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StrokeNCT05720013

Acute Effects of Beetroot Juice on Locomotor Economy and Capacity in Chronic Stroke

A study testing Beetroot Juice supplement in people with Stroke and CVA, run by Indiana University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to investigate if a beetroot juice supplement can improve oxygen capacity during walking tasks at a submaximal and maximal effort in people greater than 6 months following stroke. Read more about this study

Who is it for?
Ages 18 to 89 years
Conditions the study is for
Stroke, CVA
What is being tested?
Beetroot Juice supplement
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
22 participants
Where
1 siteUnited States
Study dates
1 Feb 2023to 31 Dec 2023
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 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • adults aged 18-89 years
  • diagnosis of chronic hemiparesis following unilateral stroke (greater than six months)
  • ability to ambulate at least 0.3 m/s, with or without using an assistive device or bracing below the knee
  • ability to read and understand English
  • follow three-step commands

Who cannot join

  • presence of cerebellar deficits
  • any other neurological or orthopedic deficits that would limit walking ability
  • smoking
  • cannot receive physical therapy for gait-related impairments
  • uncontrolled metabolic, respiratory, and cardiovascular disease

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Rehabilitation Hospital of Indiana

    Indianapolis, Indiana, 46254

Other trials in United States

About this study

The purpose of this study is to investigate if a beetroot juice supplement can improve oxygen capacity during walking tasks at a submaximal and maximal effort in people greater than 6 months following stroke.

Read the detailed description

During this study, participants will perform baseline measurements such as walking and balance tests. During baseline testing, participants will be asked to perform a maximal exertion test while walking on a treadmill to determine the speed for a submaximal walking test. One week after baseline testing, the participant will have an intervention session where they drink either a beetroot juice supplement or a placebo. The placebo will taste similar to the beetroot juice and participants may not be able to tell the difference between the two different supplements. After a week, the participant will return to the lab and drink the other supplement. For example, if the participant drank the beetroot juice in the first session, then they will drink the placebo in the second session. During each intervention session, the participant will be asked to perform two treadmill tests, one with submaximal effort and one with maximal effort. After the walking tests, they will drink either the beetroot juice or placebo and have their blood drawn. They will wait at the hospital for 2-3 hours and have their blood drawn again. The participants will then complete the two treadmill tests again. The two intervention sessions will last about 4-6 hours for each session. Participation in the study will last 4-6 weeks including screening and baseline testing.

Conditions
Stroke, CVA
Being tested
Beetroot Juice supplement, Placebo supplement
Keywords
dietary nitrate, Beetroot Juice, High-Intensity Gait Training
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Beetroot Juice supplementDietary supplement

    The experimental arm includes orally ingesting 140 mL Beet-It Sport Nitrate 400.

  • Placebo supplementDietary supplement

    Also called Placebo Beetroot Juice supplement

    he placebo arm involves orally ingesting a 140 mL placebo solution with the dietary nitrate removed.

Study groups in NCT05720013
Study groupRoleWhat they receive
Beetroot Juice SupplementExperimental140 mL of beetroot juice supplement will be ingested orally (Beet-It Nitrate 400, James White Co).
Receives: Dietary Supplement: Beetroot Juice supplement
Placebo SupplementPlacebo comparator140 mL of placebo supplement will be ingested orally (Beet-It Nitrate 400, James White Co).
Receives: Dietary Supplement: Placebo supplement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in gait efficiency during steady state walking

    Oxygen Consumption during steady state walking prior to and following placebo or beetroot juice ingestion

    Measured: Measures assessed prior to and following 2-3 hours after beetroot juice or placebo ingestion

  2. Changes in plasma levels of Nitrate and Nitrite

    Blood samples taken prior and following ingestion of either the beetroot juice or placebo supplements.

    Measured: Measures assessed prior to and following 2-3 hours after beetroot juice or placebo ingestion

Secondary outcomes (3)

  1. Changes in peak Treadmill Speed

    Fastest speed achieved for one minute on the treadmill during the graded treadmill test performed prior to and following placebo or beetroot juice ingestion.

    Measured: Measures assessed prior to and following 2-3 hours after beetroot juice or placebo ingestion

  2. Changes in peak oxygen consumption during maximum gait speed

    Oxygen Consumption during maximal exertion walking during the graded treadmill test prior to and following placebo or beetroot juice ingestion

    Measured: Measures assessed prior to and following 2-3 hours after beetroot juice or placebo ingestion.

