Influence of qualitative menu labeling on diners' food choices: A controlled quasi-experiment in self-service buffet restaurants.

Menu labeling is a strategy to promote healthier food choices in restaurants. This study aimed to analyze the influence of a qualitative menu labeling on the healthfulness of diners' food choices in self-service buffet restaurants. A controlled quasi-experiment comparing parallel groups at baseline and intervention periods was conducted in a control restaurant and an intervention restaurant. Qualitative labels provided information on the name and ingredients list of the dish, highlighting the use of organic vegetables. The same food menu was served in both restaurants. Menu labeling was implemented at the intervention restaurant for six dishes each day, three considered healthier and three less healthy. Dishes were weighed at the beginning and at the end of the service to estimate the average portion size (g) of diners, during five consecutive days at baseline and intervention. Diners who had lunch at the intervention restaurant were invited to participate in a survey on the use of menu labels. Of the 153 interviewed diners, 31% reported noticing menu labels. Of these, 57% said menu labeling had influenced their food choices at the restaurant. No changes in portion sizes were observed between baseline and intervention periods within control and intervention restaurants. However, it was found that the provision of qualitative menu labeling sparked the interest of restaurant managers in improving meal quality and modifying recipes to eliminate ultra-processed ingredients. Thus, the implementation of the proposed menu labeling model can promote healthier food choices through the reformulation of culinary recipes. However, it is essential to adopt strategies to enable its direct impact.

Effects of mixed nuts as part of a Brazilian Cardioprotective diet on LDL-cholesterol in adult patients after myocardial infarction: a multicenter randomized controlled clinical trial.

BACKGROUND: Nuts consumption is related to cardioprotective effects on primary cardiovascular prevention, but studies conducted in secondary prevention are small, scarce and controversial. The objective of this trial was to evaluate the effects of a regional and sustainable cardioprotective diet added or not with an affordable mixed nuts on cardiometabolic features in patients with previous myocardial infarction. METHODS: DICA-NUTS study is a national, multi-center, and superiority-parallel randomized clinical trial. Males and females over 40 years old diagnosed with previous myocardial infarction in the last 2 to 6 months were included. Patients were allocated into two groups: the Brazilian Cardioprotective diet (DICA Br) supplemented with 30 g/day of mixed nuts (10 g of peanuts; 10 g of cashew; 10 g of Brazil nuts) (intervention group, n = 193); or only DICA Br prescription (control group, n = 195). The primary outcome was low-density lipoprotein cholesterol means (in mg/dL) after 16 weeks. Secondary outcomes were other lipid biomarkers, glycemic and anthropometric data and diet quality. RESULTS: After adjustment for baseline values, participating study site, time since myocardial infarction and statin treatment regimen (high potency, moderate and low potency/no statins), no significant difference was found between the groups in low-density lipoprotein cholesterol concentrations (intervention-control difference: 3.48 mg/dL [-3.45 to 10.41], P = 0.32). Both groups improved their overall diet quality at the end of the study without differences between them after 16 weeks (intervention-control difference: 1.05 (-0.9 to 2.99); P = 0.29). Other lipids, glycemic profile and anthropometrics were also not different between study groups at the end of the study. CONCLUSION: Adding 30 g/day of mixed nuts to the DICA Br for 16 weeks did not change lipid, glycemic and anthropometric features in the post-myocardial infarction setting. TRIAL REGISTRATION: This study is registered on ClinicalTrials.gov website under number NCT03728127 and its World Health Organization Universal Trial Number (WHO-UTN) is U1111-1259-8105.

Assessing a Couples-Based, Digital HIV Serostatus-Neutral Intervention (Para Ti, Para Mí, Para Nosotros) for Adult Cisgender Sexual Minority Male Couples in Lima, Peru: Protocol for a 6-Month Pilot Randomized Controlled Trial.

