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

Not Applicable

Completed

• Conditions: CVA; Stroke
• Interventions: Dietary Supplement: Placebo supplement; Dietary Supplement: Beetroot Juice supplement

• Registration Number: NCT05720013
• Lead Sponsor: Indiana University

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.

Study Timeline

• Study First Submitted: 2022-08-22
• Study First Submitted QC: 2023-01-30
• Study Start: 2023-02-01
• Study First Posted: 2023-02-09
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-21
• Last Update Posted: 2024-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo Supplement	Placebo supplement	140 mL of placebo supplement will be ingested orally (Beet-It Nitrate 400, James White Co).
Beetroot Juice Supplement	Beetroot Juice supplement	140 mL of beetroot juice supplement will be ingested orally (Beet-It Nitrate 400, James White Co).

Primary Outcome Measures

Name	Time	Method
Changes in plasma levels of Nitrate and Nitrite	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.
Changes in gait efficiency during steady state walking	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

Secondary Outcome Measures

Name	Time	Method
Changes in peak Treadmill Speed	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.
Changes in peak oxygen consumption during maximum gait speed	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
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.	Peak heart rate during maximal exertion walking on the graded treadmill test prior to and following placebo or beetroot juice ingestion

Trial Locations

Locations (1)

Rehabilitation Hospital of Indiana; 🇺🇸 Indianapolis, Indiana, United States