SARS CoV 2 InfectionNCT06217211
Eficacia Ventilatoria y Remolacha
A study testing Remolacha in people with SARS CoV 2 Infection and Muscle Disorder, run by Hospital de Mataró at 1 site in Spain.
Trial summary
The lung is the organ most affected by COVID-19. There are patients who successfully overcome the acute COVID-19 infection and their lungs return to a normal state. However, a significant number present dyspnea and fatigue as sequelae without having a pulmonary origin, but with a significant impact on functionality. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- SARS CoV 2 Infection, Muscle Disorder, Fatigue
- What is being tested?
- Remolacha
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 13 Nov 2023to 31 May 2024
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with fatigue after SARS CoV2 infection.
- Written informed consent signed by the study candidates (see Addendum 1), after receiving complete information about the objectives, techniques and possible consequences of the study.
Who cannot join
- Previous cardiovascular, oncological, neuromuscular or metabolic pathologies that could interfere with the results.
- Significant alcoholism (>80 g/day) or severe malnutrition
- Chronic treatment with drugs with potential effects on muscle structure and function
- Patient treated with nitrates
- Patients diagnosed prior to the infection with fibromyalgia or chronic fatigue.
- Patient who has a contraindication to carrying out a stress test.
- Patients allergic to beets
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Eulogio Pleguezuelos
Mataró, Barcelona, 08304
Eulogio Pleguezuelos, MD PhD, 937417700 ext. 2187, epleguezuelos@csdm.cat
About this study
Official title: Assessment of Ventilatory Efficacy in Patients With Fatigue Associated With SARS-CoV2 Infection After Ingestion of Beet Juice
The lung is the organ most affected by COVID-19. There are patients who successfully overcome the acute COVID-19 infection and their lungs return to a normal state. However, a significant number present dyspnea and fatigue as sequelae without having a pulmonary origin, but with a significant impact on functionality. In our published studies in relation to fatigue in patients with symptoms attributed to persistent COVID, the investigators have shown that there is muscle involvement, observing a decrease in mechanical efficiency. This muscle involvement causes stimulation of ventilation through the ergoreceptors, causing ineffective ventilation. This affectation can be explained by the findings obtained in the muscle biopsies that the investigators have performed, where the investigators observed a splitting of the basement membrane of the capillaries causing an alteration in the diffusion of metabolic substrates and oxygen.
The main objective of our project is to be able to observe the response in ventilatory efficiency in patients with symptoms of post-covid fatigue after ingesting beet juice.
Read the detailed description
Long COVID is a multisystem condition that comprises a set of symptoms following a SARS-CoV-2 infection. At least 65 million people around the world present symptoms associated with persistent COVID, an incidence of 10% of infected people is estimated1. The incidence is estimated at 10-30% of non-hospitalized cases, 50-70% of hospitalized cases2,3, and 10-12% of vaccinated cases4,5. Persistent COVID is associated with all ages and severity of illness in the acute phase, with the highest percentage of diagnoses between the ages of 36 and 50 years, and the majority of cases of persistent COVID are found in non-hospitalized patients with a mild acute illness6, as this population represents the majority of overall COVID-19 cases. The most prevalent symptoms in persistent COVID are fatigue, dyspnea and weakness7.
In our first published study the investigators observed that patients with fatigue after SARS CoA2 infection behaved very similarly to COPD patients, observing a decrease in mechanical efficiency (ME) at the first threshold, second threshold and at maximum consumption. of oxygen during an incremental test8. (Figure 1).
Mechanical efficiency (ME) refers to the ability of an individual to transform oxygen consumption into effective work. In other words, poorer efficiency will increase the percentage of maximum oxygen uptake (VO2max) needed to sustain a given mechanical work. A decrease in ME, indicating that more energy is expended in a given work output, could represent an increased energy cost of respiration during exercise, an altered efficiency in ATP production (ATP produced per O2 consumed), or a higher ATP cost of contraction (ATP consumed by work production)9. Patients with a decreased ME would decrease their performance and, therefore, could be limited in terms of physical activity9.
In our second study, the investigators observed that patients recovered from SARS-CoV-2 but with symptoms of fatigue presented significant muscle dysfunction compared to healthy women with similar characteristics. These findings were corroborated by detecting an increase in VO2sc and a deterioration in ME and ventilatory efficiency during the constant load test10. These results guide us towards a problem of oxygen diffusion in the muscle cell that the investigators are confirming with the findings currently obtained in quadriceps muscle biopsies. The hypothesis of causing an increase in the dilation of muscle capillaries to improve oxygen diffusion made us think about the vasodilator and ergogenic effects of beets.
Beet juice (BRJ) has become increasingly popular among athletes looking to improve sports performance. BRJ contains high concentrations of nitrate, which can be converted to nitric oxide (NO) after consumption. NO has several functions in the human body, including a vasodilatory effect, which reduces blood pressure and increases the delivery of oxygen and nutrients to various organs. BRJ consumption also has an impact on oxygen delivery to skeletal muscles, muscle efficiency, tolerance and endurance and can therefore have a positive impact on sports performance12.
Once ingested, NO3- is reduced to nitrite (NO2-) by anaerobic bacteria in the oral cavity through the action of nitrate reductase enzymes13 and then to nitric oxide (NO) in the stomach14. This physiological mechanism depends on the entero-salivary circulation of inorganic nitrate without involving the activity of NOS. Once in the stomach (at an acidic pH), nitrite is instantly decomposed to become NO and other nitrogen oxides that perform crucial physiological functions. The remaining nitrate and nitrite are absorbed from the intestine into the circulation, which can be converted to bioactive NO in tissues and blood under conditions of physiological hypoxia14. NO induces several physiological mechanisms that influence O2 utilization during contraction of the intestine. skeletal muscle. The physiological mechanisms for NO2- reduction are facilitated by hypoxic conditions, therefore NO is produced in those parts of the muscle that consume or need more O2. This mechanism would allow local blood flow to adapt to the O2 requirement, providing an adequate homogeneous distribution within the skeletal muscle. This physiological response could be positive in terms of muscle function, although it would not explain the reduction in O2 expenditure during exercise15. Another probable mechanism is related to NO2- and NO as regulators of cellular O2 utilization15.
- Conditions
- SARS CoV 2 Infection, Muscle Disorder, Fatigue
- Being tested
- Remolacha
- Medical subject headings
- COVID-19, Muscular Diseases, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemolachaDietary supplement
BJ or PL will be administered 3 h before the start of the NO2- evaluation test since the peak in blood occurs 2-3 h after ingesting NO3-. Both drinks (BJ and PL) will be provided in an unlabeled 140ml maroon red plastic bottle. Participants will receive a randomly assigned bottle. containing 140 ml (~ 12.8 mmol, ~ 808 mg NO3-) of BJ Beet-It-Pro Elite Shot concentrate (Beet IT; James White Drinks Ltd., Ipswich, United Kingdom) or PL.
| Study group | Role | What they receive |
|---|---|---|
| Remolacha | Experimental | beet juice Receives: Dietary Supplement: Remolacha |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Remolacha |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2max
maximum oxygen consumption
Measured: 1 determination per week for 3 weeks
CMT
Maximum Tolerated Load
Measured: 1 determination per week for 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start13 Nov 2023
- Primary completion31 Jan 2024 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS CoV 2 InfectionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Mataró
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eulogio Pleguezuelos, Hospital de Mataró
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06217211
- Sponsor's protocol ID
- CEIM15/23
- Status last verified
- Jan 2024
- First submitted
- 22 Dec 2023
- Last updated
- 22 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Ventilatory Efficacy in Patients With Fatigue Associated With SARS-CoV2 Infection After Ingestion of Beet Juice
- ClinicalTrials.gov ID
- NCT06217211
- Acronym / sponsor ID
- CEIM15/23
- Conditions
- SARS CoV 2 Infection, Muscle Disorder, Fatigue
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hospital de MataróUniversity, hospital or other
- Study start
- 13 Nov 2023 (actual)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 22 Jan 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.
The lung is the organ most affected by COVID-19. There are patients who successfully overcome the acute COVID-19 infection and their lungs return to a normal state. However, a significant number present dyspnea and fatigue as sequelae without having a pulmonary origin, but with a significant impact on functionality. In our published studies in relation to fatigue in patients with symptoms attributed to persistent COVID, the investigators have shown that there is muscle involvement, observing a decrease in mechanical efficiency. This muscle involvement causes stimulation of ventilation through the ergoreceptors, causing ineffective ventilation. This affectation can be explained by the findings obtained in the muscle biopsies that the investigators have performed, where the investigators observed a splitting of the basement membrane of the capillaries causing an alteration in the diffusion of metabolic substrates and oxygen.
The main objective of our project is to be able to observe the response in ventilatory efficiency in patients with symptoms of post-covid fatigue after ingesting beet juice.
Detailed description
Long COVID is a multisystem condition that comprises a set of symptoms following a SARS-CoV-2 infection. At least 65 million people around the world present symptoms associated with persistent COVID, an incidence of 10% of infected people is estimated1. The incidence is estimated at 10-30% of non-hospitalized cases, 50-70% of hospitalized cases2,3, and 10-12% of vaccinated cases4,5. Persistent COVID is associated with all ages and severity of illness in the acute phase, with the highest percentage of diagnoses between the ages of 36 and 50 years, and the majority of cases of persistent COVID are found in non-hospitalized patients with a mild acute illness6, as this population represents the majority of overall COVID-19 cases. The most prevalent symptoms in persistent COVID are fatigue, dyspnea and weakness7.
In our first published study the investigators observed that patients with fatigue after SARS CoA2 infection behaved very similarly to COPD patients, observing a decrease in mechanical efficiency (ME) at the first threshold, second threshold and at maximum consumption. of oxygen during an incremental test8. (Figure 1).
Mechanical efficiency (ME) refers to the ability of an individual to transform oxygen consumption into effective work. In other words, poorer efficiency will increase the percentage of maximum oxygen uptake (VO2max) needed to sustain a given mechanical work. A decrease in ME, indicating that more energy is expended in a given work output, could represent an increased energy cost of respiration during exercise, an altered efficiency in ATP production (ATP produced per O2 consumed), or a higher ATP cost of contraction (ATP consumed by work production)9. Patients with a decreased ME would decrease their performance and, therefore, could be limited in terms of physical activity9.
In our second study, the investigators observed that patients recovered from SARS-CoV-2 but with symptoms of fatigue presented significant muscle dysfunction compared to healthy women with similar characteristics. These findings were corroborated by detecting an increase in VO2sc and a deterioration in ME and ventilatory efficiency during the constant load test10. These results guide us towards a problem of oxygen diffusion in the muscle cell that the investigators are confirming with the findings currently obtained in quadriceps muscle biopsies. The hypothesis of causing an increase in the dilation of muscle capillaries to improve oxygen diffusion made us think about the vasodilator and ergogenic effects of beets.
Beet juice (BRJ) has become increasingly popular among athletes looking to improve sports performance. BRJ contains high concentrations of nitrate, which can be converted to nitric oxide (NO) after consumption. NO has several functions in the human body, including a vasodilatory effect, which reduces blood pressure and increases the delivery of oxygen and nutrients to various organs. BRJ consumption also has an impact on oxygen delivery to skeletal muscles, muscle efficiency, tolerance and endurance and can therefore have a positive impact on sports performance12.
Once ingested, NO3- is reduced to nitrite (NO2-) by anaerobic bacteria in the oral cavity through the action of nitrate reductase enzymes13 and then to nitric oxide (NO) in the stomach14. This physiological mechanism depends on the entero-salivary circulation of inorganic nitrate without involving the activity of NOS. Once in the stomach (at an acidic pH), nitrite is instantly decomposed to become NO and other nitrogen oxides that perform crucial physiological functions. The remaining nitrate and nitrite are absorbed from the intestine into the circulation, which can be converted to bioactive NO in tissues and blood under conditions of physiological hypoxia14. NO induces several physiological mechanisms that influence O2 utilization during contraction of the intestine. skeletal muscle. The physiological mechanisms for NO2- reduction are facilitated by hypoxic conditions, therefore NO is produced in those parts of the muscle that consume or need more O2. This mechanism would allow local blood flow to adapt to the O2 requirement, providing an adequate homogeneous distribution within the skeletal muscle. This physiological response could be positive in terms of muscle function, although it would not explain the reduction in O2 expenditure during exercise15. Another probable mechanism is related to NO2- and NO as regulators of cellular O2 utilization15.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remolacha | Experimental | Dietary Supplement: Remolachabeet juice |
| Placebo | Placebo comparator | Dietary Supplement: Remolacha |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with fatigue after SARS CoV2 infection.
- Written informed consent signed by the study candidates (see Addendum 1), after receiving complete information about the objectives, techniques and possible consequences of the study.
Key exclusion criteria (7 listed)
- Previous cardiovascular, oncological, neuromuscular or metabolic pathologies that could interfere with the results.
- Significant alcoholism (>80 g/day) or severe malnutrition
- Chronic treatment with drugs with potential effects on muscle structure and function
- Patient treated with nitrates
- Patients diagnosed prior to the infection with fibromyalgia or chronic fatigue.
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 |
|---|---|---|
| RemolachaBJ or PL will be administered 3 h before the start of the NO2- evaluation test since the peak in blood occurs 2-3 h after ingesting NO3-. Both drinks (BJ and PL) will be provided in an unlabeled 140ml maroon red plastic bottle. Participants will receive a randomly assigned bottle. containing 140 ml (~ 12.8 mmol, ~ 808 mg NO3-) of BJ Beet-It-Pro Elite Shot concentrate (Beet IT; James White Drinks Ltd., Ipswich, United Kingdom) or PL. | Dietary supplement | Placebo, Remolacha |
Primary outcome
VO2max
Time frame: 1 determination per week for 3 weeks
maximum oxygen consumption
CMT
Time frame: 1 determination per week for 3 weeks
Maximum Tolerated Load
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remolacha in people with SARS CoV 2 Infection and Muscle Disorder, run by Hospital de Mataró at 1 site in Spain.
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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 22 Jan 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eulogio Pleguezuelos, MD PhD (937417700 ext. 2187, epleguezuelos@csdm.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VO2max (time frame: 1 determination per week for 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jan 2024.