BACKGROUND: HIV disproportionately affects sexual minority men (SMM; eg, gay, bisexual, and other men who have sex with men) in Lima, Peru; epidemiological data estimate that 32% to 39% of new HIV infections occur among adult cisgender SMM within primary partnerships (ie, male couples). Most HIV prevention-care research in Lima, Peru, has focused on SMM as individuals and not couples. To help address this critical gap in prevention care, we developed Para Ti, Para Mí, Para Nosotros (P3): a couples-based, digital HIV serostatus-neutral intervention (DHI) for adult cisgender SMM couples in Lima, Peru. The P3 DHI is designed to facilitate couples with skill-building, communication, decision-making, and working together to form and adhere to a detailed prevention care plan that aligns with their explicit sexual agreement. The P3 DHI is theoretically informed, self-guided, directed, sequential, and fully automated. OBJECTIVE: This pilot randomized controlled trial (RCT) aims to examine the preliminary effects of P3 on couples' formation and adherence to a detailed prevention care plan containing evidence-based strategies that also aligns with their explicit sexual agreement over time. In addition, the feasibility of enrollment and retention and couples' acceptability of P3 will be assessed. METHODS: The research implements a prospective, 6-month pilot RCT with a 3-month delayed control condition. After baseline, 60 enrolled SMM couples will be randomized to 1 of 2 conditions. Couples randomized to the unmatched, delayed control condition will receive access to the P3 DHI to use during the last 3 months of the trial after the 3-month assessment. Couples randomized to the immediate intervention condition will immediately receive access to the P3 DHI for 6 months. Study assessments will occur at baseline and months 3 and 6. Descriptive, comparative, qualitative, and longitudinal analyses using generalized linear mixed-effect, multilevel, and actor-partner interdependence models will be conducted to address the specific aims. RESULTS: The 6-month pilot RCT is ongoing. Recruitment, enrollment, and data collection began in January 2023 and ended in April 2024. A total of 74 adult cisgender SMM couples met all inclusion criteria, provided consent, and were enrolled in the pilot RCT. Retention was 92% (68/74) at month 6. Data are currently being analyzed to address the 3 specific aims regarding feasibility, acceptability, and preliminary efficacy. CONCLUSIONS: Findings from this research will reveal whether couples deemed the P3 DHI to be acceptable. Findings will also highlight the preliminary efficacy of the P3 DHI on couples managing their vulnerability to HIV and other sexually transmitted infections (STIs) over time via alignment of their prevention-care plan and sexual agreement. Trial findings will help shape the future direction of the P3 DHI while addressing the existing gap in prevention and care services for couples in the local context. TRIAL REGISTRATION: ClinicalTrials.gov NCT05873855; https://clinicaltrials.gov/study/NCT05873855. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/63106.

Articulated ankle-foot orthoses associated with home-based task-specific training improve functional mobility in patients with stroke: a randomized clinical trial.

INTRODUCTION: We compared fixed and articulated ankle-foot orthoses (AFOs) in home-based mobility tasks to assess short-term mobility, dynamic balance, quality of life, anxiety/depression, disability level, stroke severity, autonomy, human functioning, and patient satisfaction. METHODS: This was a two-arm, parallel-group, randomized controlled trial with concealed allocation, assessor blinding, and a complete case analysis involving patients with chronic stroke. The participants were randomized into two groups: fixed (n = 24) and articulated (n = 23) AFOs. The AFOs were custom-fabricated, and both groups performed four-week home-based mobility tasks five days weekly. Primary outcome measures included changes in balance and mobility assessed using the Tinetti Performance-Oriented Mobility Assessment (POMA), Timed Up and Go (TUG) test, and Functional Ambulation Category (FAC). Secondary outcomes included quality of life, anxiety/depression, disability, stroke severity, autonomy, human functioning, and patient satisfaction. RESULTS: In a between-group comparison, after adjusting for age, sex, stroke severity, and thrombolysis, the articulated AFO group showed better performance in the TUG test (p = 0.020; d = 0.93), POMA-Gait (p = 0.001; d = 0.53), POMA-Total (p = 0.048; d = 0.98), and FAC (p = 0.003; d = 1.03) than the fixed AFO group. Moreover, significant difference was noted in human functioning (moving around using equipment)between the groups (p = 0.047; d = 92). CONCLUSION: A program involving home-based mobility tasks and articulated AFOs improved functional mobility after stroke.

