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

Effect of 14-day Red Beetroot Juice Intake on Physical Function, Gut Microbiota Composition, and Systemic Inflammation 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

Study Overview

• Status: Completed
• Conditions: Long COVID
• Intervention / Treatment: Dietary supplement: Red Beetroot Juice; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00168
    • Center for Aging and Geriatrics Research - UCSC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Red Beetroot Juice; daily oral supplementation with 200 mL beetroot juice for 14 days	Dietary supplement: Red Beetroot Juice; 200ml/d for 14 days
Placebo Comparator: Control; Placebo (a solution containing 7 g of sugar, 180 mL of water, and 20 mL of beetroot juice, to show the same color as the active treatment) for 14 days	Other: Placebo; 200ml/d for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatigue resistance	The time (in seconds) when the pressure dropped to 50% of the maximum grip strength	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Six-minute walk test	The distance walked (in meters) on the 6-min walk test	14 days
Flow-mediated dilation	the dilation of the brachial artery after a transitory bout of forearm ischemia	14 days
Fecal water metabolomics	Changes in fecal water metabolomics by nuclear magnetic resonance (NMR) spectroscopy	14 days
Changes in the concentration of gut microbial species	Changes in the concentration of gut microbial species as assessed through 16S rRNA analysis	14 days
Changes in the concentration of circulating inflammatory mediators	Changes in the concentration of circulating cytokines, chemokines, growth factors, extracellular vesicles	14 days

Collaborators and Investigators

• Sponsor: Catholic University of the Sacred Heart
• Investigators: Principal Investigator: Francesco Landi, MD, Catholic University of the Sacred Heart

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): July 31, 2021
• Study Completion (Actual): July 31, 2021

Study Registration Dates

• First Submitted: August 1, 2024
• First Submitted That Met QC Criteria: August 1, 2024
• First Posted (Actual): August 2, 2024

Study Record Updates

• Last Update Posted (Estimated): August 5, 2024
• Last Update Submitted That Met QC Criteria: August 2, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; Chronic Disease; Post-Infectious Disorders; COVID-19; Post-Acute COVID-19 Syndrome
• Other Study ID Numbers: 5110

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No