Long COVIDNCT06535165
Effect of Red Beetroot Juice Intake in Adults With Long COVID-19
A study testing Red Beetroot Juice in people with Long COVID, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Long COVID
- What is being tested?
- Red Beetroot Juice
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2021to 31 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Long COVID
- Being tested
- Red Beetroot Juice, Placebo
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red Beetroot JuiceDietary supplement
200ml/d for 14 days
PlaceboOther
200ml/d for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Red Beetroot Juice | Experimental | daily oral supplementation with 200 mL beetroot juice for 14 days Receives: 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 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue resistance
The time (in seconds) when the pressure dropped to 50% of the maximum grip strength
Measured: 14 days
Secondary outcomes (5)
Six-minute walk test
The distance walked (in meters) on the 6-min walk test
Measured: 14 days
Flow-mediated dilation
the dilation of the brachial artery after a transitory bout of forearm ischemia
Measured: 14 days
Changes in the concentration of gut microbial species
Changes in the concentration of gut microbial species as assessed through 16S rRNA analysis
Measured: 14 days
Fecal water metabolomics
Changes in fecal water metabolomics by nuclear magnetic resonance (NMR) spectroscopy
Measured: 14 days
Changes in the concentration of circulating inflammatory mediators
Changes in the concentration of circulating cytokines, chemokines, growth factors, extracellular vesicles
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start1 Mar 2021
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Long COVIDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Landi, Catholic University of the Sacred Heart
- Investigators
- Francesco Landi, MD, Principal investigator, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06535165
- Sponsor's protocol ID
- 5110
- Status last verified
- Aug 2024
- First submitted
- 1 Aug 2024
- Last updated
- 5 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39571342
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 14-day Red Beetroot Juice Intake on Physical Function, Gut Microbiota Composition, and Systemic Inflammation in Adults With Long COVID-19
- ClinicalTrials.gov ID
- NCT06535165
- Acronym / sponsor ID
- 5110
- Conditions
- Long COVID
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 2 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Red Beetroot Juice | Experimental | Dietary Supplement: Red Beetroot Juicedaily oral supplementation with 200 mL beetroot juice for 14 days |
| Control | Placebo comparator | Other: PlaceboPlacebo (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 |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Red Beetroot Juice200ml/d for 14 days | Dietary supplement | Red Beetroot Juice |
| Placebo200ml/d for 14 days | Other | Control |
Primary outcome
Fatigue resistance
Time frame: 14 days
The time (in seconds) when the pressure dropped to 50% of the maximum grip strength
5 secondary outcomes
Six-minute walk test
Time frame: 14 days
Flow-mediated dilation
Time frame: 14 days
Changes in the concentration of gut microbial species
Time frame: 14 days
Fecal water metabolomics
Time frame: 14 days
Changes in the concentration of circulating inflammatory mediators
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
- Derived from this study: PubMed 39571342Calvani 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.
- Individual participant dataSharing planned: No
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Not yet recruitingPhase 3
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Active, not recruitingObservational study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco Landi, MD principal investigator
Catholic University of the Sacred Heart
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Red Beetroot Juice in people with Long COVID, run by Catholic University of the Sacred Heart at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue resistance (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06535165, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2024.