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Ethics statement | This study was conducted in accordance with the Declaration of Helsinki [CONSORT diagram | PMC10074366 | ||
Subject recruitment | The study was registered in ClinicalTrials.gov (reg #: NCT04366544) on 29/04/2020. Subjects for this non-randomized parallel controlled study were recruited from the same participant pool as a previously published study [Demographic data | PMC10074366 | ||
Samyama program – preparatory process | PMC10074366 | |||
Dietary requirements | As part of the Samyama preparatory process (60 days before the program), Samyama participants (meditators) followed a vegan diet with at least 50% raw foods consumed. Additionally, they were requested to avoid dietary intake of garlic, onion, chili, eggplant, | PMC10074366 | ||
Meditation practice requirements | Samyama participants (meditators) were required to take several prerequisite meditation programs before enrolling in Samyama. These included Inner Engineering [ | PMC10074366 | ||
Samyama program – retreat | During the program, meditators were to remain silent for the entire 8-day duration of the program. They took part in all-day meditation sessions with intermittent breaks. The program hall was closed to external influences. No specific instructions or programs were given to the controls. Upon completing the Samyama prog... | PMC10074366 | ||
Stool sampling | STERILE, COLD | Subjects were requested to submit stool samples for 3 time points – 2 months before Samyama (T1), immediately before Samyama (T2), and 3 months following Samyama (T3). Stool samples were collected from meditators and control subjects in sterile fecal collection containers. Upon receiving samples from participants, they... | PMC10074366 | |
Metabolomics | Metabolomics were performed as described previously [Metabolite data was analyzed by El-MAVEN software package and identified by matching observed m/z signals (± 10 ppm) and chromatographic retention times to those observed from commercial metabolite standards (Sigma-Aldrich) [ | PMC10074366 | ||
Microbiota composition and data analysis | We used 16 s rRNA sequencing to study the participants' microbiome over time. Sequencing data from MiSeq was de-multiplexed and converted to FASTQ format using Illumina's bcl2fastq (RRID:SCR_015058) software. CutAdapt was used for initial quality trimming [ | PMC10074366 | ||
Results | PMC10074366 | |||
Demographic data | ± | There were 265 meditators enrolled in this study, including 139 females and 126 males with an average age of 40.7 ± 10.9 years, and 23 house-hold controls including 10 females and 13 males with an average age of 42 ± 1.41. Participants’ demographic data is summarized in Table | PMC10074366 | |
Microbial diversity | Figure Charts show phylum level relative abundance profile for meditators and controls at 3-time pointsPhylum level relative abundance values for timepoints and typesAlpha diversity plots Beta diversity plots. PCoA was used to visualize the Bray–Curtis similarity for all participants over time | PMC10074366 | ||
Differential abundance analysis | To pinpoint the differences in the microbiota (genus level) we conducted differential abundance analysis over time in participants. We did not find any significantly different taxa in control samples over time (data not shown); hence we focused here on meditators only. Among meditators, Taxa enrichment genus level resu... | PMC10074366 | ||
Short-chain fatty acid levels | We further investigated short chain fatty acid (SCFA) levels in participants over time. While we did not find differences over time in the proportions of SCFAs ascribed to carbohydrate metabolism (butyrate, acetate and propionate), we found that within meditators, branched SCFAs including iso-butyrate (Fig. SCFA showed... | PMC10074366 | ||
Other metabolites’ profiling | We also explored the changes in other microbial-derived metabolites over time in the participants (untargeted metabolomics analysis). While we did not find any metabolites to be significantly different in control participants over time, we found 46 metabolites to be significantly different in meditators overtime points... | PMC10074366 | ||
