Clinical trial NCT05720013: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
CVA
Keywords: dietary nitrate
Beetroot Juice
High-Intensity Gait Training
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2023-02-09
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized repeated-measure crossover study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes in gait efficiency during steady state walking
timeFrame: Measures assessed prior to and following 2-3 hours after beetroot juice or placebo ingestion
measure: Changes in plasma levels of Nitrate and Nitrite
timeFrame: Measures assessed prior to and following 2-3 hours after beetroot juice or placebo ingestion
Secondary outcomes:
measure: Changes in peak Treadmill Speed
timeFrame: Measures assessed prior to and following 2-3 hours after beetroot juice or placebo ingestion
measure: Changes in peak oxygen consumption during maximum gait speed
timeFrame: Measures assessed prior to and following 2-3 hours after beetroot juice or placebo ingestion.
measure: Changes in peak heart rate during the graded treadmill test
timeFrame: Measures assessed prior to and following 2-3 hours after beetroot juice or placebo ingestion.
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Rehabilitation Hospital of Indiana
state: Indiana
Study officials:
References:
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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.
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