing, A.B., J.P., M.X., L.W., K.P., A.D. and C.K.S.; supervision, C.K.S.; project administration, A.B. and C.K.S.; funding acquisition, C.K.S. All authors have read and agreed to the published version of the manuscript. | PMC10048747 | ||
Institutional Review Board Statement | The study was conducted in accordance with the Declaration of Helsinki, and approved by the Institutional Review Board of The Ohio State University (IRB# 2017B0110, approved 6 July 2017). | PMC10048747 | ||
Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. | PMC10048747 | ||
Data Availability Statement | Data may be made available upon reasonable request. | PMC10048747 | ||
Conflicts of Interest | The authors declare no conflict of interest. | PMC10048747 | ||
Abstract | PMC10770821 | |||
Objective | To investigate the effect of music on heart rate recovery (HRR) and heart rate variability (HRV) after intense exertion. | PMC10770821 | ||
Methods | Five hundred male students enrolled at Yongin University, Korea, underwent a cycling test to assess aerobic capacity; 180 students with equal scores were selected for a music intervention, which was conducted after vigorous exercise. The 180 participants were randomized into three music groups and a control group; the participants in each music group listened to music at three different tempos: slow ( | PMC10770821 | ||
Results | The results revealed no significant variation in HRR and HRV indexes between the four cohorts ( | PMC10770821 | ||
Conclusion | high‐intensity | After rigorous activity, listening to Music is an effective tool for regulating mood and autonomic function; it also has potential as a low‐cost, safe intervention and therapeutic adjunct, The melody, tempo, volume, and other variables may have varying impacts on HRR and HRV. Consequently, finely controlling variables and conducting further research are required to accurately determine which music tempo is most effective for recovery after high‐intensity exercise; in addition, the volume and timbre of the music the length of the recovery period and intervention, and other factors may have varying effects on the autonomic nervous system. As a result, researchers in this field should continue to investigate the use of music to prevent and reduce the risk of cardiovascular incidents.
| PMC10770821 | |
INTRODUCTION | sudden cardiac death | SUDDEN CARDIAC DEATH, ACUTE MYOCARDIAL INFARCTION, AMI, CARDIAC EVENTS, HEART | According to a 2018 poll by the American College of Sports Medicine (ACSM) (American College of Sports Medicine, Cardiovascular episodes evoked by strenuous exertion can be categorized as sudden cardiac death (SCD) or acute myocardial infarction (AMI) (Maron et al., Heart rate variability (HRV) describes the variation in the time between heartbeats and is monitored by the length of two consecutive RR intervals. Heart rate recovery (HRR) and HRV are noninvasive measures that primarily represent autonomic nerve fiber control; parasympathetic nerves have been associated with the rate of recovery of vital signs after cardiac events (Fan et al., | PMC10770821 |
METHODS | PMC10770821 | |||
General information | cardiovascular ailments | A total of 500 male college students attending Yongin University, South Korea, on September 1, 2019, were randomly selected as the study population.The inclusion criteria were as follows: (1) the students were registered and enrolled in the university's student administration center as of September 1, 2019; (2) the students knowingly consented and voluntarily participated in this cohort study.The exclusion criteria were cardiovascular ailments or other illnesses that would prevent the student from undergoing strenuous, high‐intensity power cycling trials. | PMC10770821 | |
Methods and observation indexes | PMC10770821 | |||
Grouping methodology | The 500 respondents underwent anaerobic power cycling tests; on the basis of their scores, 180 students with similar scores were selected as participants and randomly divided into four subgroups: group A, the slow ( | PMC10770821 | ||
Fundamental profile collection | General demographic information (age, gender, height, weight, and body mass index [BMI]) was collected from the 180 participants using a questionnaire developed for this study. | PMC10770821 | ||
Power cycling test | The power cycling test was conducted by two professionals independently; the relevant test methods and precautions were explained to each participant before the test. Using a power bicycle (Lode, Netherlands), the participants were allowed to warm up by pedaling for 2 min. The exercise load was based on the participant's body mass (0.083 kp/kg) (Arena et al., | PMC10770821 | ||
HEART | The HRR and HRV testing was completed independently by two professionals, and the relevant test methods and precautions were explained to each participant before the test. The HRV measurement system Ubpuse T1 (Biospace, Korea) was used to measure the HRV index 0–1 min before the warm‐up. During the recovery period (0–16 min after the cycling test), the participants in all four groups listened to piano songs on a headset (Sony WH‐1000XM3, Japan) at four different speeds according to their group assignment, as shown in Table Heart rate variability index parameters. | PMC10770821 | ||
Track name and beat test | One researcher completed the track name and beat test and, according to the measurement specifications, used an electronic metronome (Seiko SP70, Japan) to test the average tempo of the piano tracks and recorded the results (see Table Track information. | PMC10770821 | ||
