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OpenTrials
Completed

NCT Number: NCT06535165

Effect of Red Beetroot Juice Intake in Adults With Long COVID-19

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Red Beetroot Juice

Dietary Supplement

200ml/d for 14 days

Placebo

Other

200ml/d for 14 days

Primary outcomes

  1. Fatigue resistance

    Time frame: 14 days

    The time (in seconds) when the pressure dropped to 50% of the maximum grip strength

Secondary outcomes

  1. Six-minute walk test

    Time frame: 14 days

    The distance walked (in meters) on the 6-min walk test

  2. Flow-mediated dilation

    Time frame: 14 days

    the dilation of the brachial artery after a transitory bout of forearm ischemia

  3. Changes in the concentration of gut microbial species

    Time frame: 14 days

    Changes in the concentration of gut microbial species as assessed through 16S rRNA analysis

  4. Fecal water metabolomics

    Time frame: 14 days

    Changes in fecal water metabolomics by nuclear magnetic resonance (NMR) spectroscopy

  5. Changes in the concentration of circulating inflammatory mediators

    Time frame: 14 days

    Changes in the concentration of circulating cytokines, chemokines, growth factors, extracellular vesicles

Sponsors and collaborators

Lead sponsor

Catholic University of the Sacred Heart

Other

Registry information

Official study title

Effect of 14-day Red Beetroot Juice Intake on Physical Function, Gut Microbiota Composition, and Systemic Inflammation in Adults With Long COVID-19

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 2, 2024
Registry last updated
Aug 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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