Mindfulness and compassion-based programs on eating behavior of post-bariatric surgery patients: A two phased clinical trial protocol.

INTRODUCTION: Weight regain after bariatric surgery remains a relevant and worrisome topic, requiring greater understanding and involvement in research into new adjuvant treatments. This study aims to compare the preliminary effectiveness and feasibility of the Mindfulness-Based Health Promotion and Attachment-Based Compassion Therapy programs as opposed to usual treatments (workshops) on the eating behavior of patients with progressive weight gain after bariatric surgery in Brazilian patients at a private clinic. It was hypothesized that both interventions are feasible and that the self-compassion program may be more effective than the mindfulness program. METHODS: The study will be divided into two phases: a cross-analytical study of those who underwent bariatric surgery and a randomized controlled trial only with the ones who had weight regain. Interventions will be conducted for eight weeks synchronously with three assessment points (baseline, post intervention, and 6-month follow-up), both online. The primary outcome will be a change in eating behavior. Secondary outcomes will include improved quality of life, enhanced body image satisfaction and reduced distortion (Brazilian Silhouette Scales for adults), better weight management (maintenance or weight reduction), increased frequency of activity and monitoring with the surgery team. Qualitative data will also be collected by online identification of a sub-sample of participants. RESULTS: Improvements are expected in eating behavior, weight, reverse progressive weight gain, classification of self-image, quality of life, and levels of mindfulness, self-compassion, and anxiety. CONCLUSION: This study seeks to gather preliminary evidence on the effectiveness of mindfulness and compassion training for the adjunctive treatment of progressive weight gain in post-bariatric patients. Clinical Trials.gov Registration ID: NCT04171713.

The efficacy of Botulinum Toxin in Tennis Elbow: a meta-analysis of randomized clinical trials.

PURPOSE: This study aims to assess the efficacy of botulinum toxin type A (BT-A) in treating tennis elbow. METHODS: We systematically reviewed the literature and included full-text randomized clinical trials (RCTs) published until June 2024, available in PubMed, Scopus, Embase, and Cochrane CENTRAL databases. Eligible studies involved patients with tennis elbow and compared BT-A with placebo or other injectable treatments. Primary outcomes included pain relief, while secondary outcomes assessed quality of life, adverse effects, and grip strength. The risk of bias was evaluated using the Cochrane Risk of Bias tool. RESULTS: Seven RCTs with a total of 381 patients were included. The participants were predominantly middle-aged (mean age 46.64 ± 7.72 years) and diagnosed with chronic tennis elbow. BT-A doses ranged from 20U to 60U. Compared to placebo, BT-A effectively reduced pain at two to four weeks (MD = -1.37; 95% CI = -2.18 to -0.57) and at eight to 12 weeks (MD = -1.13; 95% CI = -1.62 to -0.65). Grip strength was comparable between the BT-A and placebo groups at both time points (2 to 4 weeks: SMD = -0.86; 95% CI -1.78 to 0.05; 8 to 12 weeks: SMD = 0.00; 95% CI = -0.95 to 0.95). CONCLUSION: This meta-analysis suggests that BT-A reduces pain in tennis elbow within two to 12 weeks compared to placebo. Findings are limited by study size, and further research is needed to confirm its efficacy and safety.

Effects of photobiomodulation therapy associated with motor control exercise for chronic non-specific low back pain: protocol for a randomised placebo-controlled trial.

Photobiomodulation therapy (PBMT), as an adjunct therapy to exercise, can reduce pain in musculoskeletal disorders. In addition, PBMT associated with exercise decreases fatigue, accelerates muscle recovery and enhances performance and gain through different training protocols. Although it has not been investigated, the association of PBMT and exercise therapy could be an alternative to improve the positive effects of exercise in patients with non-specific low back pain (LBP). Therefore, we aim to evaluate the effects of PBMT associated with motor control exercise (MCE) versus placebo associated with MCE in patients with chronic non-specific LBP. This is a prospectively registered, two-arm, randomised, placebo-controlled, triple-blind trial. A total of 148 patients with chronic non-specific LBP will be randomised to either active PBMT associated with MCE or placebo PBMT associated with MCE. Treatment sessions will be provided twice a week for 6 weeks. The primary outcomes will be pain intensity and general disability measured at the end of the treatment. The secondary outcomes will be pain intensity and general disability measured 1 month after the end of the treatment, 3, 6 and 12 months after randomisation, in addition to levels of prostaglandin E2 measured at the end of the treatment. Medication intake, cointerventions and adverse events will be measured at all time points. This study was approved by the Research Ethics Committee of Irmandade de Santa Casa de Misericórdia de Porto Alegre. The results will be disseminated through scientific publications and presentations at scientific meetings. Trial registration number: NCT05487118.