Conclusion | This non-randomized controlled longitudinal prospective study is among the first and largest to explore the gut microbiome and metabolome profile after an advanced Samyama meditation program delivered with a vegan diet. First, we observed changes in meditator beta diversity after Samyama. Additionally, after the prepar... | PMC10074366 | ||
Acknowledgements | The authors appreciate support provided by Isha Institute of Inner Sciences, McMinnville, TN and study volunteers for this prospective research on Samyama participants. | PMC10074366 | ||
Authors’ contributions | RECRUITMENT | MR contributed to manuscript preparation, analysis, and experimental design. RV contributed to manuscript preparation and experimental design. HR contributed to analysis and manuscript preparation. MG and AS contributed to manuscript preparation. DP contributed to design and recruitment. BS and SS contributed to manusc... | PMC10074366 | |
Funding | This research was funded by Indiana University, Indianapolis, IN. | PMC10074366 | ||
Availability of data and materials | The data is available in from the United States National Library of Medicine and the National Center for Biotechnology Information. The BioProject is 904395 ( | PMC10074366 | ||
Declarations | PMC10074366 | |||
Ethics approval and consent to participate | This study was conducted in accordance with the Declaration of Helsinki (28). It was reviewed and approved by the Indiana University School of Medicine Internal Review Board (IRB) (#1801728792). Subjects provided electronic informed consent for this study after completing initial electronic surveys. | PMC10074366 | ||
Consent for publication | Not applicable. | PMC10074366 | ||
Competing interests | The authors declare no competing interests. | PMC10074366 | ||
References | PMC10074366 | |||
1. Introduction | ±, RET, muscle contraction | CONTRACTION | Choline plays many important roles, including the synthesis of acetylcholine, and may affect muscle responses to exercise. We previously observed correlations between low choline intake and reduced gains in strength and lean mass following a 12-week resistance exercise training (RET) program for older adults. To furthe... | PMC10534351 |
2. Materials and Methods | PMC10534351 | |||
2.1. Participants | RET, cancer, hernia, diabetes, lung disease, hypertension | CARDIAC ARRHYTHMIAS, KIDNEY DISEASE, CANCER, AORTIC ANEURYSM, HYPERTENSION | Thirty-seven generally healthy 50-to-69-year-old males and females were recruited via flyers and advertisements in a local newspaper. Smokers and individuals with any of the following health conditions were excluded: hypertension (>160/100 mmHg), cardiac arrhythmias, cancer, hernia, aortic aneurysm, kidney disease, dia... | PMC10534351 |
2.2. Orientation | During two weeks of a pre-study orientation period, the participants attended two sessions of nutrition education by a registered dietitian and four sessions of exercise orientation/familiarization ( | PMC10534351 | ||
2.3. Testing | RET | CHOLINE DEFICIENCY | Following the orientation, 1RM, peak power, body composition, resting metabolic rate (RMR), and blood tests were conducted. The 1RMs for all the exercises included in the RET program were measured by gradually increasing exercise weights until the maximum resistance, at which only one repetition was completed with prop... | PMC10534351 |
2.4. RET | HEART | Based on the recommendations from ACSM and American Heart Association (AHA) [ | PMC10534351 | |
2.5. Nutrition Control | Participants were instructed to consume 50% of total calories from carbohydrates, 30% from fat, 20% from protein, and <10% from saturated fat to meet daily caloric consumption goals, as determined by RMR test. They were also instructed to consume >1.0 g/kg/d of protein, 25–30 g/d of fiber, and <200 mg/d of cholesterol,... | PMC10534351 | ||
2.6. Thigh-Muscle Quality | From the DEXA scans of each participant, thigh-muscle quality–strength (TMQ-S) was assessed and defined as leg press 1RM (kg)/total thigh lean mass for both lower limbs (kg). Total thigh lean mass was determined through the construction of a four-sided polygon encompassing the entire region of each thigh and combining ... | PMC10534351 | ||
