NCT05720013

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

August 22, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 9, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

May 22, 2024

Status Verified

May 1, 2024

Enrollment Period

11 months

First QC Date

August 22, 2022

Last Update Submit

May 21, 2024

Conditions

StrokeCVA

Keywords

dietary nitrateBeetroot JuiceHigh-Intensity Gait Training

Outcome Measures

Primary Outcomes (2)

  • Changes in gait efficiency during steady state walking

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

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

  • Changes in plasma levels of Nitrate and Nitrite

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

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

Secondary Outcomes (3)

  • Changes in peak Treadmill Speed

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

  • Changes in peak oxygen consumption during maximum gait speed

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

  • Changes in peak heart rate during the graded treadmill test

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

Study Arms (2)

Beetroot Juice Supplement

EXPERIMENTAL

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

Dietary Supplement: Beetroot Juice supplement

Placebo Supplement

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo supplement

Interventions

Beetroot Juice supplementDIETARY_SUPPLEMENT

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

Beetroot Juice Supplement
Placebo supplementDIETARY_SUPPLEMENT

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

Also known as: Placebo Beetroot Juice supplement
Placebo Supplement

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rehabilitation Hospital of Indiana

Indianapolis, Indiana, 46254, United States

Location

Related Publications (7)

  • 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.

    PMID: 32294579BACKGROUND

  • 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.

    PMID: 28916479BACKGROUND

  • 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.

    PMID: 20937740BACKGROUND

  • 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.

    PMID: 27632078BACKGROUND

  • 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.

    PMID: 19915529BACKGROUND

  • 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.

    PMID: 18167491BACKGROUND

  • 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.

    PMID: 30001275BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Randomized repeated-measure crossover study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 22, 2022

First Posted

February 9, 2023

Study Start

February 1, 2023

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

May 22, 2024

Record last verified: 2024-05

Locations

US(1)