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Completed

NCT Number: NCT05720013

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

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.

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Key information

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rehabilitation Hospital of Indiana

Indianapolis, Indiana, 46254, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Beetroot Juice supplement

Dietary Supplement

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

Placebo supplement

Dietary Supplement

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

Other names: Placebo Beetroot Juice supplement

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 9, 2023
Registry last updated
May 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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