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

Not Applicable

Completed

• Conditions: Long COVID
• Interventions: Other: Placebo; Dietary Supplement: Red Beetroot Juice

• Registration Number: NCT06535165
• Lead Sponsor: Catholic University of the Sacred Heart

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.

Study Timeline

• Study Start: 2021-03-01
• Primary Completion: 2021-07-31
• Study Completion: 2021-07-31
• Status Verified: 2024-08
• Study First Submitted: 2024-08-01
• Study First Submitted QC: 2024-08-01
• Study First Posted: 2024-08-02
• Last Update Submitted: 2024-08-02
• Last Update Posted: 2024-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Placebo	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
Red Beetroot Juice	Red Beetroot Juice	daily oral supplementation with 200 mL beetroot juice for 14 days

Primary Outcome Measures

Name	Time	Method
Fatigue resistance	14 days	The time (in seconds) when the pressure dropped to 50% of the maximum grip strength

Secondary Outcome Measures

Name	Time	Method
Changes in the concentration of gut microbial species	14 days	Changes in the concentration of gut microbial species as assessed through 16S rRNA analysis
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 circulating inflammatory mediators	14 days	Changes in the concentration of circulating cytokines, chemokines, growth factors, extracellular vesicles
Fecal water metabolomics	14 days	Changes in fecal water metabolomics by nuclear magnetic resonance (NMR) spectroscopy

Trial Locations

Locations (1)

Center for Aging and Geriatrics Research - UCSC; 🇮🇹 Rome, Italy