Effect of an Immune-Boosting, Antioxidant and Anti-Inflammatory Food Supplement in Hospitalized COVID-19 Patients: A Prospective Randomized Pilot Study

Reino-Gelardo et al., Nutrients, doi:10.3390/nu15071736, NCT04666116

Apr 2023

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RCT 162 late stage (65% on oxygen) patients in Spain, 78 treated with probiotics, prebiotics, vitamin D, zinc, and selenium, showing lower mortality with treatment, statistically significant only within the patients with high severity at baeline.

Treatment included bifidobacterium lactis BPL1, lactobacillus rhamnosus CNCM I-4036, bifidobacterium longum ES1, 1.5mg of zinc, 8.25μg of selenium, and 0.75μg of vitamin D.

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Study covers vitamin D, selenium, zinc, and probiotics.

risk of death, 60.5% lower, RR 0.39, p = 0.05, treatment 8 of 67 (11.9%), control 15 of 78 (19.2%), adjusted per study, inverted to make RR<1 favor treatment, odds ratio converted to relative risk.

risk of death, 91.4% lower, RR 0.09, p < 0.001, treatment 1 of 15 (6.7%), control 7 of 9 (77.8%), NNT 1.4, baseline high severity.

Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates

Reino-Gelardo et al., 1 Apr 2023, Randomized Controlled Trial, Spain, peer-reviewed, mean age 68.7, 10 authors, study period 31 March, 2020 - 15 November, 2020, this trial uses multiple treatments in the treatment arm (combined with probiotics, prebiotics, vitamin D, zinc, and selenium) - results of individual treatments may vary, trial NCT04666116 (history).

This Paper Selenium All

Effect of an Immune-Boosting, Antioxidant and Anti-Inflammatory Food Supplement in Hospitalized COVID-19 Patients: A Prospective Randomized Pilot Study

Lianliang Liu, Qixiao Zhai, Sandra Reino-Gelardo, Marta Palop-Cervera, Nieves Aparisi-Valero, Ignac Espinosa-San, Noelia Lozano-Rodríguez, Gonzalo Llop-Furque, Laura Sanchis-Artero, Ernesto Cortés-Castell, Mercedes Rizo-Baeza, Xavier Cortés-Rizo

doi:10.3390/nu15071736

Background: COVID-19 disease is a serious global health problem. Few treatments have been shown to reduce mortality and accelerate time to recovery. The aim of this study was to evaluate the potential effect of a food supplement (probiotics, prebiotics, vitamin D, zinc and selenium) in patients admitted with COVID-19. Methods: A prospective randomized non-blinded clinical trial was conducted in a sample of 162 hospitalized patients diagnosed with COVID-19 recruited over eight months. All patients received standard treatment, but the intervention group (n = 67) was given one food supplement stick daily during their admission. After collecting the study variables, a statistical analysis was performed comparing the intervention and control groups and a multivariate analysis controlling for variables that could act as confounding factors. Results: ROC curve analysis with an area under the curve (AUC) value of 0.840 (p < 0.001; 95%CI: 0.741-0.939) of the food supplement administration vs. recovery indicated good predictive ability. Moreover, the intervention group had a shorter duration of digestive symptoms compared with the control group: 2.6 ± 1.3 vs. 4.3 ± 2.2 days (p = 0.001); patients with non-severe disease on chest X-ray had shorter hospital stays: 8.1 ± 3.9 vs. 11.6 ± 7.4 days (p = 0.007). Conclusions: In this trial, the administration of a food supplement (Gasteel Plus ® ) was shown to be a protective factor in the group of patients with severe COVID-19 and allowed early recovery from digestive symptoms and a shorter hospital stay in patients with a normal-mild-moderate chest X-ray at admission (ClinicalTrials.gov number, NCT04666116).

Supplementary Materials: The following supporting information can be downloaded at: https: //www.mdpi.com/article/10.3390/nu15071736/s1, Figure S1 : ROC curve for evaluation of the potential effect of the food supplement Gasteel as a protector factor in the response. The value of the area under the curve (AUC) indicates the ability of the parameters studied as variable of exitus response; Table S1 : Summary of the main treatment administered during hospitalization of the study population, according the local guide. The p values were obtained with the χ 2 test and the Student's t test; Table S2 . Evolution of the main analytical parameters for recovery evaluation during admission and discharge period; Table S3 . Pharmacological treatment algorithm in the patients recruited from March to April 2020; Table S4 . Pharmacological treatment algorithm in the patients recruited September to November 2020. References [42] [43] [44] [45] [46] [47] are cited in the supplementary materials. Informed Consent Statement: Informed consent was obtained from all subjects involved in this study. Conflicts of Interest: The authors declare no conflict of interest. The authors would like to note that the use of probiotics is only addressed to supplement nutritionally patients with the aim of contributing to their microbiome's recovery.

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Late treatment
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