NCT lookup
Pull any trial record directly from ClinicalTrials.gov.
Sponsor: VA Office of Research and Development
Conditions: Long COVID, Cardiorespiratory Fitness
Interventions: 140 ml per day of Beet-It nitrate beverage (James White Drinks Ltd., Ipswich, UK), 210 ml of nitrate-depleted placebo
Countries: United States
Potential benefits of a nitrate-rich juice supplement to improve skeletal muscle function and associated physical capacity will be studied in patients with Long COVID. Consenting patients with Long-COVID will be randomized to receive Beet-It nitrate beverage group versus a nitrate-depleted placebo beverage. Both groups will receive physical therapy at the long COVID Clinic at VAPHS with therapeutic goals to improve strength, balance, inspiratory, and aerobic capabilities. Physical therapy will last for 2 weeks and include 2 or 3 sessions with a physical therapist a week depending on each individual's exercise tolerance. These sessions can take place on-site or at home (or a hybrid combination) All participants will undergo functional assessments and tissue assessments before and after the 14-day study intervention.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: * Veterans with prior COVID-19, with residual symptoms of long COVID including increased fatigability. * Inclusion limited to age 18 and over Exclusion Criteria: * Blood pressure \<110/60 mmHg, either systolic or diastolic value which may affect participant safety during assessments will be at the discretion of the study physician * Unable to hold warfarin, novel oral anticoagulants (NOACs) or aspirin for 3 days prior to muscle biopsy, or to hold thienopyridine medications for 5 days prior to muscle biopsy * Current use of organic nitrates or phosphodiesterase type 5 (PDE5) inhibitors * Orthopedic or other chronic condition which limits physical activity or functional testing assessments * End-stage disease * Dementia or other reason unable to give informed consent * Anemia (hemoglobin \<11.0 g/dL in men or hemoglobin \<10.0 g/dL in women) * Unstable psychiatric diagnosis * Clinically significant alcohol intake or substance abuse * Chronic use of oral corticosteroids or medications that affect muscle function * Use of anti-bacterial mouthwash or antacids that confound the nitrate/nitrite/NO pathway. * Suicidal ideations * Unwilling to hold Viagra-like drugs (i.e. Viagra, Cialis, Levitra, other phosphodiesterase inhibitors) * Involved in another greater than minimal risk study * Other clinically unstable medical condition as determined by the study physician
- Pittsburgh, Pennsylvania, United States