High Nitrate DoseNCT05957835
The Effect of Beetroot Juice Supplementation Dose on Neuromuscular Performance During Resistance Exercise
A study testing BR-HIGH, BR-MOD and BR-LOW in people with High Nitrate Dose and Moderate Nitrate Dose, run by Pepperdine University at 1 site in United States.
Trial summary
Dietary nitrate supplementation, administered in the form of nitrate-rich beetroot juice, has been shown to improve exercise performance and may have more pronounced effects on exercise that requires high-power and high-velocity muscle contraction such as weightlifting and body-mass resisted exercise (i.e, resistance… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- High Nitrate Dose, Moderate Nitrate Dose, Low Nitrate Dose
- What is being tested?
- BR-HIGH, BR-MOD and BR-LOW
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2023to 30 Jun 2024
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Recreationally active males who performed resistance exercise at least twice weekly for the last two years
Who cannot join
- individuals with contraindications to exercise, cardiometabolic disease, currently consuming dietary supplements containing caffeine, sodium bicarbonate, creatine, beta-alanine, and/or NO precursor supplements (i.e., NO3-, arginine, citrulline, antioxidants), females, and smokers
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Pepperdine University
Malibu, California, 90263
Rachel Tan, PhD, 310-506-7041, rachel.tan@pepperdine.edu
About this study
Dietary nitrate supplementation, administered in the form of nitrate-rich beetroot juice, has been shown to improve exercise performance and may have more pronounced effects on exercise that requires high-power and high-velocity muscle contraction such as weightlifting and body-mass resisted exercise (i.e, resistance exercise). However, limited data are available that have examined the potential performance enhancing effect of beetroot juice in resistance exercise. Moreover, there is no information on the dose of nitrate required for performance enhancing effects during resistance exercise which limits its widespread use to enhance performance. Therefore, the investigators will assess if supplementing the diet with nitrate-rich beetroot juice impacts resistance exercise performance (e.g., power, velocity), when compared to supplementing the diet with nitrate-depleted beetroot juice (i.e. placebo). The investigators will also investigate the dose-response effect of beetroot juice on resistance exercise performance by providing a low, moderate, and high nitrate dose of concentrated beetroot juice. The results of this study will improve understanding of whether beetroot juice influences resistance exercise performance and will provide insight on whether different doses of beetroot juice influence the efficacy of nitrate supplementation on resistance exercise performance. Together, these data will guide supplementation strategies for enhancing resistance exercise performance.
Read the detailed description
Supplementation with inorganic nitrate, which is most commonly administered in the form of concentrated nitrate-rich beetroot juice shots, has emerged as an ergogenic nutritional strategy. Beetroot juice ingestion has been reported to enhance endurance and high-intensity intermittent exercise performance in running and cycling. These improvements are attributed to augmented muscle contractility, force production and blood flow distribution, specifically in muscle groups comprised predominantly of type II muscle fibers. Together, such changes provide a strong physiological rationale supporting the potential for dietary nitrate to enhance high-power and high-velocity muscle contractions since type II muscle fibers are heavily activated during these tasks. However, the influence of dietary nitrate on resistance exercise performance is substantially underdeveloped with most previous studies having assessed the effect of nitrate supplementation on running and cycling endurance and high-intensity intermittent exercise. Moreover, there is no information on the dose of nitrate required to evoke ergogenic effects during resistance exercise, which greatly hinders the potential implementation of beetroot juice as a research-informed performance enhancing supplement for resistance exercise. Thus, the proposed project will investigate if acute dietary nitrate ingestion, provided as nitrate-rich beetroot juice, elicits improvements in various neuromuscular performance parameters (e.g., power, velocity) during resistance exercise performance when compared to supplementing the diet with a nitrate-depleted beetroot juice placebo. The investigators will also investigate the dose-response effect of beetroot juice on resistance exercise performance by providing low (70 ml i.e., ~6.5 mmol or ~400 mg of nitrate), moderate (140 ml i.e., ~13 mmol or ~800 mg of nitrate) and a high nitrate dose (280 ml i.e., ~26 mmol or ~1600 mg of nitrate) of concentrated beetroot juice. This project will provide insight to practitioners (coaches/athletes) aiming to enhance performance in settings where muscular power and speed are key determinants for success, as well as to scientists exploring the efficacy of beetroot juice as a form of dietary nitrate supplementation to improve muscle contractile function.
