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Declarations | PMC9957611 | |||
Ethics approval and consent to participate | Ethical approval was provided by the Ghana Health Service Ethics Review Committee (protocol ID no: GHS-ERC 009/11/20), and the Institutional Review Board of KBTH (protocol ID no: KBTH-IRB 000175/2021). Prior to any study procedures, all participants gave written informed consent in person. The study was conducted in line with the principles of the Declaration of Helsinki. | PMC9957611 | ||
Consent for publication | Consent for publication is not applicable. | PMC9957611 | ||
Competing interests | "The authors declare that they have no competing interests". | PMC9957611 | ||
References | PMC9957611 | |||
Subject terms | SARS-CoV-2 infection | MAY, SARS-COV-2 INFECTION | ABO blood type has been reported as a potential factor influencing SARS-CoV-2 infection, but so far mostly in studies that involved small samples, selected population and/or used PCR test results. In contrast our study aimed to assess the association between ABO blood types and SARS-CoV-2 infection using seroprevalence data (independent of whether or not individuals had symptoms or sought for testing) in a large population-based sample. Our study included 67,340 French participants to the SAPRIS-SERO multi-cohort project. Anti-SARS-CoV-2 antibodies were detected using ELISA (targeting the proteins spike (S) and nucleocapsid (NP)) and seroneutralisation (SN) tests on dried blood spots collected in May–November 2020. Non-O individuals (and especially types A and AB) were more likely to bear anti SARS-CoV-2 antibodies (ELISA-S, 2964 positive cases: OR | PMC10034870 |
Introduction | infection, SARS-CoV-2 infection | COVID-19 (CORONAVIRUS DISEASE 2019), SARS-COV-2 INFECTION, DISEASE, INFECTION, CORONAVIRUS, SEVERE ACUTE RESPIRATORY SYNDROME | Since 2020, the world has been struggling with the COVID-19 (Coronavirus Disease 2019) pandemic caused by the SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2). The research community has mobilized to identify potential risk factors associated with SARS-CoV-2 infection and COVID-19 severity, in an effort to better understand the dynamic of infection, pinpoint individuals at higher risk and help prevent the disease and related adverse outcomes. Early reports comparing the distribution of ABO blood types between individuals infected or not by the SARS-CoV-2, suggested that ABO blood types could be related to the risk of SARS-CoV-2 infection | PMC10034870 |
Methods | MAY | The SAPRIS (“SAnté, Perception, pratiques, Relations et Inégalités Sociales en population générale pendant la crise COVID-19”) study was set up in April 2020 to investigate various aspects of the COVID-19 crisis (COVID-19 infection/diagnosis and experience of lockdown), based on a consortium of existing French prospective cohort studies. In May 2020, participants from the Constances, E3N-E4N and NutriNet-Santé cohort studies answering SAPRIS questionnaires were also invited to take part in the SAPRIS-SERO project which aimed to estimate the seroprevalence of antibodies against SARS-CoV-2 at the population level, as previously described | PMC10034870 | |
Ethics approval and informed consent | The SAPRIS-SERO study (registered #NCT04392388) was conducted in accordance with the relevant guidelines and regulations and was approved by the ethics committee CPP Sud-Méditerranée III on April 27th 2020 and by the CNIL #920,193. All participants provided written or electronic informed consent for participation in each cohort and a specific electronic informed consent for participation in the SAPRIS-SERO study. | PMC10034870 | ||
Acknowledgements | The authors warmly thank all the volunteers of the Constances, E3N-E4N and NutriNet-Santé cohorts for their continuous participation in the study and for participating in the SAPRIS-SERO project. We thank the CEPH-Biobank staff for their adaptability and the quality of their work. In the virology department, we thank Dr Nadège Brisbarre and the technical staff for impeccable management of samples and serological assays. | PMC10034870 | ||
Author contributions | The authors’ contributions were as follows – M.D.T., M.T. conceptualized the study and defined the analytical strategy; F.S.E.: performed statistical analyses; M.D.T. supervised statistical analyses and drafted the manuscript; M.T.: supervised statistical analyses and writing; F.S.E., N.D.P., Y.E., J.A., P.G., S.H., G.S., M.Z., E.W., X.dL, F.C., M.T., SAPRIS-SERO study group: played a key role in the acquisition of the data. All authors critically helped in the interpretation of results, revised the manuscript and provided relevant intellectual input. They all read and approved the final manuscript. M.D.T. and M.T. had primary responsibility for the final content. | PMC10034870 | ||
Funding | NutriNet-Santé, Cancer | CANCER | The SAPRIS/SAPRIS-SERO projects received funding from ANR (Agence Nationale de la Recherche, #ANR-20-COVI-000, #ANR-10-COHO-06), Fondation pour la Recherche Médicale (#20RR052-00), and Inserm (Institut National de la Santé et de la Recherche Médicale, #C20-26). The NutriNet-Santé cohort study was supported by the following public institutions: Ministère de la Santé, Santé Publique France, Institut National de la Santé et de la Recherche Médicale (INSERM), Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement (INRAE), Conservatoire National des Arts et Métiers (CNAM) and Université Sorbonne Paris Nord. The CONSTANCES cohort benefits from grant ANR-11-INBS-0002 from the French National Research Agency. CONSTANCES is supported by the Caisse Nationale d’Assurance Maladie, the French Ministry of Health, the Ministry of Research, and the Institut National de la Santé et de la Recherche Médicale (INSERM). CONSTANCES is also partly funded by AstraZeneca, Lundbeck, L’Oréal, and Merck Sharp & Dohme Corp. The E3N-E4N cohort is supported by the following institutions: Ministère de l'Enseignement Supérieur, de la Recherche et de l'Innovation, INSERM, University Paris-Saclay, Gustave Roussy, the MGEN, and the French League Against Cancer. Study investigators are independent from the funders. Funders had no role in the study design, the collection, analysis, and interpretation of data, the writing of the manuscript, or the decision to submit the article for publication. | PMC10034870 |
Data availability | Data from the study are protected under the protection of health data regulation set by the French National Commission on Informatics and Liberty (Commission Nationale de l’Informatique et des Libertés, CNIL). The data can be made available upon reasonable request to the corresponding author (m.deschasaux@eren.smbh.univ-paris13.fr), after a consultation with the steering committee of the SAPRIS-SERO study. The French law forbids us to provide free access to SAPRIS-SERO data; access could however be given by the steering committee after legal verification of the use of the data. Please, feel free to come back to us should you have any additional question. | PMC10034870 | ||
Competing interests | The authors declare no competing interests. | PMC10034870 | ||
References | PMC10034870 | |||
Background | CHB, chronic hepatitis B | CHB, HEPATITIS B VIRUS (HBV) | Hepatitis B virus (HBV) core protein-targeting antivirals (CpTAs) are promising therapeutic agents for treating chronic hepatitis B (CHB). In this study, the antiviral activity, pharmacokinetics (PK), and tolerability of ZM-H1505R (Canocapavir), a chemically unique HBV CpTA, were evaluated in patients with CHB. | PMC10022191 |
Methods | CHB | CHB | This study was a double-blind, randomized, placebo-controlled phase 1b trial in Chinese CHB patients. Noncirrhotic and treatment-naive CHB patients were divided into three cohorts (10 patients per cohort) and randomized within each cohort in a ratio of 4:1 to receive a single dose of 50, 100, or 200 mg of Canocapavir or placebo once a day for 28 consecutive days. | PMC10022191 |
Results | ADVERSE REACTIONS, ADVERSE EVENTS | Canocapavir was well tolerated, with the majority of adverse reactions being grade I or II in severity. There were no serious adverse events, and no patients withdrew from the study. Corresponding to 50, 100, and 200 mg doses of Canocapavir, the mean plasma trough concentrations of the drug were 2.7-, 7.0-, and 14.6-fold of its protein-binding adjusted HBV DNA EC | PMC10022191 | |
Conclusions | CHB, HBV infection | CHB | Canocapavir treatment is tolerated with efficacious antiviral activity in CHB patients, supporting its further development in treating HBV infection. | PMC10022191 |
Trial registration | ClinicalTrials.gov, number NCT05470829). | PMC10022191 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12916-023-02814-w. | PMC10022191 | ||
Keywords | PMC10022191 | |||
Background | infection, deaths, viral infections | HEPATITIS B, VIRUS, VIRAL INFECTION, INFECTION, CHRONIC HEPATITIS, CHB | Chronic hepatitis caused by hepatitis B virus (HBV) infection is a major global health problem, with an estimated 0.6–1 million deaths per year [Developing drugs targeting different HBV life cycle steps has become a critical approach for treating viral infections, such as CHB [HBV core protein-targeting antivirals (CpTAs) are HBc-targeting small molecule compounds [Distinguished from the abovementioned CAM-A and CAM-E CpTAs, Canocapavir is a novel CAM-E CpTA with a pyrazole structure and a new binding site in the HBc [ | PMC10022191 |
Methods | PMC10022191 | |||
Study design | MAY | This was a randomized, open-label, placebo-controlled, phase 1b study (Clinical Trial Registration Number: NCT05470829; Chinese Clinical Trial Registration Number: CTR20210686), which was conducted at the Phase I Clinical Research Center, The First Hospital of Jilin University (Jilin, China), during the period from May to November of 2021. In order to minimize the safety risk of Canocapavir, an adaptive ascending dosing strategy was adopted for Canocapavir treatment in this study. The second and third assigned doses were initiated only after the safety data from the previous dose was reviewed and determined to be safe by the Principal Investigator and the Sponsor on day 8 postdosing (post drug administration days). Canocapavir was administered at the Clinical Research Center on days 1–8 and day 28 and at home on days 9–27 under the same conditions (fixed administration time and fasting condition). Patients were required to visit the facility for follow-up on days 15, 22, 27, 43 ± 1, and 57 ± 2 postdosing. The study protocol and informed consent forms were prepared according to the principles of the Declaration of Helsinki. The study protocol was approved by the Institutional Review Board of the First Hospital of Jilin University (approval number: 20Y201-006). All recruited patients provided written informed consent before participating in any study-related procedures. | PMC10022191 | |
Participants | The main inclusion criteria of the participants were as follows: 1) adult subjects aged 18–65 years old who were treatment-naive or had terminated their treatment at least six months for nucleoside analog use or at least one year for interferon use prior to screening; 2) showing serum HBV DNA ≥ 2 × 10 | PMC10022191 | ||
Procedures | PMC10022191 | |||
Randomization and blinding | CHB | CHB | A total of 30 CHB patients were recruited in this study and were randomly assigned into three cohorts (Design of this study | PMC10022191 |
Assessment of adverse reactions and drug tolerability | toxicity | ADVERSE EVENTS, ADVERSE EVENT, ADVERSE REACTIONS, ADVERSE EVENT | To examine possible adverse events (AEs) and adverse reactions (an adverse event is definitely, probably, or possibly related to the drug) in this study, the recruited patients underwent regular clinical laboratory testing, 12-lead electrocardiograms, examination of vital signs, abdominal ultrasound, and regular physical examinations, using the baseline data as a control. The severity of AEs and laboratory abnormalities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, which defines toxicity criteria. The AEs were coded using the Medical Dictionary for Regulatory Activities, version 24.1 (McLean, VA, USA). | PMC10022191 |
Pharmacokinetics | BLOOD | Blood samples for Canocapavir PK analysis were collected at different time points, and were collected and placed into a vacutainer with an anticoagulant (K | PMC10022191 | |
Antiviral activity | BLOOD | The changes in the serum levels of HBV DNA, HBV pgRNA, HBcrAg, HBsAg, HBsAb, HBeAg, HBeAb, and HBcAb at different time points were examined. Blood samples were collected on the initial screening day (baseline) and days 1, 8, 15, 22, 29, 43 ± 1, and 57 ± 2 postdosing. Blood samples for detecting viral resistance to Canocapavir were collected on day 1 (predosing), day 29 (24 h after day 28 dosing), and day 57 ± 2 postdosing. | PMC10022191 | |
Statistical analysis | The following observed data were used for the analysis of the plasma PK parameters with the noncompartmental PK approach using WinNonlin, version 8.2, software (Pharsight Co., Mountain View, CA, USA): the maximum observed plasma concentration (Cmax), the time to maximum observed serum concentration (Tmax), area under the concentration–time curve from the time of dosing to the last time point with the measurable plasma concentration (AUC0-t) prior to the next dose, AUC from the time of dosing extrapolated to infinity (AUC | PMC10022191 | ||
Results | PMC10022191 | |||
Safety and tolerability | ADVERSE REACTIONS | This study showed that Canocapavir was safe and tolerated over the 28 days of treatment. No serious AE occurred during the period of the trial. No patients withdrew from the study due to an AE, thus allowing the tolerability, antiviral, and PK analyses on data from all patients. A total of 76.7% (23/30) of the patients experienced 49 cases of AEs, in which 38 cases occurred in 75% of patients from the Canocapavir cohort, while 11 cases were from 83% of patients from the placebo cohort.In total, 50% (15/30) of the subjects experienced 31 cases of adverse reactions, in which 24 cases occurred in 50% of patients from the Canocapavir cohort, while 7 cases were from 50% of patients from the placebo cohort. Most adverse reactions were mild or moderate in severity and resolved without treatment. The incidence rates of adverse reactions in each cohort were as follows: 50 mg, 37.5% (3/8); 100 mg, 62.5% (5/8); 200 mg, 50.0% (4/8); and placebo, 50.0% (3/6). The incidence of adverse reactions among patients who received Canocapavir was not significantly correlated to its increased dose (Table Frequency of adverse reactions in each treatment cohort [case, number of subjects (%)] | PMC10022191 | |
Antiviral activity | DRUG WITHDRAWAL | The level of HBV DNA decreased profoundly from baseline in the patients receiving three doses of Canocapavir but not in those receiving placebo. The HBV DNA level decreased greatly starting from day 8, with the average maximum decrease on day 22 or day 29. The HBV DNA level gradually returned to the baseline after drug withdrawal and recovered to the baseline at follow-up on day 57. Moreover, the HBV DNA level decreased overwhelmingly in patients who received 100 mg or 200 mg of Canocapavir compared to those who received 50 mg. The mean maximum HBV DNA decreases were -1.54, -2.50, -2.75, and -0.47 logChanges of HBV virologic markers from baseline during treatment with Canocapavir or placebo. This study also showed that the HBV pgRNA level decreased profoundly from baseline in the patients who received different doses of Canocapavir but not in those who received the placebo. As mentioned above, the declining trend was similar to that of HBV DNA. The degree of HBV pgRNA decrease in the patients who received 100 mg or 200 mg of Canocapavir was similar, but it was deeper than that in the patients who received 50 mg. The mean maximum HBV pgRNA decreases were -1.53, -2.35, -2.34, and -0.17 logIn addition, within the duration of treatment, the HBcrAg level in each dosage cohort decreased to a certain extent from baseline. The HBcrAg level decreased more in the patients who received 100 mg or 200 mg of Canocapavir than in those who received 50 mg of Canocapavir or the placebo. The maximum mean HBcrAg decreases were -0.30, -0.61, -0.51, and -0.38 log | PMC10022191 | |
Discussion | CHB, HBV infection, liver decompensation, hepatomegaly, liver stiffness, hepatitis, steatosis, chronic disease | ADVERSE REACTIONS, VIRUS, LIVER DECOMPENSATION, LIVER CIRRHOSIS, ADVERSE REACTION, HEPATOCELLULAR CARCINOMA, LACTIC ACIDOSIS, HEPATITIS, STEATOSIS, CHB, CHRONIC DISEASE | In this phase 1b study, we examined the safety, tolerability, PK profiles, and preliminary clinical efficacy of Canocapavir, a novel CAM-E CpTA for the treatment of patients with CHB. Our results showed that Canocapavir was safe and well tolerated in patients with CHB, and serum HBV DNA and HBV pgRNA were profoundly reduced after a 28-day treatment of Canocapavir.Since CHB is a chronic disease and requires long-term treatment, safety is an important feature that a new drug must possess. In this study, an overall 50% incidence rate for adverse reactions was observed, which were not significantly correlated with the drug dosage. Most adverse reactions in this study were mild in severity, including elevation of ALT or AST. The data show that 12.5–37.5% of the patients who received Canocapavir had a grade I adverse reaction, while 50% of patients who received placebo had a grade I–II adverse reaction. These findings were similar with other CAM-E CpTAs, such as NVR 3–778 and ABI-H0731 [In our previous study [In contrast to this observation, we also noticed that in patient E4005, who received the placebo, the ALT level was 21.4U /L at baseline and increased gradually after day 31 (i.e., 3 days after the last dosing of the placebo), reaching to a maximum of 158.2 U/L on day 64. Similarly, in another patient (E4007) who also received the placebo, the ALT level was 65.8 U/L at baseline and increased gradually after day 15, reaching a maximum of 300.9 U/L on day 57 (Additional file Chan et al. have reported that in cases of liver cirrhosis, the optimal cutoff values for the liver stiffness measurement were 8.4 kPa (98% sensitivity), 9.0 kPa (maximum sum of sensitivity and specificity), 13.4 kPa (94% specificity), and 13.4 kPa (maximum diagnostic accuracy, 85%) [The occurrence frequency and rate of AEs, such as an increased ALT level, were similar among the different treatment groups. For example, the occurrence frequencies of an increased ALT level in the 50 mg, 100 mg, and 200 mg groups of Canocapavir and placebo were 2, 3, 3, and 3 cases, respectively (Table It has been reported that in the treatment with nucleos(t)ide analogues, a decrease of serum phosphorus levels and an increase of serum creatinine levels were observed; these can also happen in the presence of lactic acidosis and severe hepatomegaly with steatosis, including fatal cases. Severe acute exacerbations of hepatitis have been found in HBV-infected patients who have discontinued anti-hepatitis B therapy with nucleos(t)ide analogues [The PK profiles of Canocapavir showed rapid absorption (TThe conversion of HBV RNA to DNA occurs within viral core particles in the cytoplasm through reverse transcription, which is the prerequisite for both generations of progeny virus particles and replenishment of the HBV cccDNA pool in the nucleus. It has been postulated that complete and sustained disruption of the processes mentioned above may help accelerate the exhaustion of the cccDNA pool, eventually leading to permanent sterilization of HBV infection [The changes in HBsAg, HBeAg, and HBcrAg levels have been studied for several CpTAs in phase I–II trials and generally are limited [One subject (E2003) was found to have a pre-existing substitution (P25S) in the HBc known to reduce the susceptibility of the virus to CpTAs [This study provides the first clinical evidence that substantial inhibition of viral production in patients with CHB can be achieved by Canocapavir treatment. In a previous report, long-term entecavir therapy was associated with a decreased incidence of liver decompensation and hepatocellular carcinoma [ | PMC10022191 |
Study limitation | This study does have some limitations that must be addressed in future studies. These include a small number of patients, a short treatment and follow-up period, and the lack of analysis of immune-inflammatory factors. These limitations will be addressed in future multicenter studies of Canocapavir in more patients with a more extended treatment and follow-up period. | PMC10022191 | ||
Conclusions | CHB | ADVERSE REACTIONS, VIRUS, CHB | Canocapavir was well tolerated. Most of the adverse reactions were grade I or II in severity. No dose-dependency was observed for either the frequency or intensity of AEs. Corresponding to 50–200-mg doses of Canocapavir, a linear PK profile and a low-to-mild accumulation rate (1.26–1.99) were notable. After oral dosing, significant margins were observed between plasma exposure of Canocapavir and its anti-HBV activity in vitro, supporting a once-a-day dosing in future trials. Canocapavir treatment for 28 days induced a substantial reduction of serum levels of both HBV DNA and HBV pgRNA in HBV patients. One subject (E2003) in the 50 mg of Canocapavir group did not respond to the treatment; this patient had a pre-existing mutation in the HBc (substitution of P25S), which is known to reduce the susceptibility of the virus to other CpTAs. The virus of the test subjects will need to be sequenced prior to treatment initiation, and monitored during and after treatment in future clinical studies. Taken together, these results support further clinical investigation of Canocapavir as a potent therapeutic agent for treating patients with CHB. | PMC10022191 |
Acknowledgements | This work was financially supported by the Capital Construction Funds within the provincial budget for 2020 (in the category of Innovation Capacity Construction, project number: 2020C038-1) and was also sponsored by Shanghai Zhimeng Biopharma, Inc. | PMC10022191 | ||
Authors’ contributions | HL | XJ, HC1, ZZ, HZ, JN, and YD designed the study. HJ, JM, MW, HC2, XL, CL, JL CL, YH, XZ, HZ, and YD performed the clinical trial. JM, HZ, JN, and YD analyzed the data. HJ, HZ, and YD wrote and edited the manuscript as well as composed the figures. BH, TX, GL, AD, BL, RG, HL, and ZW synthesized the drug and assisted in this study. ZZ edited the manuscript. All authors approved the final version of the manuscript. | PMC10022191 | |
Funding | This work was financially supported by the Capital Construction Funds within the provincial budget for 2020 (in the category of Innovation Capacity Construction, project number: 2020C038-1) and was also sponsored by Shanghai Zhimeng Biopharma, Inc. | PMC10022191 | ||
Availability of data and materials | The data that support the findings of this study are available on request from the corresponding authors after the completion of the study. The data are not publicly available due to privacy or ethical restrictions. | PMC10022191 | ||
Declarations | PMC10022191 | |||
Ethics approval and consent to participate | The study protocol was approved by the Institutional Review Board of the First Hospital of Jilin University, and conducted according to the Declaration of Helsinki, Guidelines for Good Clinical Practice, and local laws and regulations. The ethics approval number is 20Y201-006. All patients provided written informed consent. | PMC10022191 | ||
Consent for publication | Not applicable. | PMC10022191 | ||
Competing interests | XJ, BH, TX, GL, AD, BL, RG, HL, ZW, HC, and ZZ are employees of Shanghai Zhimeng Biopharma, which sponsored this study. The other authors declare no conflicts of interest. | PMC10022191 | ||
References | PMC10022191 | |||
Objective | T2DM, P. | TYPE 2 DIABETES MELLITUS | Edited by: João P. Magalhães, University of Lisbon, PortugalReviewed by: Megan Hetherington-Rauth, Universidade de Lisboa, Portugal; Romeu Mendes, University Porto, PortugalThis article was submitted to Cardiovascular Endocrinology, a section of the journal Frontiers in EndocrinologyTo compare the effects of different aerobic training protocols on cardiometabolic variables in patients with type 2 diabetes mellitus (T2DM). | PMC9900112 |
Methods | T2DM | This study was a parallel clinical trial. Fifty-two men and women with T2DM (>40 years) were randomly allocated into three groups, and 44 (22 males/22 females) were included in the final analysis. Exercise intensity was based on the speed corresponding to the maximum oxygen consumption (v | PMC9900112 | |
Results | There was a significant difference between groups for changes on | PMC9900112 | ||
Conclusion | Low-volume HIIT promoted greater improvements in cardiorespiratory capacity in comparison with low-volume MICT, independent of the protocols used. There were no other differences between groups. All protocols improved at least one of the variables analyzed; however, the most evident benefits were after the high-intensity protocols, especially L-HIIT. | PMC9900112 | ||
Introduction | T2DM, disability | TYPE 2 DIABETES MELLITUS | Type 2 diabetes mellitus (T2DM) is one of the leading causes of disability worldwide (HIIT is a type of aerobic training that consists of performing high intensity exercise bouts alternated with passive or active recovery periods (Kilpatrick et al., (In this context, it is important to determine whether the use of different HIIT protocols could affect cardiometabolic adaptations in T2DM in order to allow an adequate cost benefit analysis. Therefore, the aim of the present study was to investigate the effects of three different types of aerobic training protocols on cardiometabolic parameters in people with T2DM. | PMC9900112 |
Material and methods | PMC9900112 | |||
Study design | T2DM | This study is a parallel randomized clinical trial that involved individuals with T2DM of both sex that performed different aerobic training protocols, two times per week for eight weeks. The study was performed at the Hospital of the Federal University of Goias (Goiania, Brazil), approved by the relevant Human Research Ethics Committee (Protocol No. 2,667,732, CAAE No. 54522016.6.0000.5083) and registered on the Brazilian clinical trial records (ID: RBR-4RJGC3). All participants gave written informed consent in accordance with the Declaration of Helsinki. Participants were assigned by randomization to one of three groups using a specialized website (Before and after the training period, participants were evaluated for anthropometric measures, resting BP, cardiopulmonary exercise test and blood markers. Anthropometric measures included weight and height for calculating body mass index (BMI), as well as waist and hip circumference. Weight was measured using a digital scale (BC 553, TanitaAll experimental procedures were carried out in the morning, with relative humidity between 40 and 60%, and temperature between 22 and 24°C, according to American College of Sports Medicine guidelines (ACSM) ( | PMC9900112 | |
Participants | renal or liver failure, cardiovascular diseases, neoplasm, arrhythmias, hypothyroidism, T2DM, obstructive pulmonary disease | CARDIOVASCULAR DISEASES, HEART, UNSTABLE ANGINA, OBSTRUCTIVE PULMONARY DISEASE, EXTRASYSTOLES, NEOPLASM, DIABETES, ARRHYTHMIAS, HYPOTHYROIDISM, EYE | Sixty participants with T2DM were recruited from 3rd Diabetes Task Force promoted by the Eye Bank Foundation of Goiás. To be included in the study, participants had to be 40 years old or more, diagnosed with T2DM, have a fasting glycemia above 126 mg/dL and/or glycated hemoglobin greater than 6.4%, and to not participate in other physical training program. Patients were excluded if they were active smokers or had myocardial revascularization, arrhythmias and frequent extrasystoles at rest or during physical exertion, unstable angina, obstructive pulmonary disease, neoplasm, renal or liver failure, orthopedic limitations, and uncontrolled hypothyroidism and cardiovascular diseases at moderate and high risk (classes C and D), according to the criteria American Heart Association (After cardiopulmonary exercise tests, eight patients were excluded, including three with an exercise capacity<6 METS, two with uncontrolled arrhythmias during physical exertion, one with unstable angina, and two with a reduction in SBP during exercise to lower levels than resting SBP. Two patients were excluded from the final analyses because they presented irregular data for determined variables. The enrolment process until participant’s inclusion in final analyses is describe in Study flow according to CONSORT recommendations. MICT, moderate intensity continuous training; HIIT, high-intensity interval training; SBP, systolic blood pressure.The was no | PMC9900112 |
Medication record | Medication use was self-reported according to Class of medicines used by patients.HIIT, high-intensity interval training; MICT, moderate intensity continuous training; SGLT2, Sodium glucose cotransporter 2; DPP-4, Dipeptidyl peptidase-4; GLP-1, Glucagon-like peptide-1. | PMC9900112 | ||
Biochemical analyses | At the first visit to the laboratory, 4 mL of whole blood was collected by the vacuum method into EDTA tubes (Plastilab, Brazil) from the antecubital vein after approximately 12 h overnight fasting. Homogenized whole blood was used for preparation and processing of samples.The following analyzes were performed for glucose metabolism: fasting glucose by enzymatic method using commercial kits (Labtest, Brazil), fasting insulin by chemiluminescence and HbA1c by immunoassay. This method is certified by the National Glycohemoglobin Standardization Program (Lipid profile analysis involved total cholesterol by enzymatic system (reaction of the endpoint), HDL by System for direct homogeneous determination of HDL cholesterol in serum, and triglycerides by enzymatic system, by end point reaction, all using commercial kits (Labtest, Brazil). | PMC9900112 | ||
Cardiopulmonary exercise test (CPET) | RPE | HEART | CPET involved an incremental ramp type protocol performed on a treadmill (MicromedAfter warm-up, treadmill speed was set according to age and gender, following the recommendations of the Brazilian Society of Cardiology. The speed was then increased by 0.1 km/h every 10, 20 or 30 seconds until voluntary exhaustion, and participants were verbally encouraged to give their maximum effort. The test lasted between 8 to 12 minutes and ended when participants met the criteria for test interruption according to ACSM guideline (Volunteers were instructed to wear comfortable clothes and avoid vigorous physical exercise (24 hours before the test), alcohol consumption (12 hours before the test) and caffeine (3 hours before the test). CPET was performed in the morning, to avoid the influence of the circadian rhythm. Ambient temperature (22°C - 24°C), relative humidity (40% - 60%) and lighting were controlled according to the preliminary conditions (23). Gas analysis was performed using a CortexHR, BP, rating of perceived exertion (RPE) and ventilatory parameters (peak, carbon dioxide production, respiratory oxygen equivalent, respiratory equivalent of the ventilatory threshold) were monitored and registered during the test. RPE was evaluated according to the Borg 0-10 (27). The instrument presents numerical classification from “0” to “10”, indicating low and maximum intensity effort, respectively. The values indicated by the volunteers were recorded at the end of each minute of the test (5th to 16th minute). Heart rate (HR) was measured by a cardiac monitor (Polar v800, Finland) during the test and up to 10 minutes of rest after its end, with the volunteer in the sitting position. Cardiac monitor was fixed in the chest and with simultaneous transmission to a watch. Data were later transferred and recorded in a specific software (Polar Flow, Finland) for proper analysis. | PMC9900112 |
Exercise protocols | The protocols were customized with individualized monitored of HR, BP and v Exercise session started with a 2 min warm-up and ended with a 2 min cooldown at 50% of v Exercise intensity was adjusted using perceived of exertion as previously suggested ( | PMC9900112 | ||
Statistical analyses | Data normality and homogeneity were tested using the Shapiro-Wilk and Levene test, respectively. Post-training values were compared between groups using analysis of covariance (ANCOVA) with pre-training values as covariates. When a significant effect was identified, All analyses were performed using SPSS statistical package (Statistical Package for Social Sciences Chicago, IL, USA) version 20.0 for Windows. Results are expressed as mean and standard deviation, and the accepted level of significance was (p< 0.05). | PMC9900112 | ||
Results | ±, S-HIIT, high-density lipoprotein | The characteristics of participants are described in Characteristics of participants.BMI, body mass index; training; S-HIIT, short high-intensity interval training; L-HIIT, long high-intensity interval training; MICT, moderate intensity continuous; M, Male; F, Female. Data presented as mean ± standard deviation.There were significant difference between groups for changes on Comparison between and within groups for dependent variables.MICT, moderate intensity continuous training; L-HIIT, long high intensity interval training; S-HIIT, short high intensity interval training; HbA1c, glycated hemoglobin; HDL, high-density lipoprotein; LDL, low-density lipoprotein; SBP, systolic blood pressure; DBP, diastolic blood pressure; HR, heart rate; * L-HIIT > MICT.# S-HIIT > MICT.Bold values mean p<0.05.In comparison with pre-training values, there was a significant reduction on HbA1c levels for L-HIIT (mean difference [MD] = -1.8 ± 1.8%, p< 0.01), while no significant change was achieved for S-HIIT (MD = -0.92 ± 2.0%, p = 0.09) and MICT (MD = -0.59 ± 1.7%, p = 0.2). Triglycerides levels significantly reduced after L-HIIT (MD = -23.80 ± 39.6 mg/dL, p = 0.04), with no changes for S-HIIT (MD = -23.19 ± 49.0 mg/dL, p = 0.09) and MICT (MD = 5.36 ± 31.9 mg/dL, p = 0.5). There were no significant changes from pre- to post-training on fasting glycemia, total cholesterol, HDL, and LDL (p > 0.05).There was a significant reduction on resting SBP for L-HIIT group (MD = -12.07 ± 15.3 mmHg, p< 0.01), but not for S-HIIT (MD = -7.33 ± 17.1 mmHg, p = 0.1) and MICT (MD = 4.43 ± 13.1 mmHg, p = 0.2). | PMC9900112 | |
Discussion | S-HIIT, reductions in cardiovascular events, BP reductions, T2DM, dyslipidemia | CARDIOVASCULAR DISEASES, DYSLIPIDEMIA | The present study investigated the effects of three aerobic training protocols (L- HIIT, S-HIIT, and MICT) on cardiometabolic parameters of patients with T2DM. The recommendation of a minimum of 150 min per week of moderate intensity physical activities for blood glucose control and cardiovascular health is still predominant (Previous studies have shown 15 to 20% reductions in cardiovascular events when HbA1c is reduced by 1% (Although no significant difference was found for lipid profile between groups, there was a trend to decrease triglycerides and a large effect was found between pre and post intervention for both HIIT protocols [L-HIIT [-0.57 (wide)]; S-HIIT [-0.53 (wide)]. It is important to acknowledge that improvements in triglyceride and HDL levels are important due to the associations between dyslipidemia and cardiovascular diseases (L-HIIT showed a greater reduction in resting SBP when compared to MICT (p = 0.018; d = 1.56 [large effect]). Although several studies have shown BP reductions through exercises (One important limitation of the present study is the absence of dietary control. However, participants were oriented to not change their diet. We believe that these limitations do not prevent the conclusions of the study from being elaborated. In addition, due the lack of control group, it was not possible to know whether changes observed for exercising groups were different when compared to non-exercise conditions. | PMC9900112 |
Conclusion | Low-volume HIIT promoted greater improvements in cardiorespiratory capacity in comparison with low-volume MICT, independent of the protocols used. There were no other difference between groups. All protocols improved at least one of the variables analyzed; however, the most evident benefits were after the high-intensity protocols, especially L-HIIT. Therefore, it will be up to the professional to analyze their patients individually to propose the best intervention for each case, within an appropriate cost-benefit perspective. | PMC9900112 | ||
Data availability statement | The raw data supporting the conclusions of this article will be made available by the authors, under reasonable request. | PMC9900112 | ||
Ethics statement | The studies involving human participants were reviewed and approved by Federal University of Goias Ethics Committee. The patients/participants provided their written informed consent to participate in this study. | PMC9900112 | ||
Author contributions | PG conceived and designed the research. LS, JC, and JSC performed experiments. DS and PG analyzed data, interpreted results of experiments, and drafted manuscript. DS and AR edited and revised manuscript. All authors contributed to the article and approved the submitted version. | PMC9900112 | ||
Acknowledgments | We would like to thank all participants who volunteered their time to participate in the study. | PMC9900112 | ||
Conflict of interest | The 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. | PMC9900112 | ||
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. | PMC9900112 | ||
References | PMC9900112 | |||
Subject terms | sepsis, septic | ADVERSE EVENTS, SEPSIS | Patients with sepsis often require emergency intubation. In emergency departments (EDs), rapid-sequence intubation with a single-dose induction agent is standard practice, but the best choice of induction agent in sepsis remains controversial. We conducted a randomized, controlled, single-blind trial in the ED. We included septic patients who were aged at least 18 years and required sedation for emergency intubation. Patients were randomly assigned by a blocked randomization to receive 0.2–0.3 mg/kg of etomidate or 1–2 mg/kg of ketamine for intubation. The objectives were to compare the survival outcomes and adverse events after intubation between etomidate and ketamine. Two hundred and sixty septic patients were enrolled; 130 patients/drug arm whose baseline characteristics were well balanced at baseline. In the etomidate group, 105 patients (80.8%) were alive at 28 days, compared with 95 patients (73.1%) in the ketamine group (risk difference [RD], 7.7%; 95% confidence interval [CI], − 2.5 to 17.9%; P = 0.092). There was no significant difference in the proportion of patients who survived at 24 h (91.5% vs. 96.2%; P = 0.097) and survived at 7 days (87.7% vs. 87.7%; P = 0.574). A significantly higher proportion of the etomidate group needed a vasopressor within 24 h after intubation: 43.9% vs. 17.7%, RD, 26.2% (95% CI, 15.4 to 36.9%; P < 0.001). In conclusion, there were no differences in early and late survival rates between etomidate and ketamine. However, etomidate was associated with higher risks of early vasopressor use after intubation. Trial registration: The trial protocol was registered in the Thai Clinical Trials Registry (identification number: TCTR20210213001). Registered 13 February 2021—Retrospectively registered, | PMC10115773 |
Introduction | sepsis, Sepsis | SEPSIS, SEPSIS | Sepsis is a major medical emergency in emergency departments (EDs) and has a high rate of morbidity and mortalityEtomidate is a nonbarbiturate hypnotic that is most often used in RSIKetamine is an alternative induction agent in sepsis. It increases blood pressure and heart rate through catecholamine release and is considered a safe and valuable alternative to etomidate for emergency intubation in patients with sepsisThere is no consensus on which induction agent is preferred for emergency intubation in sepsis. A recent meta-analysis suggested that single-dose etomidate, compared to alternative induction agents, was not associated with increased mortality in patients with sepsis. However, the finding might be subject to bias and confounding | PMC10115773 |
Methods | PMC10115773 | |||
Trial design and oversight | EMERGENCY | From March 2019 to December 2020, this single-centre, randomized, single-blind, controlled trial, with 1:1 allocation, was conducted by the Emergency Medicine Research Group at Thammasat University Hospital (TUH) in Pathum Thani, Thailand. TUH is an 800-bed tertiary academic teaching hospital in the suburbs north of Bangkok, with approximately 1.1 million people living in the area. The ED of TUH sees 60,000 patients annually, and approximately 500 patients need emergency intubation each year. A previous study showed a very high success rate of emergency intubation overall and at the first attempt rate in the ED of TUH (99.4% and 74.7%, respectively) | PMC10115773 | |
Ethics approval and consent to participate | The trial was approved by the Human Research Ethics Committee of the Faculty of Medicine of Thammasat University. Because of the sudden and life-threatening nature of cases in patients who needed emergency intubation, the process of obtaining written informed consent was deferred until after the emergency had passed. We sought written informed consent as soon as practicable after the intubation had passed to continue data collection from the patient or, if the patient was unable to give consent, a patient’s legally authorized representative was informed and gave consent for participation in the research. If the patient regain or develop the capacity to consent, then the patient consent was obtained before any further data collection. All experiments were performed in accordance with approved clinical trial protocols and regulations. | PMC10115773 | ||
Trial registration | The trial protocol was registered in the Thai Clinical Trials Registry (identification number; TCTR20210213001). Registered 13 February 2021—Retrospectively registered, | PMC10115773 | ||
Patient population | sepsis, hypertension, cardiac arrest | ADRENAL INSUFFICIENCY, SEPSIS, HYPERTENSION, CARDIAC ARREST | Patients presenting to the ED with suspected sepsis who were 18 years or older and then needed an induction agent for emergency intubation in the ED were eligible for inclusion. Exclusion criteria were as follows: (1) cardiac arrest before intubation, (2) presence of a do-not-resuscitate order, (3) known or suspected adrenal insufficiency, (4) severe hypertension (blood pressure before randomization: over 180/110 mmHg), and (5) suspected or evidenced increased intracranial pressure. There were no exclusions after application of the randomization criteria in the trial. | PMC10115773 |
Randomization and treatment | sepsis, Sepsis, Septic Shock | SEPSIS, SEPSIS, RSI, SEPTIC SHOCK | Patients were randomly assigned to receive a single-dose induction agent consisting of either etomidate (Lipuro, B. Braun Melsungen, Germany) administered as a 0.2–0.3 mg/kg intravenous bolus or ketamine (Ketalar, PAR Pharmaceutical, Ireland) administered as a 1–2 mg/kg intravenous bolus. The randomization sequence was determined using a computer-generated randomization table with a block size of four by a statistician who was not involved in determining the patient eligibility, drug administration, intubating procedure, or outcome assessment. The drug allocation sequence was kept inaccessible to the research team throughout the study period. Patient assignments were placed into sequentially numbered sealed opaque envelopes. The emergency physician enrolling patients was responsible for opening these envelopes and preparing the study agent but was not involved in the intubation process. None of the emergency physicians enrolling patients were members of the staff in the inpatient ward, and they had no influence on the management of the patients after they were admitted to the hospital.All patients received the same standard RSI protocol, except for the single-dose induction agent. The use of a neuromuscular blocking agent immediately after induction (succinylcholine as a 1.5 mg/kg intravenous bolus) depended on the clinical state of the patient and the presence of any contraindications. Patients were intubated by either the direct laryngoscopy technique (Macintosh) or video laryngoscopy technique (GlideScope). Intratracheal tube positioning was confirmed by clinical assessments and capnometers with capnographs.The definition of sepsis was based on the Third International Consensus Definitions for Sepsis and Septic Shock | PMC10115773 |
Outcomes | peri-intubation adverse, hypotension, cardiac arrest | ADVERSE EVENTS, SECONDARY, CARDIAC ARREST | The primary outcome was 28-day survival. The secondary outcomes were 24-h survival, 7-day survival, early haemodynamic parameters after intubation, amount of fluid required in the first three hours, and occurrence of peri-intubation adverse events. Peri-intubation adverse events included cardiac arrest (during or immediately after intubation), failed intubation, postintubation hypotension (systolic blood pressure below 90 mmHg, or mean arterial blood pressure below 65 mmHg), and use of a vasopressor (norepinephrine, epinephrine, or dopamine) within the first 24 h after intubation. Outcomes were assessed by trained research coordinators who were unaware of treatment assignment. | PMC10115773 |
Sample size estimation | A pilot study was performed to obtain the preliminary data for the calculation of a sample size for the primary outcome. Our power was determined by the survival rate of the pilot population. We determined that a group of 130 patients in the etomidate allocation and a group of 130 patients in the ketamine allocation were needed to detect ten percent absolute risk differences with 80% power and a type-I error of 0.05. | PMC10115773 | ||
Statistical analysis | The independent data monitoring committee performed an interim analysis every 6 months. We used the Haybittle-Peto boundary to determine the upper and lower stopping boundaries for the primary outcome, with no adjustment in the final analysis.The survival outcomes were analysed without adjustment in the intention-to-treat population, which included all the patients who were randomized. All included patients were confirmed to have received the assigned intervention. Trial data were summarized by the calculation of means and standard deviations for normally distributed variables, median and interquartile ranges for nonnormally distributed variables, and frequency and percentage for categorical variables. The magnitude of the difference between two percentages was demonstrated by the risk difference with 95% confidence intervals. All statistical tests were two-sided. A p value less than 0.05 was considered statistically significant. All analyses were performed using STATA software version 14.0 (StataCorp, College Station, TX). | PMC10115773 | ||
Results | PMC10115773 | |||
Patients and interventions | sepsis | SEPSIS, HIGH BLOOD PRESSURE | A total of 272 suspected sepsis patients who needed an induction agent for emergency intubation were enrolled. 12 patients were excluded because of very high blood pressures before intubation (Fig. Flow diagram of the study patients enrolled.Characteristics of the patients at baseline.Intubation conditions between the two groups were also similar (Table Intubation conditions of the study patients. | PMC10115773 |
Primary and secondary outcomes | postintubation hypotension, peri-intubation adverse, cardiac arrest | SECONDARY, CARDIAC ARREST | In the etomidate group, 105 patients (80.8%) were alive at 28 days compared to 95 patients (73.1%) in the ketamine group (risk difference [RD], 7.7%; 95% confidence interval [CI], − 2.5 to 17.9%; P = 0.092). There were no significant differences between the etomidate group and the ketamine group in the proportion of patients who survived at 24 h (91.5% vs. 96.2%, respectively; RD, 4.7%; 95% CI, − 1.2 to 10.4%; P = 0.097) or survival at 7 days (87.7% vs. 87.7%; RD, 0%; 95% CI, − 7.9 to 7.9%; P = 0.574) (Table Primary and secondary outcomes.Total fluid required in the firstthree hours, median (IQR) mlUsed of a vasopressor medicationwithin 24 h after intubationPrimary and secondary outcomes.Regarding peri-intubation adverse events, cardiac arrest during intubation occurred in two patients (1.5%) in the etomidate group and two patients (1.5%) in the ketamine group (RD, 0%; 95% CI, − 2.9 to 2.9%; P = 1.0). Two patients (1.5%) in the etomidate group, but none in the ketamine group, were diagnosed with failed intubation. There was no significant difference between the study groups in the proportion of patients with postintubation hypotension (11.5% vs. 10.8%; RD, 0.7%; 95% CI, − 6.9 to 8.4%; P = 0.843); however, there were significant differences between the etomidate group and the ketamine group in the proportion of patients who needed a vasopressor within 24 h after intubation (43.9% vs. 17.7%, respectively; RD, 26.2%; 95% CI, 15.4 to 36.9%; P < 0.001) and the proportion of patients who received intravenous corticosteroids (14.6% vs. 5.4%, respectively; RD, 9.2%; 95% CI, 2.1 to 16.4%; P = 0.012) (Table | PMC10115773 |
