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

  • 2023-04-01
  • Nutrients 15(7)
    • 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

Study Design

Type
Randomized Controlled Trial (RCT)
Population
162 hospitalized patients diagnosed with COVID-19
Methods
Prospective randomized non-blinded clinical trial; all patients received standard treatment, intervention group given one food supplement stick daily during admission
Blinding
Open-label
Duration
during their admission (eight months recruitment)
Funding
Unclear
  • Rigorous Journal

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).

Research Insights

  • Selenium→Improved Recovery

    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

    Effect
    Beneficial
    Effect size
    Small
    Dose
    one food supplement stick daily
  • Selenium→Reduced Duration of Digestive Symptoms

    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)

    Effect
    Beneficial
    Effect size
    Large
    Dose
    one food supplement stick daily
  • Selenium→Reduced Hospital Stay

    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)

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    one food supplement stick daily
  • Vitamin D→Improved Recovery

    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

    Effect
    Beneficial
    Effect size
    Small
    Dose
    one food supplement stick daily
  • Vitamin D→Reduced Duration of Digestive Symptoms

    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)

    Effect
    Beneficial
    Effect size
    Large
    Dose
    one food supplement stick daily
  • Vitamin D→Reduced Hospital Stay

    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)

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    one food supplement stick daily
  • Zinc→Improved Recovery

    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

    Effect
    Beneficial
    Effect size
    Small
    Dose
    one food supplement stick daily
  • Zinc→Reduced Duration of Digestive Symptoms

    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)

    Effect
    Beneficial
    Effect size
    Large
    Dose
    one food supplement stick daily
  • Zinc→Reduced Hospital Stay

    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)

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    one food supplement stick daily
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