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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05720013
• Other study ID #: 15055
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2023
• Source: Indiana University
• Contact: George Hornby
• Phone: 317-329-2353
• Email: tghornby[@]iu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• CVA
• Stroke

Intervention

Dietary Supplement:
• Beetroot Juice supplement
The experimental arm includes orally ingesting 140 mL Beet-It Sport Nitrate 400.
• Placebo supplement
he placebo arm involves orally ingesting a 140 mL placebo solution with the dietary nitrate removed.

Locations

Country	Name	City	State
United States	Rehabilitation Hospital of Indiana	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in gait efficiency during steady state walking	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
Primary	Changes in plasma levels of Nitrate and Nitrite	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	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.	Measures assessed prior to and following 2-3 hours after beetroot juice or placebo ingestion
Secondary	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	Measures assessed prior to and following 2-3 hours after beetroot juice or placebo ingestion.
Secondary	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	Measures assessed prior to and following 2-3 hours after beetroot juice or placebo ingestion.