Discussion | critically ill, peri-intubation adverse, peri-intubation, peri-intubation cardiac arrest, hypotension, ill, sepsis | ADVERSE EVENTS, SEPSIS, CRITICALLY ILL | The main goal of this study was to compare the clinical outcomes between the two induction agents that are most commonly used for emergency intubation in EDs. We found no significant differences in survival at 24 h, 7 days, and 28 days in sepsis patients intubated with etomidate or ketamine. We also found no significant difference in patients’ physiological parameters after intubation and peri-intubation adverse events, including (1) peri-intubation cardiac arrest, (2) failed intubation, and (3) postintubation hypotension. However, there were significant differences between the etomidate group and the ketamine group in the proportion of patients who required a vasopressor within 24 h after intubation and received intravenous corticosteroids.There is controversy regarding the safety of single-dose etomidate as an induction agent for emergency intubation in patients with sepsis. Several RCTs compared mortality outcomes between etomidate and alternative induction agentsEtomidate can suppress the adrenal synthesis of cortisol by inhibiting 11-β hydroxylase, the enzyme responsible for the conversion of 11-deoxycortisol to cortisolPrevious studies comparing etomidate and ketamine in acutely ill patients showed that there were no differences in major peri-intubation adverse events, including peri-intubation cardiac arrest, change in blood pressure after intubation, and the total volume of intravenous fluid needed after intubationSingle-dose induction agents can impact patients’ haemodynamic status, especially in critically ill patients who need emergency intubation. Although both etomidate and ketamine are considered haemodynamically stable induction agents, there remain concerns that they might cause postintubation hypotension, particularly in patients with sepsisMulticentre observational studies have reported that ketamine is associated with higher risks of postintubation hypotension after emergency intubation than alternative agents | PMC10115773 |
Limitations | hypotension | Our study was limited by its sample size, and although our results show no difference in patients’ physiological parameters and postintubation hypotension after a single-dose of etomidate or ketamine, we had limited statistical power. Moreover, we did not calculate the sample size to demonstrate the differences in physiologic parameters in the design phase of the trial. However, our study has provided prospectively collected data on 28-day mortality rates that could be used for future high-quality and adequately powered studies comparing the immediate effects of etomidate and ketamine as well as mortality. | PMC10115773 | |
Conclusions | sepsis | SEPSIS | In patients with clinically suspected sepsis who needed emergency intubation in the ED, there was no difference in early and 28-day survival rates between etomidate and ketamine. However, etomidate was associated with higher risks of early vasopressor use after intubation. | PMC10115773 |
Author contributions | Conceptualization: W.S., A.B., K.A. Protocol development: W.S., K.A. Data collection: A.B., K.D., C.L., K.A., I.I., N.D., I.D., Y.S., T.U., C.P. Data analysis: W.S., A.B. Writing and editing manuscript: W.S., V.P. All authors read and approved the final manuscript. | PMC10115773 | ||
Funding | EMERGENCY | This study is funded by the Research group in Emergency Medicine and Emergency Critical Care of the Faculty of Medicine of Thammasat University. | PMC10115773 | |
Data availability | The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request. | PMC10115773 | ||
Competing interests | The authors declare no competing interests. | PMC10115773 | ||
References | PMC10115773 | |||
Background | depression, anxiety | Growing evidence suggests a role for gut bacteria and their metabolites in host-signaling responses along the gut-brain axis which may impact mental health. Meditation is increasingly utilized to combat stress, anxiety, and depression symptoms. However, its impact on the microbiome remains unclear. This study observes the effects of preparation and participation in an advanced meditation program (Samyama) implemented with a vegan diet including 50% raw foods, on gut microbiome and metabolites profiles. | PMC10074366 | |
Methods | There were 288 subjects for this study. Stool samples were collected at 3-time points for meditators and household controls. Meditators prepared for 2 months for the Samyama, incorporating daily yoga and meditation practices with a vegan diet including 50% raw foods. Subjects were requested to submit stool samples for 3 time points – 2 months before Samyama (T1), right before Samyama (T2), and 3 months following Samyama (T3). 16 s rRNA sequencing was used to study participants' microbiome. Alpha and beta diversities along with short-chain fatty acid (SCFA) were assessed. Metabolomics were performed on a mass spectrometer coupled to a UHLPC system and analyzed by El-MAVEN software. | PMC10074366 | ||
Results | Alpha diversity showed no significant differences between meditators and controls, while beta diversity showed significant changes (padj = 0.001) after Samyama in meditators’ microbiota composition. After the preparation phase, changes in branched short-chain fatty acids, higher levels of iso-valerate (padj = 0.02) and iso-buytrate (padj = 0.019) were observed at T2 in meditators. Other metabolites were also observed to have changed in meditators at timepoint T2. | PMC10074366 | ||
Conclusion | This study examined the impact of an advanced meditation program combined with a vegan diet on the gut microbiome. There was an increase in beneficial bacteria even three months after the completion of the Samyama program. Further study is warranted to validate current observations and investigate the significance and mechanisms of action related to diet, meditation, and microbial composition and function, on psychological processes, including mood. | PMC10074366 | ||
Trial registration | Registration number: | PMC10074366 | ||
Keywords | PMC10074366 | |||
Background | depression, anxiety | Understanding the influence of the gut microbiota on nervous system function is gaining increasing interest from the scientific community [The human gut microbiota influences emotional and psychological states in a bidirectional way. Recent evidence points to the microbiome as part of a neuro-immune-endocrine matrix [Over the past decade, meditation has become an increasingly popular method to address symptoms related to stress, anxiety, and depression. Meditation effectively reduces symptoms associated with anxiety and depression [ | PMC10074366 | |
Materials and methods | PMC10074366 |
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