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

NCT ID: NCT06535165

Last Updated: 2024-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2021-07-31

Brief Summary

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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

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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.

Conditions

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Long COVID

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Red Beetroot Juice

daily oral supplementation with 200 mL beetroot juice for 14 days

Group Type EXPERIMENTAL

Red Beetroot Juice

Intervention Type DIETARY_SUPPLEMENT

200ml/d for 14 days

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

200ml/d for 14 days

Interventions

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Red Beetroot Juice

200ml/d for 14 days

Intervention Type DIETARY_SUPPLEMENT

Placebo

200ml/d for 14 days

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Catholic University of the Sacred Heart

OTHER

Sponsor Role lead

Responsible Party

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Francesco Landi

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Francesco Landi, MD

Role: PRINCIPAL_INVESTIGATOR

Catholic University of the Sacred Heart

Locations

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Center for Aging and Geriatrics Research - UCSC

Rome, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 39571342 (View on PubMed)

Other Identifiers

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5110

Identifier Type: -

Identifier Source: org_study_id

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