- Being tested
- BR-HIGH, BR-MOD, BR-LOW, PL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BR-HIGHDietary supplement
4 x nitrate-rich beetroot juice shots (26 mmol of nitrate)
BR-MODDietary supplement
2 x nitrate-rich beetroot juice shots + 2 x nitrate-depleted beetroot juice shot (12 mmol of nitrate)
BR-LOWDietary supplement
1 x nitrate-rich beetroot juice shot + 3 x nitrate-depleted beetroot juice shots (6 mmol of nitrate)
PLDietary supplement
4 x nitrate-depleted beetroot juice shots (0 mmol of nitrate)
| Study group | Role | What they receive |
|---|---|---|
| BR-HIGH | Experimental | Participants will ingest an elevated dose of nitrate 2.5 hours prior to exercise. Receives: Dietary Supplement: BR-HIGH |
| BR-MOD | Experimental | Participants will ingest a moderate dose of nitrate 2.5 hours prior to exercise. Receives: Dietary Supplement: BR-MOD |
| BR-LOW | Experimental | Participants will ingest a low dose of nitrate 2.5 hours prior to exercise. Receives: Dietary Supplement: BR-LOW |
| PL | Placebo comparator | Participants will ingest a negligible amount of nitrate 2.5 hours prior to exercise. Receives: Dietary Supplement: PL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma nitrate
Plasma nitrate concentrations in each condition from blood samples draw at rest prior to exercise, and analyzed using gas phase chemiluminescence
Measured: Through study completion, at least 1 year
Plasma nitrite
Plasma nitrite concentrations in each condition from blood samples draw at rest prior to exercise, and analyzed using gas phase chemiluminescence
Measured: Through study completion, at least 1 year
Neuromuscular performance during countermovement jumps
Peak force will be measured using a force place.
Measured: Through study completion, at least 1 year
Neuromuscular performance during countermovement jumps
average propulsion force will be measured using a force place.
Measured: Through study completion, at least 1 year
Neuromuscular performance during countermovement jumps
rate of power development will be measured using a force place.
Measured: Through study completion, at least 1 year
Neuromuscular performance during countermovement jumps
peak positive power will be measured using a force place.
Measured: Through study completion, at least 1 year
Neuromuscular performance during countermovement jumps
concentric mean power will be measured using a force place.
Measured: Through study completion, at least 1 year
Neuromuscular performance during countermovement jumps
jump height will be measured using a force place.
Measured: Through study completion, at least 1 year
Neuromuscular performance during countermovement jumps
takeoff velocity will be measured using a force place.
Measured: Through study completion, at least 1 year
Neuromuscular performance during countermovement jumps
flight time will be measured using a force place.
Measured: Through study completion, at least 1 year
Neuromuscular performance during countermovement jumps
Peak force, average propulsion force, rate of power development, peak positive power, concentric mean power, jump height, takeoff velocity, flight time will be measured using a force place.