2.7. Data Analysis | RET | REGRESSION | All statistical analyses were conducted using SAS/STAT software (version 9.4; SAS Institute Inc., Cary, NC, USA). The mean intakes of all nutrients were calculated from the diet logs that were entered into NutriBase software (version 7, Cybersoft Inc., Phoenix, AZ, USA) or direct calculations from the USDA database for... | PMC10534351 |
3. Results | PMC10534351 | |||
3.1. Demographics | RET | The baseline characteristics of the 37 participants who completed the 12 weeks of RET are presented in | PMC10534351 | |
3.2. Nutritional Compliance | Participants successfully followed the dietary guidelines of the study and met all the requirements for nutritional intake. On average, the participants consumed 27 kcal/kg/d of energy, 3.2 g/kg/d of carbohydrate, 1.4 g/kg/d of protein, and 1.0 g/kg/d of fat throughout the study, and there was no difference in nutrient... | PMC10534351 | ||
3.3. RET Responses | RET | REGRESSION | RET resulted in significant increases in lean mass and strength from baseline in all three groups while only low and med groups lost significant body fat (Because there was no difference between males and females in muscle responses to RET (male vs. female; percent change in lean mass: 3.6 ± 2.0 vs. 3.6 ± 3.6, Because ... | PMC10534351 |
3.4. Blood Lipids and Liver Damage Markers | liver damage, muscle damage | LIVER DAMAGE, CHOLINE DEFICIENCY | Since choline deficiency causes liver/muscle damage and altered lipoprotein/blood lipid metabolism, blood markers for liver damage (alanine aminotransferase (ALT) and aspartate aminotransferase (AST)), muscle damage (creatine kinase (CK)), and blood lipid profiles (triacylglycerol (TAG), total cholesterol, high-density... | PMC10534351 |
4. Discussion | RET | CHOLINE DEFICIENCY, LEAKAGE | The purpose of the present study was to determine the effects of different amounts of choline intakes on muscle responses to RET. We found that low choline intake (~51% of AI) resulted in diminished strength gains with 12 weeks of RET in 50-to-69-year-old individuals, compared to choline intakes of ~68% or ~118% of AI.... | PMC10534351 |
Author Contributions | T.V.L. | Conceptualization, S.E.R. and C.W.L.; methodology, S.E.R.; validation, T.V.L., E.G., C.W.L. and S.E.R.; formal analysis, C.W.L.; investigation, C.W.L., T.V.L., E.G., V.C.W.C. and S.B.; resources, S.E.R.; data curation, C.W.L. and E.G.; writing—original draft preparation, C.W.L.; writing—review and editing, C.W.L., T.V.... | PMC10534351 | |
Institutional Review Board Statement | The study was conducted in accordance with the Declaration of Helsinki and approved by the Institutional Review Board of Texas A&M University. | PMC10534351 | ||
Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. | PMC10534351 | ||
Data Availability Statement | The data presented in this study are available from the authors upon reasonable request. | PMC10534351 | ||
Conflicts of Interest | The authors declare no conflict of interest. The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript; or in the decision to publish the results. | PMC10534351 | ||
Background | diet-related disease, SSBs | SECONDARY | Pictorial health warnings on sugar-sweetened beverages (SSBs) are a promising policy for preventing diet-related disease in children. A recent study found that pictorial warnings reduced parents’ purchases of SSBs for their children by 17%. However, the psychological mechanisms through which warnings affect parental be... | PMC10290296 |
Methods | In 2020–2021, parents of children ages 2 to 12 years ( | PMC10290296 | ||
Results | SSBs | Two of the 11 constructs were statistically significant mediators. First, the impact of pictorial warnings on the likelihood of purchasing any SSB was mediated by parents’ perceptions that SSBs were healthier for their child (mediated effect= −0.17; 95% CI = − 0.33, − 0.05). Second, parents’ intentions to serve SSBs to... | PMC10290296 | |
Conclusions | SSBs | Pictorial warnings reduced parents’ purchases of SSBs for their children by making parents think SSBs are less healthful for their children and reducing their intentions to serve SSBs to their children. Communication approaches that target healthfulness perceptions and intentions to serve SSBs may motivate parents to b... | PMC10290296 | |
