Long COVID
Conditions
Brief summary
Red beetroot juice may have positive effects on multiple pathways involved in long COVID. The aim of this pilot study was to explore the impact of beetroot juice supplementation on physical function, gut microbiota, and systemic inflammation in adults with long-COVID
Detailed description
A single-center, double-blind, placebo-controlled randomized trial to test the effects of 14 days of beetroot juice supplementation on functional and biological outcomes in adults with long-COVID. Participants were randomized 1:1 to receive either daily oral supplementation with 200 mL beetroot juice or placebo for 14 days. The primary endpoint was the change from baseline to day 14 in the fatigue resistance test. Secondary outcomes included the distance walked on the 6-min walk test, handgrip strength, and flow-mediated dilation. Secondary endpoints also included changes from baseline in circulating inflammatory mediators, metagenomic and fecal water metabolomic profiles. Partial least squares discriminant analysis (PLS-DA) models were built to evaluate the differences in biological variables associated with the interventions.
Interventions
DIETARY_SUPPLEMENTRed Beetroot Juice
200ml/d for 14 days
OTHERPlacebo
200ml/d for 14 days
Sponsors
Catholic University of the Sacred Heart
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* a certification of a previous SARS-CoV-2 infection * a negative COVID-19 swab test at least four weeks prior to the screening visit * meet the criteria for long-COVID diagnosis according to the World Health Organization criteria * report persistent fatigue
Exclusion criteria
* intolerance to beetroot juice or its derivatives * clinical conditions and/or use of medications that may interfere with trial outcomes (e.g., pregnancy or breastfeeding, diabetes, use of steroids or non-steroidal anti-inflammatory drugs, immunosuppressants, nitrates) * participation in other intervention trials for long-COVID
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue resistance | 14 days | The time (in seconds) when the pressure dropped to 50% of the maximum grip strength |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Six-minute walk test | 14 days | The distance walked (in meters) on the 6-min walk test |
| Flow-mediated dilation | 14 days | the dilation of the brachial artery after a transitory bout of forearm ischemia |
| Changes in the concentration of gut microbial species | 14 days | Changes in the concentration of gut microbial species as assessed through 16S rRNA analysis |
| Fecal water metabolomics | 14 days | Changes in fecal water metabolomics by nuclear magnetic resonance (NMR) spectroscopy |
| Changes in the concentration of circulating inflammatory mediators | 14 days | Changes in the concentration of circulating cytokines, chemokines, growth factors, extracellular vesicles |
Countries
Italy
Outcome results
None listed