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

Sandra Reino-Gelardo, Marta Palop-Cervera, Nieves Aparisi-Valero, Ignacio Espinosa-San Miguel, Noelia Lozano-Rodríguez, Gonzalo Llop-Furquet, Laura Sanchis-Artero, Ernesto Cortés-Castell, Mercedes Rizo-Baeza, Xavier Cortés-Rizo

Journal: Nutrients 2023;15(7):1736

PMID: 37049576

Plain Language Summary

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Coronavirus Disease 2019 (COVID-19), has spread worldwide, reaching pandemic proportions. The symptoms caused by COVID-19 disease are nonspecific and may range from asymptomatic to severe pneumonia and death. 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. This study was a prospective, randomised, non-blinded clinical trial. A total of 162 patients were enrolled at Sagunto Hospital, 42.0% of whom were women. Participants were assigned to one of the two groups: probiotic or control group. Results showed that higher mortality was found in men, older patients and those with severe radiological involvement. Furthermore, administration of the food supplement product Gasteel Plus®, as an adjuvant to the treatment established in the hospital for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-associated pneumonia, reduced the duration of digestive symptoms and hospital stay in patients with mild–moderate pulmonary involvement. Authors conclude that their findings demonstrate the importance of considering the use of the food supplement under review in the prevention and treatment of SARS-CoV-2, including severe cases, which showed no side effects.

Abstract

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 ( = 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 ( < 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 ( = 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 ( = 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).

Address: Internal Medicine Department, Hospital of Sagunto, 46520 Sagunto, Spain.; Clinical Analysis and Microbiology Service, Hospital of Sagunto, 46520 Sagunto, Spain.; Department of Pharmacology, Pediatrics and Organic Chemistry, Miguel Hernández University, 03690 Alicante, Spain.; Department of Nursing, University of Alicante, 03690 Alicante, Spain.; Department of Medicine, Cardenal Herrera-CEU University, 46520 Valencia, Spain.

Patient Centred Factor

Laboratory Testing

Modifiable Lifestyle Factors

Jadad Score

Allocation Concealment

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