A case management strategy to reduce falls in older people with a history of falls: A randomized controlled trial.

The present study aimed to determine whether a remotely delivered intervention, based on an individual case management, can reduce falls and their consequences in community-dwelling older people with a history of multiple falls. In this randomized controlled trial, 32 participants were randomized to the intervention group, which comprised a 16-week case management program involving a multidimensional assessment, targeted interventions according to the identified fall risk factors, and development of individualized care plans. The intervention was performed by trained gerontologists, under weekly supervision of professionals with experience in falls. The control group (n = 30) received usual care. Falls were monitored over 12 months with monthly falls calendars and telephone calls. Remotely delivered case management presented an 82 % uptake of recommendations. There was a trend toward a reduced fall incidence in the intervention vs control group, with lower fall, fall injury and fracture rates in the intervention group compared with the control group at both the 16-week and 12-month time-points, with the difference statistically significant for injurious fall rates at 12 months - IRR=0.18 (95 % CI = 0.04 to 0.74).

BCG vaccination of healthcare workers for protection against COVID-19: 12-month outcomes from an international randomised controlled trial.

OBJECTIVES: Bacille Calmette-Guérin (BCG) vaccine has immunomodulatory effects that may provide protection against unrelated infectious diseases. We aimed to determine whether BCG vaccination protects adults against COVID-19. DESIGN: Phase III double-blind randomised controlled trial. SETTING: Healthcare centres in Australia, Brazil, the Netherlands, Spain, and the United Kingdom during the COVID-19 pandemic. PARTICIPANTS: 3988 healthcare workers with no prior COVID-19 and no contraindication to BCG. INTERVENTION: Randomised 1:1 using a web-based procedure to receive a single 0.1 mL intradermal dose of BCG-Denmark (BCG group, n = 1999) or saline (placebo group, n = 1989). MAIN OUTCOME MEASURES: Difference in incidence of (i) symptomatic and (ii) severe COVID-19 during the 12 months following randomisation in the modified intention to treat (mITT) population (confirmed SARS-CoV-2 naïve at inclusion). RESULTS: Of the 3988 participants randomised, 3386 had a negative baseline SARS-CoV-2 test and were included in the mITT population. The 12-month adjusted estimated risk of symptomatic COVID-19 was higher in the BCG group (22.6%; 95% confidence interval [CI] 20.6 to 24.5%) compared with the placebo group (19.6%; 95% CI 17.6 to 21.5%); adjusted difference +3.0% points (95% CI 0.2 to 5.8%; p = 0.04). The 12-month adjusted estimated risk of severe COVID-19 (mainly comprising those reporting being unable to work for ≥3 consecutive days) was 11.0% in the BCG group (95% CI 9.5 to 12.4%) compared with 9.6% in the placebo group (95% CI 8.3 to 11.1%); adjusted difference +1.3% points (95% CI -0.7 to 3.3%, p = 0.2). Breakthrough COVID-19 (post COVID-19 vaccination) and asymptomatic SARS-CoV-2 infections were similar in the two groups. There were 18 hospitalisations due to COVID-19 (11 in BCG group, 7 in placebo group; adjusted hazard ratio 1.56, 95% CI 0.60 to 4.02, p = 0.4) and two deaths due to COVID-19, both in the placebo group. CONCLUSIONS: Compared to placebo, vaccination with BCG-Denmark increased the risk of symptomatic COVID-19 over 12 months among healthcare workers and did not decrease the risk of severe COVID-19 or post-vaccination breakthrough COVID-19. TRIAL REGISTRATION: ClinicalTrials.gov NCT04327206.