Supplementary Information | The online version contains supplementary material available at 10.1186/s12966-023-01469-3. | PMC10290296 | ||
Keywords | PMC10290296 | |||
Introduction | obesity, Health behavior, SSBs | OBESITY, DENTAL CARIES | Consumption of sugar-sweetened beverages (SSBs) is associated with numerous health problems in children, including obesity and dental caries [Mounting research indicates that SSB warnings are a promising tool for reducing parents’ selection of SSBs for their children. Three experiments have found that warnings on SSBs ... | PMC10290296 |
Methods | PMC10290296 | |||
Participants | SECONDARY | The current study used secondary data from a randomized trial with 326 parents of children ages 2–12 years old [To be eligible, participants had to be at least 18 years of age and the parent or guardian (hereafter “parent”) of at least one child ages 2–12 years old who consumed at least one SSB in the past week. Additi... | PMC10290296 | |
Setting | The study took place at the UNC Mini Mart, a 245-square-foot convenience store designed for research purposes, in Chapel Hill, NC [ | PMC10290296 | ||
Procedures | The trial used a parallel arm study design, with staff randomly assigning participants to one of the two trial arms: pictorial warnings or control labels. Staff prepared the Mini Mart before a participant’s arrival based on the assigned trial arm. In the pictorial warnings arm, staff applied one of two warning labels (... | PMC10290296 | ||
Measures | In the current study, we examined mediators of the impact of the pictorial warnings on purchasing any SSBs in the Mini Mart (yes/no), which was the primary outcome for both this study and the main trial [The survey assessed a range of potential psychological mediators using measures adapted or used verbatim from previo... | PMC10290296 | ||
Analysis | The analytic sample included 325 participants with complete data on the primary outcome in the main trial, excluding one person with missing data on the primary outcome of purchasing any SSB. Mediation analyses used the MacKinnon approach [
Primary mediation modelAnalyses used the PROCESS macro for SPSS (version 4.1) [... | PMC10290296 | ||
Association of mediators on purchasing SSBs | When examining the associations between mediators and purchasing any SSBs, controlling for trial arm ( | PMC10290296 | ||
Discussion | SSBs | DISEASE | In this study, we found that pictorial health warnings reduced parents’ purchases of SSBs for their children by reducing the perceived healthfulness of SSBs. Additionally, pictorial warnings changed parents’ purchase behavior by lowering their intentions to serve SSBs to their children, in line with health behavior the... | PMC10290296 |
Conclusions | This randomized trial found that pictorial SSB warnings reduced parents’ purchases of SSBs for their children by making parents think SSBs are less healthful for their children and changing parents’ intentions about serving SSBs. These results stand in contrast to prior studies showing that message reactions explain th... | PMC10290296 | ||
Acknowledgements | The authors thank Carmen E. Prestemon and Mirian I. Avendaño-Galdamez for their role in data collection and study coordination. The authors thank the organization El Centro Hispano for their consultation and collaboration on this project. | PMC10290296 | ||
Authors’ contributions | MGH, AHG, AJL, and LST conceptualized the study. MGH, LST, AHG, and AJL acquired funding. ICAH managed the study. TQ analyzed the data. All authors contributed to drafting the manuscript and provided critical feedback on multiple drafts of the paper. | PMC10290296 | ||
Funding | BLOOD, HEART, LUNG, RECRUITMENT | Data collection for the randomized trial was supported by grant #76290 from the Robert Wood Johnson Foundation through its Healthy Eating Research program. General support was provided by NIH grant to the Carolina Population Center, grant numbers P2C HD050924 and T32 HD007168. K01HL147713 from the National Heart, Lung,... | PMC10290296 | |
Data Availability | The dataset and syntax used in the current study are available from the corresponding author on reasonable request. | PMC10290296 | ||
Declarations | PMC10290296 | |||
