NCT06217211

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 13, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 22, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 22, 2024

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

January 22, 2024

Status Verified

January 1, 2024

Enrollment Period

3 months

First QC Date

December 22, 2023

Last Update Submit

January 11, 2024

Conditions

SARS CoV 2 InfectionMuscle DisorderFatigue

Outcome Measures

Primary Outcomes (2)

  • VO2max

    maximum oxygen consumption

    1 determination per week for 3 weeks

  • CMT

    Maximum Tolerated Load

    1 determination per week for 3 weeks

Study Arms (2)

Remolacha

EXPERIMENTAL

beet juice

Dietary Supplement: Remolacha

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Remolacha

Interventions

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.

PlaceboRemolacha

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eulogio Pleguezuelos

Mataró, Barcelona, 08304, Spain

RECRUITING

MeSH Terms

Conditions

COVID-19Muscular DiseasesFatigue

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Eulogio Pleguezuelos, MD PhD

CONTACT

937417700epleguezuelos@csdm.cat

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

December 22, 2023

First Posted

January 22, 2024

Study Start

November 13, 2023

Primary Completion

January 31, 2024

Study Completion

May 31, 2024

Last Updated

January 22, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)