Color Stability of Single-Shade Resin Composites in Direct Restorations: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

The objective was to compare the color match and color stability behavior of single- and multi-shade resin-based composites (RBCs) used for direct restorations. This review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Randomized clinical trials evaluating the shade performance of single-shade RBCs in direct restorations were included. A search of the scientific literature was performed in five databases (April 2024). The meta-analysis was performed using RevMan 5.4, calculating the risk difference (RD) and 95% confidence interval (CI) of the dichotomous outcome using a random effects model. Bias was assessed using the RoB 2.0 tool, and certainty of evidence was assessed using the GRADEpro tool. Four studies were selected, with 263 restorations analyzed. The results showed comparable performance between single-shade RBCs and multi-shade RBCs in terms of color match and color stability over 12 months. Three studies had a low risk of bias with all expected results, and one study had some concerns. The certainty of evidence for color stability was considered low for all follow-up periods due to the small number of events and sample size. According to the United States Public Health Service Evaluation (USPHS) and the World Dental Federation (FDI), there is comparable clinical color performance between single-shade and multi-shade RBCs over 12 months.

Effects of respiratory muscular training in post-covid-19 patients: a systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Post-Covid-19 syndrome is defined as non-self-sustaining signs and/or symptoms lasting more than 12 weeks, occurring during or after a Covid-19 infection. The primary outcome was the analysis of the respiratory muscle training (RMT) result in respiratory muscle strength, (maximum inspiratory pressure (MIP) e maximum expiratory pressure (MEP)); and the secondary results were the analysis of lung function, dyspnea, quality of life (QoL), fatigue and functional performance. METHODS: The PICO description for this research was: P: patients diagnosed with post-Covid-19; I: RMT; C: Sham or simulated inspiratory or expiratory muscle training and usual care; O: MIP, MEP, Lung Function, level of dyspnea, QoL and functional performance. On January 15, 2024, the following databases were consulted: PubMed, Lilacs, Cochrane Library, PEDro and EMBASE. Randomized clinical trials were included without restrictions on year of publication or language. The data selection and extraction steps were carried out by two independent reviewers. RESULTS: The search in the databases resulted in a total of 14,216 studies, and after the eligibility process, 7 studies were included with a sample of 527 patients. The MIP results suffered a statistically significant increase, that is, the RMT was favorable to improve the MIP (MD = 29.55cmH2O IC 95%: 7.56cmH2O to 51.54cmH2O, p = 0,00001). For the MEP outcome, the results were statistically significant in favor of RMT (MD = 10.93cmH2O CI 95%: 3.65cmH2O to 18.21cmH2O, p = 0.00001). We also noticed a significant improvement for the group that received the RMT in the distance covered in the 6-Minute Walk Test (6MWT) MD = 40.70 m CI 95%: 18.23 m to 65.17 m%, p = 0.01). CONCLUSION: We noticed that RMT is being used in patients with respiratory diseases, including post-Covid-19. Our systematic review observed that this training provides an increase in inspiratory and expiratory muscle strength, a reduction in dyspnea levels, and an increase in the distance covered in the 6MWT and improved QoL in post-covid patients after intervention.

Assessing transparency practices in dental randomized controlled trials.

BACKGROUND: To evaluate transparency practices in randomized controlled trials (RCTs) in dentistry. METHODS: This meta-research study included RCTs in dentistry regardless of topic, methods, or level of detail reported. Only studies in English were considered. We searched PubMed for RCTs in dentistry published in English from December 31, 2016, to December 31, 2021. The screening was performed in duplicate, and data extracted included journal and author details, dental specialty, protocol registration, data and code sharing, conflict of interest declaration, and funding information. A descriptive analysis of the data was performed. We generated maps illustrating the reporting of transparency items by country of the corresponding author and a heat table reflecting reporting levels by dental specialty. RESULTS: A total of 844 RCTs were included. Only 12.86% of studies reported any information about data and code sharing. Protocol registration was reported for 50.36% of RCTs. Conflict of interest (83.41%) and funding (71.68%) declarations were present in most studies. Conflicts of interest and funding were consistently reported regardless of country or specialty, while data and code sharing had a low level of reporting across specialties, as well as low dissemination across the world. Protocol registration exhibited considerable variability. CONCLUSIONS: Considering the importance of RCTs for evidence-based dentistry, it is crucial that everyone who participates in the scientific production and dissemination process actively and consistently promotes adherence to transparent scientific standards, particularly registration of protocols, and sharing of data and code.

