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

Primary Purpose

Stroke, CVA

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Beetroot Juice supplement
Placebo supplement
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring dietary nitrate, Beetroot Juice, High-Intensity Gait Training

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rehabilitation Hospital of IndianaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Beetroot Juice Supplement

Placebo Supplement

Arm Description

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

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

Outcomes

Primary Outcome Measures

Changes in gait efficiency during steady state walking
Oxygen Consumption during steady state walking prior to and following placebo or beetroot juice ingestion
Changes in plasma levels of Nitrate and Nitrite
Blood samples taken prior and following ingestion of either the beetroot juice or placebo supplements.

Secondary Outcome Measures

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.
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
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

Full Information

First Posted
August 22, 2022
Last Updated
July 31, 2023
Sponsor
Indiana University
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1. Study Identification

Unique Protocol Identification Number
NCT05720013
Brief Title
Acute Effects of Beetroot Juice on Locomotor Economy and Capacity in Chronic Stroke
Official Title
Acute Effects of Beetroot Juice on Locomotor Economy and Capacity in Chronic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, CVA
Keywords
dietary nitrate, Beetroot Juice, High-Intensity Gait Training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized repeated-measure crossover study
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Beetroot Juice Supplement
Arm Type
Experimental
Arm Description
140 mL of beetroot juice supplement will be ingested orally (Beet-It Nitrate 400, James White Co).
Arm Title
Placebo Supplement
Arm Type
Placebo Comparator
Arm Description
140 mL of placebo supplement will be ingested orally (Beet-It Nitrate 400, James White Co).
Intervention Type
Dietary Supplement
Intervention Name(s)
Beetroot Juice supplement
Intervention Description
The experimental arm includes orally ingesting 140 mL Beet-It Sport Nitrate 400.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo supplement
Other Intervention Name(s)
Placebo Beetroot Juice supplement
Intervention Description
he placebo arm involves orally ingesting a 140 mL placebo solution with the dietary nitrate removed.
Primary Outcome Measure Information:
Title
Changes in gait efficiency during steady state walking
Description
Oxygen Consumption during steady state walking prior to and following placebo or beetroot juice ingestion
Time Frame
Measures assessed prior to and following 2-3 hours after beetroot juice or placebo ingestion
Title
Changes in plasma levels of Nitrate and Nitrite
Description
Blood samples taken prior and following ingestion of either the beetroot juice or placebo supplements.
Time Frame
Measures assessed prior to and following 2-3 hours after beetroot juice or placebo ingestion
Secondary Outcome Measure Information:
Title
Changes in peak Treadmill Speed
Description
Fastest speed achieved for one minute on the treadmill during the graded treadmill test performed prior to and following placebo or beetroot juice ingestion.
Time Frame
Measures assessed prior to and following 2-3 hours after beetroot juice or placebo ingestion
Title
Changes in peak oxygen consumption during maximum gait speed
Description
Oxygen Consumption during maximal exertion walking during the graded treadmill test prior to and following placebo or beetroot juice ingestion
Time Frame
Measures assessed prior to and following 2-3 hours after beetroot juice or placebo ingestion.
Title
Changes in peak heart rate during the graded treadmill test
Description
Peak heart rate during maximal exertion walking on the graded treadmill test prior to and following placebo or beetroot juice ingestion
Time Frame
Measures assessed prior to and following 2-3 hours after beetroot juice or placebo ingestion.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
George Hornby
Phone
317-329-2353
Email
tghornby@iu.edu
Facility Information:
Facility Name
Rehabilitation Hospital of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46254
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
George Hornby
Phone
317-329-2353
Email
tghornby@iu.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32294579
Citation
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.
Results Reference
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PubMed Identifier
28916479
Citation
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.
Results Reference
background
PubMed Identifier
20937740
Citation
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.
Results Reference
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PubMed Identifier
27632078
Citation
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.
Results Reference
background
PubMed Identifier
19915529
Citation
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.
Results Reference
background
PubMed Identifier
18167491
Citation
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.
Results Reference
background
PubMed Identifier
30001275
Citation
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.
Results Reference
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Acute Effects of Beetroot Juice on Locomotor Economy and Capacity in Chronic Stroke

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