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

NCT06535165 | Completed

• 1 other identifier: 5110
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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

Conditions

Long COVID

Outcome Measures

Primary Outcomes (1)

• Fatigue resistance

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

  14 days

Secondary Outcomes (5)

• Six-minute walk test

  14 days

• Flow-mediated dilation

  14 days

• Changes in the concentration of gut microbial species

  14 days

• Fecal water metabolomics

  14 days

• Changes in the concentration of circulating inflammatory mediators

  14 days

Study Arms (2)

Red Beetroot Juice

EXPERIMENTAL

daily oral supplementation with 200 mL beetroot juice for 14 days

Dietary Supplement: Red Beetroot Juice

Control

PLACEBO COMPARATOR

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

Interventions

Red Beetroot Juice DIETARY_SUPPLEMENT

200ml/d for 14 days

Red Beetroot Juice

Placebo OTHER

200ml/d for 14 days

Control

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

Center for Aging and Geriatrics Research - UCSC

Rome, 00168, Italy

Location

Related Publications (1)

• Calvani R, Giampaoli O, Marini F, Del Chierico F, De Rosa M, Conta G, Sciubba F, Tosato M, Picca A, Ciciarello F, Galluzzo V, Gervasoni J, Di Mario C, Santoro L, Tolusso B, Spagnoli M, Tomassini A, Aureli W, Toto F, Pane S, Putignani L, Miccheli A, Marzetti E, Landi F; Gemelli against COVID-19 Post-Acute Care Team. Beetroot juice intake positively influenced gut microbiota and inflammation but failed to improve functional outcomes in adults with long COVID: A pilot randomized controlled trial. Clin Nutr. 2024 Dec;43(12):344-358. doi: 10.1016/j.clnu.2024.11.023. Epub 2024 Nov 14.

  PMID: 39571342 DERIVED

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Francesco Landi, MD

  Catholic University of the Sacred Heart

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: August 2, 2024
• Study Start: March 1, 2021
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: August 5, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)