Effects of computer-based cognitive training vs. paper-and-pencil-based training on the cognitive development of typically developing children: Protocol for a randomized controlled trial.

The research aims to evaluate the effectiveness of a computerized cognitive training program in improving executive functions and attention in elementary school children, compared to a traditional paper-and-pencil intervention. The study has been formulated as a randomized controlled trial with pre- and post-intervention measures. For the study, third-grade children with typical development aged between 7 and 9 years will be recruited. Participants will be randomly assigned to the two study arms (control and experimental). The experimental group will participate in a computerized intervention using the NeuronUp cognitive stimulation platform for 8 weeks, twice a week. Sessions will be conducted using computers in the computer lab of the participating educational institution. The active control group will engage in paper-and-pencil cognitive training for the same duration and intensity as the experimental group. Evaluators will be blinded to the assignment, and participants will be blinded to the target intervention. Hypothesis testing will be conducted through ANOVA-MR, and logistic regressions will be implemented to assess the effect of socioeconomic variables on children's performance. These results are expected to contribute to the discussion on the opportunities and benefits offered by cognitive training programs on the cognitive development of typically developing children.

Significance of phosphoinositide 3-kinase inhibitors in advanced breast cancer: a systematic review and meta-analysis.

BACKGROUND: The Phosphoinositide 3-kinase (PI3K) inhibitors may be used in cancer progression and mortality along with standard therapy to improve therapeutic efficacy of Advanced Breast Cancer (ABC). PURPOSE: This systematic review and meta- analysis were conducted to understand the therapeutic and toxicity profile of PI3K inhibitors in ABC. METHODS: The electronic databases were searched for suitable trials as per the criteria. The outcomes assessed were Progression- Free Survival, Objective Response Rate and Disease Control Rate. The data were systematically reviewed and meta-analyzed by Mantele- Haenszel method. RESULTS: Seven studies were included in the systematic review and meta- analysis. The co- administration of PI3K inhibitors with standard therapy improved the Progression- Free Survival significantly, while a marginal improvement was observed in Objective Response Rate, no difference in Disease Control Rate and toxicity significantly increased. CONCLUSIONS: The addition of PI3K inhibitors decreased the risk of progression but increased the risk of toxicity.

School-based intervention for anxiety using group cognitive behavior therapy in Pakistan: a feasibility randomized controlled trial.

BACKGROUND: Anxiety and mood disorders are the main cause of illness in people under the age of 25, accounting for 45% of the global disease burden, whereas 4.6% of teenagers aged 15 to 19 are predicted to experience anxiety. Pakistan country, with a population of 200 million, has the worst mental health indicators and fewer than 500 psychiatrists. Despite the existence of various treatments for anxiety, this goes unrecognized and untreated. Due to a lack of awareness, evaluation, prevention, and interventional programs related to being implemented among adolescents in Pakistan, there is a rise in mental health issues in the earlier years of life. It calls for a critical need for indigenous, evidence-based interventions. The present study aimed to evaluate the feasibility of cognitive behavioral therapy (CBT)-based interventions to reduce anxiety symptoms among school children in Pakistan. METHODS: This study was a pre-post design, two-arm, single-blinded, feasibility, randomized controlled trial. Thirty-four participants (experimental group, n = 17; control group, n = 17) were recruited from four semi-government schools in Rawalpindi with a mean age of 15 (M = 15, SD = 0.73). Two instruments Beck Anxiety Inventory for Youth (BAI-Y II) and BASC-3 Behavioural and Emotional Screening System Student (BESS-SF) were used to assess the severity of symptoms. Participants in the intervention arm received eight-group therapy CBT sessions. A two-way factorial analysis was used to examine the efficacy of CBT in reducing symptom severity. RESULTS: This study's findings showed that in comparison to the wait-list control group, CBT successfully improved anxiety symptoms among school children while enhancing their social skills. CONCLUSION: This study will help improve the treatment for anxiety in Pakistan by prioritizing school-based intervention and group-based CBT intervention. TRIAL REGISTRATION: The trial has been registered at the American Economic Association's registry for randomized controlled trials. RCT ID: AEARCTR-0009551 . Registered 2022-07-04.

Effectiveness of Resistance Training Program on Body Composition in Adults Following Vegan Diet versus Omnivorous Diet; Developed in Mobile Health Modality.

BACKGROUND: The vegan diet (VEGD) has gained popularity in recent years for ecological and ethical reasons, as well as for its health benefits. In addition to the type of diet, the resistance training program (RTP) plays a fundamental role as one of the main natural anabolic stimuli to increase musculoskeletal mass and reduce fat mass. METHODS: The study was a 16-week non-randomized controlled clinical trial consisting of three RTP sessions per week. The sample included 70 Chilean individuals, aged between 18 and 59 years, who had been following a VEGD or omnivorous diet (OMND) for the past 6 months. Four groups were established: Vegan Diet Resistance Training Program (VEGD-RTP), Vegan Diet Control (VEGD-C), Omnivorous Diet Resistance Training Program (OMND-RTP), and Omnivorous Diet Control (OMND-C). RESULTS: The sample consisted of 47 women and 23 men, with a mean age of 30.1 (±8.6) years. A reduction of 1.20% in the percentage of fat mass (%FM) was observed in the VEGD-RTP group (r = 0.554, p = 0.016), as well as a reduction of 0.70 kg in kilograms of fat mass (KFM) (r = 0.480, p = 0.036). The OMND-RTP group decreased %FM by 0.90% (r = 0.210, p = 0.432) and KFM by 0.50 kg (r = 0.109, p = 0.683). CONCLUSIONS: RTP combined with VEGD or OMND significantly reduced the percentage of fat mass, although its effect was more significant in the VEGD-RTP participants.

Effects of bottom-up versus top-down digital cognitive training in older adults: A randomized controlled trial.

INTRODUCTION: Impairments in bottom-up perceptual processing have been associated to the age-related cognitive decline. Digital cognitive training focusing on bottom-up and/or top-down processes have been studied as a tool to remediate age-related cognitive decline. However, the most effective training type and order of application remain unclear. METHODS: One hundred and fifteen older adults were randomly assigned to 40 h of bottom-up then top-down or top-down then bottom-up digital cognitive training or an active control group. We evaluated cognition at baseline, after 20 h and 40 h of training and at follow-up using a mixed-model analysis. RESULTS: Global cognition improved, for the top-down group, after 20 h of training (p = 0.04; d = 0.7) and for all three groups after 40 h. The improvement in global cognition remained five months after the bottom-up/ top-down training (p = 0.009; d = 4.0). There were also improvements in the recall cognitive domain, after 20 h of training, for the bottom-up group and, after 40 h, for all three groups. Gains were observed in verbal fluency after 40 h of training for both therapeutic groups. Processing speed was significantly slower, after 20 h of training, for the control and bottom-up groups and, after 40 h, only for the control group. Emotion recognition improved, after 20 h, for the control group as compared to the therapeutic groups. CONCLUSIONS: These results indicate that the bottom-up/top-down training has the most endurable effects, which reveals the importance of the order of application of the exercises for gains in cognition in older adults.

Effect of Green Tea Supplementation on Inflammatory Markers among Patients with Metabolic Syndrome and Related Disorders: A Systematic Review and Meta-Analysis.

Several randomized controlled trials (RCTs) have investigated the potential benefits of green tea on the inflammatory process in metabolic syndrome (MetS). However, the results are inconclusive and inconsistent. In the present study, we performed a literature review and meta-analysis to evaluate the effect of green tea supplementation on inflammatory markers [e.g., tumor necrosis factor-α (TNF-α), C-reactive protein (CRP), and interleukin-6 (IL-6)] among patients with MetS and related disorders. We systematically searched for relevant publications up to March 2022 in the PubMed, Scopus, Web of Science, and SciELO databases. The review was registered with PROSPERO (CRD42022320345). Mean differences with 95% confidence intervals were pooled on the basis of the random effects model to compare the effects of green tea with placebo. We used meta-regression and subgroup analyses to determine the cause of heterogeneity and performed study quality assessment using the Grading of Recommendations Assessment, Development, and Evaluation method. We assessed publication bias using funnel plots and Egger's tests. Out of the total 15 RCTs that were included in this systematic review, 12 were chosen for the meta-analysis. The results revealed that green tea significantly decreased TNF-α levels but did not affect CRP and IL-6 levels. Subgroup analysis showed that green tea supplementation in studies lasting ≤8 weeks significantly increased CRP levels. Furthermore, meta-regression analysis demonstrated a significant association between increasing IL-6 concentration and treatment duration. According to our meta-analysis, green tea was shown to considerably lower circulating TNF-α levels. To confirm these findings, carefully planned trials are required.

Acute Effect of Transcranial Direct Current Stimulation in Pelvic Floor Muscle Function in Young Healthy Women: Initial Findings of a Randomized Controlled Trial.

INTRODUCTION AND HYPOTHESIS: Transcranial direct current stimulation (tDCS) can enhance muscle function in healthy individuals. However, it is unknown if tDCS associated with pelvic floor muscle training (PFMT) can improve pelvic floor muscle function (PFMF) in healthy women. The aim of this study was to investigate the acute effect of a single session of tDCS in PFMF compared with sham-tDCS in healthy women. METHODS: A double-blind, cross-over, randomized clinical trial was conducted with healthy, nulliparous and sexually active women. PFMF was assessed by bidigital palpation (PERFECT scale) and intravaginal pressure by a manometer (Peritron™). Participants randomly underwent two tDCS sessions (active and sham) 7 days apart. The electrode was positioned equal for both protocols, the anode electrode in the supplementary motor area (M1) and the cathode electrode in the right supraorbital frontal cortex (Fp2). The current was applied for 20 min at 2 mA in active stimulation and for 30 s in sham-tDCS. The tDCS applications were associated with verbal instructions to PFMT in a seated position. After each tDCS session PFMF was reevaluated. RESULTS: Twenty young healthy women (aged 23.4 ± 1.7 years; body mass index 21.7 ± 2.2 kg/m2) were included. No difference was observed in power, endurance, and intravaginal pressure of PFMF (p > 0.05). The number of sustained contractions improved from 3.0 (2.0-3.5) to 4.0 (3.0-5.0) after active-tDCS (p = 0.0004) and was superior to sham-tDCS (p = 0.01). CONCLUSION: The number of sustained contractions of PFM improved immediately after a single active-tDCS session, with a difference compared with the post-intervention result of sham-tDCS in healthy young women.

PROMRIINE (PRe-operatory Magnetic Resonance Imaging is INEffective) Study: A Systematic Review and Meta-analysis of the Impact of Magnetic Resonance Imaging on Surgical Decisions and Clinical Outcomes in Women with Breast Cancer.

BACKGROUND: The purpose of this study was to review and summarize the association between preoperative magnetic resonance imaging (MRI) and surgical outcomes in women with newly diagnosed invasive breast cancer from published randomized controlled trials (RCT). MATERIALS AND METHODS: Two independent researchers conducted a systematic review through a comprehensive search of electronic databases, including PubMed, Medline, Embase, Ovid, Cochrane Library, and Web of Science. If there was disagreement between the two reviewers, a third reviewer assessed the manuscript to determine whether it should be included for data extraction. The quality of the papers was assessed using the risk of bias tool, and the evidence was analyzed using GRADE. Meta-analyses using a fixed-effects model were used to estimate the pooled risk ratio (RR) and 95% confidence interval (CI). RESULTS: Initially, 21 studies were identified, 15 of which were observational comparative studies. A total of five RCTs were included, and they suggested that preoperative MRI significantly reduced the rate of immediate breast-conserving surgery and increased the risk for mastectomy. CONCLUSIONS: From the RCT perspective, preoperative MRI for newly diagnosed invasive breast cancer did not improve surgical outcomes and may increase the risk of mastectomy.