Ethics approval and consent to participate | The University of North Carolina’s Institutional Review Board approved this study procedures (study # 19–0277). | PMC10290296 | ||
Consent for publication | Not applicable. | PMC10290296 | ||
Competing interests | None to disclose. | PMC10290296 | ||
Abbreviations | Sugar-sweetened beverage | PMC10290296 | ||
References | PMC10290296 | |||
Abstract | T.-P.S. and C.-T.L. contributed equally. | PMC10229851 | ||
Background | TRD, depressive, treatment-resistant depression, ideation | The benefits of low-dose ketamine for patients with treatment-resistant depression (TRD) and prominent suicidal ideation require further investigation. The effects of treatment refractoriness, the duration of the current depressive episode, and the number of prior antidepressant failures on ketamine efficacy also requi... | PMC10229851 | |
Methods | TRD, Depression, depressive, ideation | We recruited 84 outpatients with TRD and prominent suicidal ideation—defined as a score ≥4 on item 10 of the Montgomery–Åsberg Depression Rating Scale (MADRS)—and randomized them into 2 groups to receive 0.5 mg/kg ketamine or 0.045 mg/kg midazolam. We assessed depressive and suicidal symptoms prior to infusion; 240 min... | PMC10229851 | |
Results | According to the MADRS scores, the antidepressant effect ( | PMC10229851 | ||
Conclusions | TRD, depressive, ideation | Low-dose ketamine infusion is a safe, tolerable, and effective treatment for patients with TRD and prominent suicidal ideation. Our study highlights the importance of timing; specifically, ketamine is more likely to achieve therapeutic response when the current depressive episode lasted <24 months and the number of fai... | PMC10229851 | |
Significance Statement | TRD, depressive, ideation | Low-dose ketamine infusion had rapid antidepressant and antisuicidal effects among patients with TRD and prominent suicidal ideation. In addition, the antidepressant effect of ketamine persisted for up to 2 weeks, but the antisuicidal effect lasted only 5 days. Furthermore, timing of ketamine treatment is crucial; spec... | PMC10229851 | |
INTRODUCTION | TRD, deaths, depressive, ideation | Over the last half century, worldwide suicide rates have increased by 60%, and suicide accounted for more than 1 million deaths in 2020 (A growing body of evidence has supported the rapid and sustained antisuicidal effect of low-dose ketamine (In a real-world clinical setting, however, TRD and severe suicidal ideation ... | PMC10229851 | |
METHODS | PMC10229851 | |||
Inclusion Criteria and Study Procedure | depressive disorder, ideation | DISORDERS | Adult outpatients aged between 20 and 64 years who were diagnosed with major depressive disorder based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, with inadequate response to at least 2 different antidepressants with adequate dosage and treatment duration and had a prominent suicidal id... | PMC10229851 |
Statistical Methods | NSI, Suicide Ideation | Continuous variables and nominal variables were analyzed using 1-way ANOVA and Fisher’s chi square tests, respectively, to assess differences between the 2 infusion groups (0.5 mg/kg ketamine or 0.045 mg/kg midazolam) with respect to demographic and clinical data. The generalized estimating equation (GEE) models with t... | PMC10229851 | |
RESULTS | TRD, ideation, posttraumatic stress disorder, treatment-resistant depression, Ideation, PTSD, Suicide Ideation, Depression, Maudsley | REMISSION, POSITIVE | The study flowchart is shown in
Demographic Characteristics, Baseline Clinical Symptoms, and Treatment Outcomes of Patients With TRD and Prominent Suicidal Ideation Receiving a Single Infusion of Ketamine vs Midazolam PlaceboAbbreviations: BMI, body mass index; CSSRS-ISS, Columbia-Suicide Severity Rating Scale-Ideatio... | PMC10229851 |
DISCUSSION | TRD, ideation, tumor necrosis, depressive disorder, depressive, depression | DISEASE, TUMOR NECROSIS | Our results suggest that the antidepressant effect of low-dose ketamine infusion persists for 14 days in patients with TRD and prominent suicidal ideation. However, based on clinician-rated and self-reported measures, the antisuicidal effect of the ketamine infusion may diminish after 5–7 days. Additionally, our study ... | PMC10229851 |
