NCT06043089

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 23, 2023

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 5, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2023

Completed
Last Updated

February 1, 2024

Status Verified

January 1, 2024

Enrollment Period

2 months

First QC Date

September 5, 2023

Last Update Submit

January 31, 2024

Conditions

Outcome Measures

Primary Outcomes (18)

  • Performance test

    yo-yo intermittent recovery test level 1

    7 days after treatment

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • Objective Sleep - Time in bed

    Total time spent in bed during the night assessed by sleep radar

    nights 1 - 7 during treatment

  • 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

  • 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

  • Objective Sleep - Light sleep

    Total amount of time in light sleep assessed by sleep radar

    nights 1 - 7 during treatment

  • Objective Sleep - Deep sleep

    Total amount of time in deep sleep assessed by sleep radar

    nights 1 - 7 during treatment

  • Objective Sleep - REM sleep

    Total amount of time in REM sleep assessed by sleep radar

    nights 1 - 7 during treatment

  • 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 Outcomes (17)

  • Countermovement jump height

    7 days after treatment

  • Ball speed velocity

    7 days after treatment

  • Sprint test (0-20m)

    7 days after treatment

  • Agility T-test

    7 days after treatment

  • Maximal isometric handgrip strength

    7 days after treatment

  • +12 more secondary outcomes

Study Arms (2)

Placebo group

PLACEBO COMPARATOR

Athletes received 7 days of placebo (2 × 70 mL of water with beetroot powder with negligible nitrate content).

Dietary Supplement: Beetroot juice supplementation or placebo

Beetroot group

EXPERIMENTAL

Athletes received 7 days of beetroot juice (2 × 70 mL of beetroot juice ∼12.9 mmol NO3-; Beet It, James White Drinks, Ipswich, UK).

Dietary Supplement: Beetroot juice supplementation or placebo

Interventions

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).

Beetroot groupPlacebo group

Eligibility Criteria

Age14 Years - 23 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • male
  • good general health assessed by physician
  • highly trained
  • written consent to participate

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University School of Physical Education in Cracow

Krakow, 31-571, Poland

Location

Study Officials

  • Aleksandra Filip-Stachnik, Phd

    University of Physcial Education in Cracow

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2023

First Posted

September 21, 2023

Study Start

August 23, 2023

Primary Completion

October 16, 2023

Study Completion

October 16, 2023

Last Updated

February 1, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations