Dietary SupplementsNCT05993715
Nitrate Supplementation on Motor Unit Activity
A study testing Nitrate supplementation in people with Dietary Supplements and Healthy, run by Northumbria University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Dietary Supplements, Healthy
- What is being tested?
- Nitrate supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Dec 2019to 1 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- having cardiovascular disease, neuromuscular disease and any lower limb injury and treatment for chronic respiratory complaints.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Nitrate Supplementation on Motor Unit Activity During Recovery Following a Sustained Ischemic Contraction.
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.
- Conditions
- Dietary Supplements, Healthy
- Being tested
- Nitrate supplementation, Placebo supplementtaion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Placebo supplementtaion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Nitrite Level
concentration [nmol]
Measured: Pre-exercise
Motor Unit Activity
Duration (ms), area (uV.ms), firing rate (Hz)
Measured: Pre-exercise, post-exercise, recovery (45 s)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start4 Dec 2019
- Primary completion3 Feb 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dietary SupplementsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Collaborators
- Manchester Metropolitan University
- Responsible party
- Principal investigator, Dr Ozcan Esen, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05993715
- Sponsor's protocol ID
- 5951
- Status last verified
- Aug 2023
- First submitted
- 20 Jun 2023
- Last updated
- 15 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38809323
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Nitrate Supplementation on Motor Unit Activity During Recovery Following a Sustained Ischemic Contraction.
- ClinicalTrials.gov ID
- NCT05993715
- Acronym / sponsor ID
- 5951
- Conditions
- Dietary Supplements, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Collaborators
- Manchester Metropolitan University
- Study start
- 4 Dec 2019 (actual)
- Primary completion
- 3 Feb 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 15 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nitrate supplementation | Experimental | Dietary Supplement: Nitrate supplementation2 × 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. |
| Placebo supplementation | Placebo comparator | Dietary Supplement: Placebo supplementtaion2 × 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- having cardiovascular disease, neuromuscular disease and any lower limb injury and treatment for chronic respiratory complaints.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitrate supplementationParticipants 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. | Dietary supplement | Nitrate supplementation |
| Placebo supplementtaion2 × 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 supplementation |
Primary outcome
Plasma Nitrite Level
Time frame: Pre-exercise
concentration [nmol]
Motor Unit Activity
Time frame: Pre-exercise, post-exercise, recovery (45 s)
Duration (ms), area (uV.ms), firing rate (Hz)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
- Derived from this study: PubMed 38809323Esen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nitrate supplementation in people with Dietary Supplements and Healthy, run by Northumbria University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma Nitrite Level (time frame: Pre-exercise). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05993715, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2023.