CONCLUSIONS | TRD, depressive, ideation | In summary, our study results support the rapid antidepressant and antisuicidal effects of low-dose ketamine infusion on patients with TRD and prominent suicidal ideation. The antidepressant effect of ketamine persisted for up to 2 weeks, but the antisuicidal effect lasted only 5 days. In addition, timing of ketamine t... | PMC10229851 | |
Supplementary Material | Click here for additional data file.Click here for additional data file.Click here for additional data file. | PMC10229851 | ||
Acknowledgments | We thank all research assistants, physicians, and pharmacist and nursing staff at D020 Unit of Department of Psychiatry, Taipei Veterans General Hospital and at the Department of Psychiatry, Cheng Hsin General Hospital for their assistance during the study process, without whom this work could not have been possible. W... | PMC10229851 | ||
Author Contributions | W.-C.M. | Drs M.-H.C. and T.-P.S. designed the study. Drs M.-H.C., T.-P.S., W.-C.L., and C.-T.L., and Miss H.-J.W. performed the clinical trials. Dr M.-H.C. analyzed the data and drafted the manuscript. Drs T.-P.S., C.-T.L., W.-C.L., Y.-M.B., S.-J.T., W.-C.M., and P.-C.T. enrolled the candidate patients and performed the literat... | PMC10229851 | |
Interest Statement | None of the authors in this study had any conflict of interest to declare. | PMC10229851 | ||
References | PMC10229851 | |||
Background | Evidence-based practice (EBP) is the gold standard approach in physiotherapy, and it is essential that students are aware that it is the appropriate way to provide the patient with the best possible treatment. Undergraduate research (UR) can positively influence learning outcomes and research competencies related to EB... | PMC10559614 | ||
Methods | Students in the first academic year of the Bachelor´s Degree in Physiotherapy of University of Deusto (Donostia-San Sebastian, Spain) who were enrolled in the subject ‘Introduction to Research Methodology’ were invited to take part in a real RCT which consisted of three groups: intervention, placebo, and control group.... | PMC10559614 | ||
Results | From the 114 students enrolled in the subject, 102 participated in the RCT and 110 answered the final questionnaire. Regarding the development of research competencies, UR had a positive or very positive impact on critical thinking (67% and 18%, respectively) and in the assessment of methodological quality (66% and 23%... | PMC10559614 | ||
Conclusion | The novel UR program provided students with a new opportunity to improve their knowledge of RCT procedures, thus making the learning process more meaningful. Therefore, ways of teaching and learning focused on improving research and inquiry attitudes should be considered and integrated into the health care curriculum, ... | PMC10559614 | ||
Trial registration | Australian New Zealand Clinical Registry: ACTRN12622000263796p (14/02/2022). | PMC10559614 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12909-023-04716-0. | PMC10559614 | ||
Keywords | PMC10559614 | |||
Background | The development of research skills at higher education is considered a challenge where the institutions and lecturers try to combine educational and research attitudes, while inexperienced and novice students need to develop scientific skills [EBP consists in the application of the best scientific evidence in clinical ... | PMC10559614 | ||
Methods | BLIND | A real RCT where students could take part as researchers and/or participants as the main UR strategy was undertaken. The aim of the RCT was to evaluate the effectiveness of a superficial neuromodulation device developed by an external private company (© 2020 Irmoki). However, the true aim of the study reported here, to... | PMC10559614 | |
Procedures related to RCT | PMC10559614 | |||
Study design and registration | This RCT was designed following the Consolidated Standard of Reporting Trials for Controlled Studies (CONSORT) statement, registered with the Australian New Zealand Clinical Registry (ACTRN12622000263796p, 14/02/2022) and approved by the Research Ethics Committee of the University of Deusto (ETK-21/21–22). Details abou... | PMC10559614 |
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