NCT05993715

Brief Summary

This study aimed to assess if nitrate supplementation influence motor unit (MU) activity following a sustained ischemic contraction and whether this is affected by blood flow restriction (BFR) during the recovery period. Fourteen male participants (mean ± SD, 25 ± 6 years) completed two experimental trials following 5-days of supplementation with either nitrate-rich (NIT) or nitrate-depleted (PLA) beetroot juice in a randomized, double-blinded, cross-over design. Intramuscular electromyography was used to assess MU potential (MUP) size and firing rates (MUFR) during a submaximal (25% MVC) sustained isometric contraction with BFR. These variables were also assessed during a 90 s recovery period with the first half completed with, and the second half completed without, BFR. Nitrate supplementation can expedite the recovery of MUP duration following a sustained ischemic contraction in healthy adults. These novel observations improve understanding of the effects of nitrate on the recovery of neuromuscular function post-exercise and might have implications for recovery of muscle contractile function.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2019

Shorter than P25 for not_applicable

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

December 4, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2020

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

June 20, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 15, 2023

Completed
Last Updated

August 15, 2023

Status Verified

August 1, 2023

Enrollment Period

2 months

First QC Date

June 20, 2023

Last Update Submit

August 8, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Plasma Nitrite Level

    concentration \[nmol\]

    Pre-exercise

  • Motor Unit Activity

    Duration (ms), area (uV.ms), firing rate (Hz)

    Pre-exercise, post-exercise, recovery (45 s)

Study Arms (2)

Nitrate supplementation

EXPERIMENTAL

2 × 70 mL/day shots of concentrate nitrae-rich (\~12.8 mmol/day NO3-) beetroot juice. Two shots were supplemented for 5 days; one each morning (\~9 am) and one each evening (\~9 pm) except for the day of the experimental trial when both shots were taken together 2.5 h before the experimental trial.

Dietary Supplement: Nitrate supplementation

Placebo supplementation

PLACEBO COMPARATOR

2 × 70 mL/day shots of concentrate nitrate-depleted (\~0.08 mmol/day NO3-) beetroot juice. Two shots were supplemented for 5 days; one each morning (\~9 am) and one each evening (\~9 pm) except for the day of the experimental trial when both shots were taken together 2.5 h before the experimental trial.

Dietary Supplement: Placebo supplementtaion

Interventions

Nitrate supplementationDIETARY_SUPPLEMENT

Participants ingested 2 × 70 mL/day shots of concentrate nitrate-rich (\~12.8 mmol/day nitrate) or nitrate-depleted (\~0.08 mmol/day nitrite) beetroot juice (Beet It, James White Drinks Ltd., Ipswich, UK). Two shots were supplemented for 5 days; one each morning (\~9 am) and one each evening (\~9 pm) except for the day of the experimental trial when both shots were taken together 2.5 h before the experimental trial.

Nitrate supplementation
Placebo supplementtaionDIETARY_SUPPLEMENT

2 × 70 mL/day shots of concentrate nitrate-depleted (\~0.08 mmol/day NO3-) beetroot juice. Two shots were supplemented for 5 days; one each morning (\~9 am) and one each evening (\~9 pm) except for the day of the experimental trial when both shots were taken together 2.5 h before the experimental trial.

Placebo supplementation

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male between 18 - 30 years
  • free from known respiratory insufficiency, cardiovascular disease and neuro-musculo-skeletal problems at present or in the preceding 6 months.
  • having at least 5 years competitively (team) sport experience.

You may not qualify if:

  • having cardiovascular disease, neuromuscular disease and any lower limb injury and treatment for chronic respiratory complaints.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northumbria University

Newcastle upon Tyne, United Kingdom

Location

Related Publications (1)

  • Esen O, Bailey SJ, Stashuk DW, Howatson G, Goodall S. Influence of nitrate supplementation on motor unit activity during recovery following a sustained ischemic contraction in recreationally active young males. Eur J Nutr. 2024 Sep;63(6):2379-2387. doi: 10.1007/s00394-024-03440-9. Epub 2024 May 29.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Supplements were allocated in a randomised order and double-blind design by an independent technician who had no further involvement in this study. The randomization and blinding were held until the end of the study.
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 20, 2023

First Posted

August 15, 2023

Study Start

December 4, 2019

Primary Completion

February 3, 2020

Study Completion

March 1, 2020

Last Updated

August 15, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations