Regular Consumption of Cocoa and Red Berries as a Strategy to Improve Cardiovascular Biomarkers via Modulation of Microbiota Metabolism in Healthy Aging Adults

The aim of the present study was to analyze the effects of cocoa flavanols and red berry anthocyanins on cardiovascular biomarkers, such as homocysteine, angiotensin-converting enzyme (ACE), nitric oxide (NO), flow-mediated vasodilation (FMD), blood pressure and lipid profile. Additionally, we aimed to ascertain their possible interactions with microbiota related metabolites, such as secondary bile acids (SBA), short-chain fatty acids (SCFA) and trimethylamine N-oxide (TMAO). A randomized, parallel-group study, single-blind for the research team, was performed on 60 healthy volunteers between the ages of 45 and 85, who consumed 2.5 g/day of cocoa powder (9.59 mg/day of total flavanols), 5 g/day of a red berry mixture (13.9 mg/day of total anthocyanins) or 7.5 g/day of a combination of both for 12 weeks. The group that had consumed cocoa showed a significant reduction in TMAO (p = 0.03) and uric acid (p = 0.01) levels in serum, accompanied by an increase in FMD values (p = 0.03) and total polyphenols. corrected by creatinine (p = 0.03) after the intervention. These latter values negatively correlated with the TMAO concentration (R = −0.57, p = 0.02). Additionally, we observed an increase in carbohydrate fermentation in the groups that had consumed cocoa (p = 0.04) and red berries (p = 0.04) between the beginning and the end of the intervention. This increase in carbohydrate fermentation was correlated with lower levels of TC/HDL ratio (p = 0.01), systolic (p = 0.01) and diastolic blood pressure (p = 0.01). In conclusion, our study showed a positive modulation of microbiota metabolism after a regular intake of cocoa flavanols and red berry anthocyanins that led to an improvement in cardiovascular function, especially in the group that consumed cocoa

Regular Consumption of Cocoa and Red Berries as a Strategy to Improve Cardiovascular Biomarkers via Modulation of Microbiota Metabolism in Healthy Aging Adults

The aim of the present study was to analyze the effects of cocoa flavanols and red berry anthocyanins on cardiovascular biomarkers, such as homocysteine, angiotensin-converting enzyme (ACE), nitric oxide (NO), flow-mediated vasodilation (FMD), blood pressure and lipid profile. Additionally, we aimed to ascertain their possible interactions with microbiota related metabolites, such as secondary bile acids (SBA), short-chain fatty acids (SCFA) and trimethylamine N-oxide (TMAO). A randomized, parallel-group study, single-blind for the research team, was performed on 60 healthy volunteers between the ages of 45 and 85, who consumed 2.5 g/day of cocoa powder (9.59 mg/day of total flavanols), 5 g/day of a red berry mixture (13.9 mg/day of total anthocyanins) or 7.5 g/day of a combination of both for 12 weeks. The group that had consumed cocoa showed a significant reduction in TMAO (p = 0.03) and uric acid (p = 0.01) levels in serum, accompanied by an increase in FMD values (p = 0.03) and total polyphenols. corrected by creatinine (p = 0.03) after the intervention. These latter values negatively correlated with the TMAO concentration (R = −0.57, p = 0.02). Additionally, we observed an increase in carbohydrate fermentation in the groups that had consumed cocoa (p = 0.04) and red berries (p = 0.04) between the beginning and the end of the intervention. This increase in carbohydrate fermentation was correlated with lower levels of TC/HDL ratio (p = 0.01), systolic (p = 0.01) and diastolic blood pressure (p = 0.01). In conclusion, our study showed a positive modulation of microbiota metabolism after a regular intake of cocoa flavanols and red berry anthocyanins that led to an improvement in cardiovascular function, especially in the group that consumed cocoa

Predicting 30-Day Readmission Risk for Patients With Chronic Obstructive Pulmonary Disease Through a Federated Machine Learning Architecture on Findable, Accessible, Interoperable, and Reusable (FAIR) Data: Development and Validation Study

