Effect of Red Beetroot Juice Intake in Adults With Long COVID-19
NCT ID: NCT06535165
Last Updated: 2024-08-05
Study Results
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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COMPLETED
NA
31 participants
INTERVENTIONAL
2021-03-01
2021-07-31
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Red Beetroot Juice
daily oral supplementation with 200 mL beetroot juice for 14 days
Red Beetroot Juice
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
Placebo
200ml/d for 14 days
Interventions
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Red Beetroot Juice
200ml/d for 14 days
Placebo
200ml/d for 14 days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
60 Years
ALL
No
Sponsors
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Catholic University of the Sacred Heart
OTHER
Responsible Party
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Francesco Landi
MD
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
Countries
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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.
Other Identifiers
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5110
Identifier Type: -
Identifier Source: org_study_id
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