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Dietary Supplement

Nitrate Supplement for Long COVID

Phase 3
Recruiting
Led By Daniel E. Forman, MD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Veterans with prior COVID-19, with residual symptoms of long COVID including increased fatigability (i.e., RPE 10 during steady-state walking and reduced physical activity (<8 Mets/day))
Inclusion limited to age 18 and over
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks
Awards & highlights

Study Summary

This trial will study how a juice supplement can help people with Long COVID improve strength, balance, and aerobic capability with physical therapy.

Who is the study for?
This trial is for veterans over 18 who've had COVID-19 and are now experiencing long-term fatigue and reduced physical activity. They must not have low blood pressure, be able to pause certain medications before a muscle biopsy, give informed consent, and should not have conditions that limit their movement or other serious health issues.Check my eligibility
What is being tested?
The study tests if drinking Beet-It nitrate juice daily can help improve muscle function in Long COVID patients compared to a placebo drink. All participants will also receive physical therapy aimed at enhancing strength and aerobic capacity over two weeks.See study design
What are the potential side effects?
While the trial description does not specify side effects of the Beet-It beverage, potential general side effects may include changes in blood pressure or interactions with certain medications due to its nitrate content.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a veteran with long COVID, feeling very tired and less active than before.
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Fatigability
Walking Efficiency
Secondary outcome measures
Walk Test
Mitochondrial Respiration
Oxygen
+2 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Beet-It nitrate beverageActive Control1 Intervention
Participant will receive 210 ml per day of Beet-It nitrate beverage for 16 mmol of nitrate/day for 14. All participants will undergo physical therapy 2-3 times per week based on tolerance for activity and recovery needed after each session. Physical therapy will be standardized to include strength, balance, inspiratory muscle training, and aerobic training.
Group II: Nitrate-depleted placebo.Placebo Group1 Intervention
Participants will receive 210 ml of nitrate-depleted placebo for 14 days. All participants will undergo physical therapy 2-3 times per week based on tolerance for activity and recovery needed after each session. Physical therapy will be standardized to include strength, balance, inspiratory muscle training, and aerobic training.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,606 Previous Clinical Trials
3,305,965 Total Patients Enrolled
University of PittsburghOTHER
1,716 Previous Clinical Trials
16,346,414 Total Patients Enrolled
Daniel E. Forman, MDPrincipal InvestigatorVA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
1 Previous Clinical Trials
52 Total Patients Enrolled

Media Library

Beet-It Nitrate Beverage (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT05618574 — Phase 3
Cardiorespiratory Fitness Research Study Groups: Beet-It nitrate beverage, Nitrate-depleted placebo.
Cardiorespiratory Fitness Clinical Trial 2023: Beet-It Nitrate Beverage Highlights & Side Effects. Trial Name: NCT05618574 — Phase 3
Beet-It Nitrate Beverage (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05618574 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there any danger in consuming Beet-It nitrate drink?

"There is some evidence of efficacy and multiple rounds of data supporting safety, so the Beet-It nitrate beverage received a score of 3."

Answered by AI

What are the main goals of this experiment?

"The primary outcome of this study, which will be evaluated over a 2 weeks time frame is to Walking Efficiency. Secondary outcomes include Short Performance Physical Battery (SPPB) which is defined as a test of balance, gait, strength, and endurance that combines gait speed, chair stand and balance tests. SPPB scale ranges from 0 - 12. 0 indicating that the participant is unable/barely able to perform the tasks while 12 indicates they are completed all tasks optimally., Mitochondrial Respiration which is defined as Mitochondrial respiration is assessed at baseline and 2 weeks using Oroboros equipment. The capacity of nitrate"

Answered by AI

Are new participants being enrolled in this clinical trial at this time?

"According to the latest information available on clinicaltrials.gov, this particular trial is not looking for new patients at the moment. The listing was created on 1/1/2023 and last updated on 11/14/2022. There are currently 25 other trials that are actively recruiting participants."

Answered by AI

Who else is applying?

What site did they apply to?
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
~20 spots leftby Aug 2024