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

NCT ID: NCT05720013

Last Updated: 2024-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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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

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Stroke CVA

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized repeated-measure crossover study
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Beetroot Juice Supplement

140 mL of beetroot juice supplement will be ingested orally (Beet-It Nitrate 400, James White Co).

Group Type EXPERIMENTAL

Beetroot Juice supplement

Intervention Type DIETARY_SUPPLEMENT

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

Placebo Supplement

140 mL of placebo supplement will be ingested orally (Beet-It Nitrate 400, James White Co).

Group Type PLACEBO_COMPARATOR

Placebo supplement

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Beetroot Juice supplement

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

Intervention Type DIETARY_SUPPLEMENT

Placebo supplement

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Placebo Beetroot Juice supplement

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indiana University

OTHER

Sponsor Role lead

Responsible Party

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George Hornby

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Rehabilitation Hospital of Indiana

Indianapolis, Indiana, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 32294579 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28916479 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20937740 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27632078 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19915529 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18167491 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30001275 (View on PubMed)

Other Identifiers

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15055

Identifier Type: -

Identifier Source: org_study_id

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