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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Beetroot Juice Supplement | Experimental | 140 mL of beetroot juice supplement will be ingested orally (Beet-It Nitrate 400, James White Co). |
|
| Placebo Supplement | Placebo Comparator | 140 mL of placebo supplement will be ingested orally (Beet-It Nitrate 400, James White Co). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beetroot Juice supplement | Dietary Supplement | The experimental arm includes orally ingesting 140 mL Beet-It Sport Nitrate 400. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Changes in peak oxygen consumption during maximum gait speed |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rehabilitation Hospital of Indiana | Indianapolis | Indiana | 46254 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32294579 | Background | 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. | |
| 28916479 | Background | 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. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Randomized repeated-measure crossover study
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| Placebo supplement | Dietary Supplement | he placebo arm involves orally ingesting a 140 mL placebo solution with the dietary nitrate removed. |
|
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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 | 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. |
| 20937740 | Background | 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. |
| 27632078 | Background | 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. |
| 19915529 | Background | 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. |
| 18167491 | Background | 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. |
| 30001275 | Background | 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. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |