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

May 21, 2024 updated by: George Hornby, Indiana University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46254
        • Rehabilitation Hospital of Indiana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Beetroot Juice Supplement
140 mL of beetroot juice supplement will be ingested orally (Beet-It Nitrate 400, James White Co).
Dietary supplement: Beetroot Juice supplement
The experimental arm includes orally ingesting 140 mL Beet-It Sport Nitrate 400.
Placebo Comparator: Placebo Supplement
140 mL of placebo supplement will be ingested orally (Beet-It Nitrate 400, James White Co).
Dietary supplement: Placebo supplement
he placebo arm involves orally ingesting a 140 mL placebo solution with the dietary nitrate removed.
Other Names:
  • Placebo Beetroot Juice supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: Measures assessed prior to and following 2-3 hours after beetroot juice or placebo ingestion
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in peak Treadmill Speed
Time Frame: Measures assessed prior to and following 2-3 hours after beetroot juice or placebo ingestion
Fastest speed achieved for one minute on the treadmill during the graded treadmill test performed 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 peak oxygen consumption during maximum gait speed
Time Frame: Measures assessed prior to and following 2-3 hours after beetroot juice or placebo ingestion.
Oxygen Consumption during maximal exertion walking during the graded treadmill test 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 peak heart rate during the graded treadmill test
Time Frame: Measures assessed prior to and following 2-3 hours after beetroot juice or placebo ingestion.
Peak heart rate during maximal exertion walking on the graded treadmill test prior to and following placebo or beetroot juice ingestion
Measures assessed prior to and following 2-3 hours after beetroot juice or placebo ingestion.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

August 22, 2022

First Submitted That Met QC Criteria

January 30, 2023

First Posted (Actual)

February 9, 2023

Study Record Updates

Last Update Posted (Actual)

May 22, 2024

Last Update Submitted That Met QC Criteria

May 21, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15055

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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