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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06043089
Other study ID # AWF_MSIT
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 23, 2023
Est. completion date October 16, 2023

Study information

Verified date January 2024
Source University School of Physical Education, Krakow, Poland
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Several previous studies observed a positive effect of beetroot supplementation on sports performance in athletes, mainly in endurance performance. However, less attention has been paid to its effects on short-duration performance, especially in youth athletes. Moreover, only a few previous investigations performed biochemical analyses, including pro-oxidant balance assessments. It is especially important because chronic nitrate intake might directly cause the production of reactive nitrogen species and reactive oxygen species in other subcellular compartments, leading to more oxidative stress. Additionally, no previous study verified the impact of beetroot intake on sleep.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date October 16, 2023
Est. primary completion date October 16, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 14 Years to 23 Years
Eligibility Inclusion Criteria: - male - good general health assessed by physician - highly trained - written consent to participate Exclusion Criteria: - medication or dietary supplements used within the previous month, which could potentially impact the study outcomes - history of sleep nor neurological disorders - chronic use (6 months) of any antibacterial mouthwash products.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Beetroot juice supplementation or placebo
Athletes received 7 days of beetroot juice supplementation with nitrate supplementation (2 × 70 mL of beetroot juice ~12.9 mmol NO3-; Beet It, James White Drinks, Ipswich, UK) or placebo (2 × 70 mL of water with beetroot powder with negligible nitrate content).

Locations

Country Name City State
Poland University School of Physical Education in Cracow Kraków

Sponsors (2)

Lead Sponsor Collaborator
University School of Physical Education, Krakow, Poland University of Bergen

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Performance test yo-yo intermittent recovery test level 1 7 days after treatment
Primary Changes in nitrates Blood plasma will be obtained to measure nitrate concentration 1) baseline - 2) 7th day of treatment - before the supplementation, 3) 7th day of treatment - before the performance test, 4) 7th day of treatment - immediately after the performance test
Primary Changes in nitrites Blood plasma will be obtained to measure nitrite concentration 1) baseline - 2) 7th day of treatment - before the supplementation, 3) 7th day of treatment - before the performance test, 4) 7th day of treatment - immediately after the performance test
Primary Changes in prooxidant status Blood plasma will be obtained to measure total oxidative status 1) baseline - 2) 7th day of treatment - before the supplementation, 3) 7th day of treatment - before the performance test, 4) 7th day of treatment - immediately after the performance test
Primary Changes in antioxidant status Blood plasma will be obtained to measure total antioxidant capacity 1) baseline - 2) 7th day of treatment - before the supplementation, 3) 7th day of treatment - before the performance test, 4) 7th day of treatment - immediately after the performance test
Primary Changes in oxidative stress index The oxidative stress index will be calculated as the ratio of plasma prooxidant to antioxidant status 1) baseline - 2) 7th day of treatment - before the supplementation, 3) 7th day of treatment - before the performance test, 4) 7th day of treatment - immediately after the performance test
Primary Changes in nitrooxidative stress markers Blood plasma will be obtained to measure 3-nitrotyrosine concentration 1) baseline - 2) 7th day of treatment - before the supplementation, 3) 7th day of treatment - before the performance test, 4) 7th day of treatment - immediately after the performance test
Primary Changes in protein oxidation Blood plasma will be obtained to measure advanced protein oxidation products concentration 1) baseline - 2) 7th day of treatment - before the supplementation, 3) 7th day of treatment - before the performance test, 4) 7th day of treatment - immediately after the performance test
Primary Changes in nucleic acid oxidation Blood plasma will be obtained to measure ox-8-hydroxy-2'-deoxyguanosine (8-OHdG) concentration 1) baseline - 2) 7th day of treatment - before the supplementation, 3) 7th day of treatment - before the performance test, 4) 7th day of treatment - immediately after the performance test
Primary Changes in lipids oxidation Blood plasma will be obtained to measure thiobarbituric acid reactive substances concentration 1) baseline - 2) 7th day of treatment - before the supplementation, 3) 7th day of treatment - before the performance test, 4) 7th day of treatment - immediately after the performance test
Primary Changes in exercise-induced metabolic acidosis Arterialized blood will be obtained to measure lactate concentration 1) Before the performance test 2) 3 minutes after the performance test 3) 10 minutes after the performance test 4) 20 minutes after the performance test
Primary Objective Sleep - Time in bed Total time spent in bed during the night assessed by sleep radar nights 1 - 7 during treatment
Primary Objective Sleep - Sleep-onset latency The time it takes from when the athlete intends to go to sleep and actually starts to sleep assessed by sleep radar nights 1 - 7 during treatment
Primary Objective Sleep - Total sleep time Total sleep time obtained from sleep onset to time at wake-up assessed by sleep radar nights 1 - 7 during treatment
Primary Objective Sleep - Light sleep Total amount of time in light sleep assessed by sleep radar nights 1 - 7 during treatment
Primary Objective Sleep - Deep sleep Total amount of time in deep sleep assessed by sleep radar nights 1 - 7 during treatment
Primary Objective Sleep - REM sleep Total amount of time in REM sleep assessed by sleep radar nights 1 - 7 during treatment
Primary Objective Sleep - Sleep efficiency The percentage of total sleep time to lights off and leaving bed assessed by sleep radar nights 1 - 7 during treatment
Secondary Countermovement jump height 7 days after treatment
Secondary Ball speed velocity 7 days after treatment
Secondary Sprint test (0-20m) 7 days after treatment
Secondary Agility T-test 7 days after treatment
Secondary Maximal isometric handgrip strength 7 days after treatment
Secondary Flanker task 7 days after treatment
Secondary Changes in muscle damage markers Blood serum will be obtained to measure myoglobin concentration 1) baseline - 2) 7th day of treatment - before the supplementation, 3) 7th day of treatment - before the performance test, 4) 7th day of treatment - immediately after the performance test
Secondary Changes in muscle enzymes activity Blood serum will be obtained to measure creatine kinase activity 1) baseline - 2) 7th day of treatment - before the supplementation, 3) 7th day of treatment - before the performance test, 4) 7th day of treatment - immediately after the performance test
Secondary Changes in inflammation markers Blood serum will be obtained to measure C-reactive protein concentration 1) baseline - 2) 7th day of treatment - before the supplementation, 3) 7th day of treatment - before the performance test, 4) 7th day of treatment - immediately after the performance test
Secondary Changes in blood count Whole blood will be obtained to measure leukocyte count 1) baseline - 2) 7th day of treatment - before the supplementation, 3) 7th day of treatment - before the performance test, 4) 7th day of treatment - immediately after the performance test
Secondary Changes in anabolic hormones Blood serum will be obtained to measure testosterone concentration 1) baseline - 2) 7th day of treatment - before the supplementation, 3) 7th day of treatment - before the performance test, 4) 7th day of treatment - immediately after the performance test
Secondary Changes in catabolic hormones Blood serum will be obtained to measure cortisol concentration 1) baseline - 2) 7th day of treatment - before the supplementation, 3) 7th day of treatment - before the performance test, 4) 7th day of treatment - immediately after the performance test
Secondary Changes in kidney function markers Blood serum will be obtained to measure creatinine concentration 1) baseline - 2) 7th day of treatment - before the supplementation, 3) 7th day of treatment - before the performance test, 4) 7th day of treatment - immediately after the performance test
Secondary Changes in the purine metabolism marker Blood serum will be obtained to measure uric acid concentration 1) baseline - 2) 7th day of treatment - before the supplementation, 3) 7th day of treatment - before the performance test, 4) 7th day of treatment - immediately after the performance test
Secondary Changes in hemoglobin concentration Arterialized blood will be obtained to measure hemoglobin concentration 1) Before the performance test 2) 3 minutes after the performance test 3) 10 minutes after the performance test 4) 20 minutes after the performance test
Secondary Changes in hematocrit Arterialized blood will be obtained to measure hematocrit 1) Before the performance test 2) 3 minutes after the performance test 3) 10 minutes after the performance test 4) 20 minutes after the performance test
Secondary Changes in plasma volume The change in plasma volume will be calculated using the hemoglobin and hematocrit results 1) Before the performance test 2) 3 minutes after the performance test 3) 10 minutes after the performance test 4) 20 minutes after the performance test
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