  3. Changes in peak heart rate during the graded treadmill test

    Peak heart rate during maximal exertion walking on the graded treadmill test prior to and following placebo or beetroot juice ingestion

    Measured: Measures assessed prior to and following 2-3 hours after beetroot juice or placebo ingestion.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2023
  2. Study start1 Feb 2023
  3. Primary completion31 Dec 2023
  4. Study completion31 Dec 2023

Resources

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
Crossover
Model description
Randomized repeated-measure crossover study
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05720013
Sponsor's protocol ID
15055
Status last verified
May 2024
First submitted
22 Aug 2022
Last updated
22 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Carter SJ, Gruber AH, Raglin JS, Baranauskas MN, Coggan AR. Potential health effects of dietary nitrate supplementation in aging and chronic degenerative disease. Med Hypotheses. 2020 Aug;141:109732. doi: 10.1016/j.mehy.2020.109732. Epub 2020 Apr 9.

    PubMed 32294579

  • Coggan AR, Broadstreet SR, Mahmood K, Mikhalkova D, Madigan M, Bole I, Park S, Leibowitz JL, Kadkhodayan A, Thomas DP, Thies D, Peterson LR. Dietary Nitrate Increases VO2peak and Performance but Does Not Alter Ventilation or Efficiency in Patients With Heart Failure With Reduced Ejection Fraction. J Card Fail. 2018 Feb;24(2):65-73. doi: 10.1016/j.cardfail.2017.09.004. Epub 2017 Sep 12.

    PubMed 28916479

  • Lundberg JO, Carlstrom M, Larsen FJ, Weitzberg E. Roles of dietary inorganic nitrate in cardiovascular health and disease. Cardiovasc Res. 2011 Feb 15;89(3):525-32. doi: 10.1093/cvr/cvq325. Epub 2010 Oct 11.

    PubMed 20937740

  • Leddy AL, Connolly M, Holleran CL, Hennessy PW, Woodward J, Arena RA, Roth EJ, Hornby TG. Alterations in Aerobic Exercise Performance and Gait Economy Following High-Intensity Dynamic Stepping Training in Persons With Subacute Stroke. J Neurol Phys Ther. 2016 Oct;40(4):239-48. doi: 10.1097/NPT.0000000000000147.

    PubMed 27632078

  • Lundberg JO, Gladwin MT, Ahluwalia A, Benjamin N, Bryan NS, Butler A, Cabrales P, Fago A, Feelisch M, Ford PC, Freeman BA, Frenneaux M, Friedman J, Kelm M, Kevil CG, Kim-Shapiro DB, Kozlov AV, Lancaster JR Jr, Lefer DJ, McColl K, McCurry K, Patel RP, Petersson J, Rassaf T, Reutov VP, Richter-Addo GB, Schechter A, Shiva S, Tsuchiya K, van Faassen EE, Webb AJ, Zuckerbraun BS, Zweier JL, Weitzberg E. Nitrate and nitrite in biology, nutrition and therapeutics. Nat Chem Biol. 2009 Dec;5(12):865-9. doi: 10.1038/nchembio.260.

    PubMed 19915529

  • Lundberg JO, Weitzberg E, Gladwin MT. The nitrate-nitrite-nitric oxide pathway in physiology and therapeutics. Nat Rev Drug Discov. 2008 Feb;7(2):156-67. doi: 10.1038/nrd2466.

    PubMed 18167491

  • Coggan AR, Peterson LR. Dietary Nitrate Enhances the Contractile Properties of Human Skeletal Muscle. Exerc Sport Sci Rev. 2018 Oct;46(4):254-261. doi: 10.1249/JES.0000000000000167.

    PubMed 30001275

Questions about this trial

What is this clinical trial studying?

A study testing Beetroot Juice supplement in people with Stroke and CVA, run by Indiana University at 1 site in United States.

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 5 inclusion and 5 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 22 May 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 United States. 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?

Changes in gait efficiency during steady state walking (time frame: Measures assessed prior to and following 2-3 hours after beetroot juice or placebo ingestion). 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?

On the ClinicalTrials.gov record for NCT05720013, which also lists 7 linked publications.

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 May 2024.

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Clinical Trial NCT05720013 | AzTrials