Participant consent and experimental setup | At the beginning of the experiment, all participants were informed of the precautions, specific test time, and test plan. To minimize the influence of external factors on the experimental results, the environment of this experiment was kept quiet. The temperature in the laboratory was maintained at 23°C, and the relative humidity was maintained at 65%; the test period was fixed, and the time at which the experiment was conducted was 15:00–17:00. Six participants were tested per day. The participants were prohibited from listening to other music, participating in vigorous exercise, eating, and drinking caffeinated beverages for 3 h before the experiment, they were asked to abstain from drinking alcohol for 48 h before the experiment. During the 0–16‐min recovery period, the track was set to a single‐track loop mode and played continuously, and the volume of the track was set to 60 decibels. The relevant experimental data were measured, recorded, and saved (Dimopoulos et al., | PMC10770821 | ||
Data entry and statistical analysis methods | high‐intensity | The data were entered and checked in two ways. For missing data, if the missing data accounted for less than 1/3 of the total data, the average of the available data was used to replace the missing data; if the missing data accounted for over 1/3 of the total data, they were omitted. The input data were sorted in Excel, and SPSS 22.0 was used for data analysis. The general data were described by frequencies and percentages, and the quantitative data with normal distributions were represented by the representation. Repeated one‐way ANOVA was performed to assess the differences in the anaerobic power cycling test indicators (HRR and HRV) between groups before and during high‐intensity exercise. Repeated two‐way ANOVA was used to assess the differences in HRR and HRV between groups during the recovery period. The hypothesis testing criterion was set to | PMC10770821 | |
RESULTS | PMC10770821 | |||
Basic information | The basic information about the participants is presented in Table Physical morphological characteristics of 173 participants (
| PMC10770821 | ||
Analysis of | No significant differences in HR and HRV were observed between the four groups (Analysis of HR and HRV indicators before exercise (
| PMC10770821 | ||
Analysis of the differences in the outcome measures of the power bicycle test during high‐intensity exercise among the four groups | high‐intensity, MP, fatigue | The absolute and relative values of average power, absolute and relative values of maximum power, fatigue index, maximum power arrival time, and total power among the four groups were not among the statistical significance (Analysis of differences in the outcome measures of the power bicycle test during high‐intensity exercise among the four groups (
Abbreviations: FI, fatigue index; MP, mean power; PP, peak power; PPI, maximum power arrival time; TW, total power. | PMC10770821 | |
Differences in the changes in the | Time‐domain | HEART | Heart rate differed significantly between the groups (Analysis of the HRR time domain variation index during the recovery period (Illustration of experimental results. Group A, Time‐domain variation index SDNN in the recovery period. | PMC10770821 |
Analysis of | The frequency domain variation indicators LFAnalysis of HRV frequency domain indicators during the recovery period (
Frequency domain indices LFFrequency domain indices HFFrequency domain indices LF/HF | PMC10770821 | ||
DISCUSSION | high‐intensity, moderato | AMI, CARDIAC EVENTS, GROUP B | Multiple studies have revealed a significant correlation between vigorous and high‐intensity exercise and the risk of SCD and AMI (Balnave et al., During and after physical exercise, HR increases sharply, parasympathetic nervous system activity decreases, and sympathetic nervous system activity increases; this elevated sympathetic activity during exercise increases the likelihood of sudden cardiac events (Perkins et al., Therefore, this study used different music speeds as interventions after intense and high‐intensity exercise. Group C (allegretto) showed superior HRR during the recovery period compared with Group B (moderato) and Group A (lento) ( | PMC10770821 |
CONCLUSIONS | high‐intensity, arrhythmia | ARRHYTHMIA | After rigorous activity, listening to allegretto transcriptions improved HRR and restored HRV equilibrium, which is critical for preventing and minimizing arrhythmia and SCD.Music is an effective tool for regulating mood and autonomic function; it also has potential as a low‐cost, safe intervention and therapeutic adjunct, The melody, tempo, volume, and other variables may have varying impacts on HRR and HRV. Consequently, finely controlling variables and conducting further research are required to accurately determine which music tempo is most effective for recovery after high‐intensity exercise; in addition, the volume and timbre of the music the length of the recovery period and intervention, and other factors may have varying effects on the autonomic nervous system. As a result, researchers in this field should continue to investigate the use of music to prevent and reduce the risk of cardiovascular incidents. | PMC10770821 |
AUTHOR CONTRIBUTIONS | Niu Mingyang and Wang Jiameng designed the experiment, Niu Mingyang and Zhao Ruixue collected the data, Wang Jiameng conducted the data analysis, Niu Mingyang and Zhao Ruixue provided experimental guidance, and Wang Jiameng and Niu Mingyang completed the manuscript writing and the revision of important content. | PMC10770821 | ||
FUNDING INFORMATION | This article was supported by the 2022 Hainan Province Philosophy and Social Science Planning Project (HNSK(QN)22‐84) and the 2021 Project supported by the Education Department of Hainan Province (project number: Hnky2021‐41). | PMC10770821 |
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