BackgroundOwing to the nature of health data, their sharing and reuse for research are limited by legal, technical, and ethical implications. In this sense, to address that challenge and facilitate and promote the discovery of scientific knowledge, the Findable, Accessible, Interoperable, and Reusable (FAIR) principles help organizations to share research data in a secure, appropriate, and useful way for other researchers. ObjectiveThe objective of this study was the FAIRification of existing health research data sets and applying a federated machine learning architecture on top of the FAIRified data sets of different health research performing organizations. The entire FAIR4Health solution was validated through the assessment of a federated model for real-time prediction of 30-day readmission risk in patients with chronic obstructive pulmonary disease (COPD). MethodsThe application of the FAIR principles on health research data sets in 3 different health care settings enabled a retrospective multicenter study for the development of specific federated machine learning models for the early prediction of 30-day readmission risk in patients with COPD. This predictive model was generated upon the FAIR4Health platform. Finally, an observational prospective study with 30 days follow-up was conducted in 2 health care centers from different countries. The same inclusion and exclusion criteria were used in both retrospective and prospective studies. ResultsClinical validation was demonstrated through the implementation of federated machine learning models on top of the FAIRified data sets from different health research performing organizations. The federated model for predicting the 30-day hospital readmission risk was trained using retrospective data from 4.944 patients with COPD. The assessment of the predictive model was performed using the data of 100 recruited (22 from Spain and 78 from Serbia) out of 2070 observed (records viewed) patients during the observational prospective study, which was executed from April 2021 to September 2021. Significant accuracy (0.98) and precision (0.25) of the predictive model generated upon the FAIR4Health platform were observed. Therefore, the generated prediction of 30-day readmission risk was confirmed in 87% (87/100) of cases. ConclusionsImplementing a FAIR data policy in health research performing organizations to facilitate data sharing and reuse is relevant and needed, following the discovery, access, integration, and analysis of health research data. The FAIR4Health project proposes a technological solution in the health domain to facilitate alignment with the FAIR principles

Subcutaneous anti-COVID-19 hyperimmune immunoglobulin for prevention of disease in asymptomatic individuals with SARS-CoV-2 infection: a double-blind, placebo-controlled, randomised clinical trialResearch in context

Summary: Background: Anti-COVID-19 hyperimmune immunoglobulin (hIG) can provide standardized and controlled antibody content. Data from controlled clinical trials using hIG for the prevention or treatment of COVID-19 outpatients have not been reported. We assessed the safety and efficacy of subcutaneous anti-COVID-19 hyperimmune immunoglobulin 20% (C19-IG20%) compared to placebo in preventing development of symptomatic COVID-19 in asymptomatic individuals with SARS-CoV-2 infection. Methods: We did a multicentre, randomized, double-blind, placebo-controlled trial, in asymptomatic unvaccinated adults (≥18 years of age) with confirmed SARS-CoV-2 infection within 5 days between April 28 and December 27, 2021. Participants were randomly assigned (1:1:1) to receive a blinded subcutaneous infusion of 10 mL with 1 g or 2 g of C19-IG20%, or an equivalent volume of saline as placebo. The primary endpoint was the proportion of participants who remained asymptomatic through day 14 after infusion. Secondary endpoints included the proportion of individuals who required oxygen supplementation, any medically attended visit, hospitalisation, or ICU, and viral load reduction and viral clearance in nasopharyngeal swabs. Safety was assessed as the proportion of patients with adverse events. The trial was terminated early due to a lack of potential benefit in the target population in a planned interim analysis conducted in December 2021. ClinicalTrials.gov registry: NCT04847141. Findings: 461 individuals (mean age 39.6 years [SD 12.8]) were randomized and received the intervention within a mean of 3.1 (SD 1.27) days from a positive SARS-CoV-2 test. In the prespecified modified intention-to-treat analysis that included only participants who received a subcutaneous infusion, the primary outcome occurred in 59.9% (91/152) of participants receiving 1 g C19-IG20%, 64.7% (99/153) receiving 2 g, and 63.5% (99/156) receiving placebo (difference in proportions 1 g C19-IG20% vs. placebo, −3.6%; 95% CI -14.6% to 7.3%, p = 0.53; 2 g C19-IG20% vs placebo, 1.1%; −9.6% to 11.9%, p = 0.85). None of the secondary clinical efficacy endpoints or virological endpoints were significantly different between study groups. Adverse event rate was similar between groups, and no severe or life-threatening adverse events related to investigational product infusion were reported. Interpretation: Our findings suggested that administration of subcutaneous human hyperimmune immunoglobulin C19-IG20% to asymptomatic individuals with SARS-CoV-2 infection was safe but did not prevent development of symptomatic COVID-19. Funding: Grifols