Measured: Through study completion, at least 1 year
Peak power
Power will be measured using a linear transducer with the highest value will be recorded for peak power
Measured: Through study completion, at least 1 year
Mean power
Power will be measured using a linear transducer and will be averaged across sets for the determination of mean power
Measured: Through study completion, at least 1 year
Mean velocity
Velocity will be measured using a linear transducer and will be averaged across sets for the determination of mean velocity
Measured: Through study completion, at least 1 year
Peak velocity
Velocity will be measured using a linear transducer the highest value will be retained for peak velocity
Measured: Through study completion, at least 1 year
Secondary outcomes (1)
Mood
24 items representing six subscales (i.e., anger, confusion, depression, fatigue, tension, vigour; four-items per subscale) will be captured using a five-point Likert scale (i.e., 0 = not at all, 1 = a little, 2 = moderately, 3 = quite a bit, 4 = extremely)
Measured: Through study completion, at least 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start23 May 2023
- Primary completion28 Apr 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Nitrate DoseStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- In a double-blind, randomised, crossover design, participants were assigned to four experimental trials to consume a total of 4 beetroot juice shots during each condition: (a) 4 x 70 ml of nitrate-depleted beetroot juice for placebo (PL), (b) 1 x 70 ml of nitrate-rich beetroot juice 3 x 70 ml nitrate-depleted beetroot juice for a low dose of nitrate-rich beetroot juice (BR-LOW; \~6.5 mmol of nitrate total), (c) 2 x 70 of nitrate-rich beetroot juice and 2 x 70ml of nitrate depleted beetroot juice for a moderate dose of nitrate-rich beetroot juice (BR-MOD; \~13 mmol of nitrate total), and (d) 4 x 70 ml of nitrate-rich beetroot juice for an elevated dose of nitrate-rich beetroot juice (BR-HIGH; \~26 mmol of nitrate total).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pepperdine University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rachel Tan, Pepperdine University
- Investigators
- Rachel Tan, PhD, Principal investigator, Pepperdine University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05957835
- Sponsor's protocol ID
- RT12
- Status last verified
- Jun 2023
- First submitted
- 28 Jun 2023
- Last updated
- 24 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation, upon request.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Beetroot Juice Supplementation Dose on Neuromuscular Performance During Resistance Exercise
- ClinicalTrials.gov ID
- NCT05957835
- Acronym / sponsor ID
- RT12
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Pepperdine UniversityUniversity, hospital or other
- Study start
- 23 May 2023 (actual)
- Primary completion
- 28 Apr 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 24 Jul 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.
Dietary nitrate supplementation, administered in the form of nitrate-rich beetroot juice, has been shown to improve exercise performance and may have more pronounced effects on exercise that requires high-power and high-velocity muscle contraction such as weightlifting and body-mass resisted exercise (i.e, resistance exercise). However, limited data are available that have examined the potential performance enhancing effect of beetroot juice in resistance exercise. Moreover, there is no information on the dose of nitrate required for performance enhancing effects during resistance exercise which limits its widespread use to enhance performance. Therefore, the investigators will assess if supplementing the diet with nitrate-rich beetroot juice impacts resistance exercise performance (e.g., power, velocity), when compared to supplementing the diet with nitrate-depleted beetroot juice (i.e. placebo). The investigators will also investigate the dose-response effect of beetroot juice on resistance exercise performance by providing a low, moderate, and high nitrate dose of concentrated beetroot juice. The results of this study will improve understanding of whether beetroot juice influences resistance exercise performance and will provide insight on whether different doses of beetroot juice influence the efficacy of nitrate supplementation on resistance exercise performance. Together, these data will guide supplementation strategies for enhancing resistance exercise performance.
Detailed description
Supplementation with inorganic nitrate, which is most commonly administered in the form of concentrated nitrate-rich beetroot juice shots, has emerged as an ergogenic nutritional strategy. Beetroot juice ingestion has been reported to enhance endurance and high-intensity intermittent exercise performance in running and cycling. These improvements are attributed to augmented muscle contractility, force production and blood flow distribution, specifically in muscle groups comprised predominantly of type II muscle fibers. Together, such changes provide a strong physiological rationale supporting the potential for dietary nitrate to enhance high-power and high-velocity muscle contractions since type II muscle fibers are heavily activated during these tasks. However, the influence of dietary nitrate on resistance exercise performance is substantially underdeveloped with most previous studies having assessed the effect of nitrate supplementation on running and cycling endurance and high-intensity intermittent exercise. Moreover, there is no information on the dose of nitrate required to evoke ergogenic effects during resistance exercise, which greatly hinders the potential implementation of beetroot juice as a research-informed performance enhancing supplement for resistance exercise. Thus, the proposed project will investigate if acute dietary nitrate ingestion, provided as nitrate-rich beetroot juice, elicits improvements in various neuromuscular performance parameters (e.g., power, velocity) during resistance exercise performance when compared to supplementing the diet with a nitrate-depleted beetroot juice placebo. The investigators will also investigate the dose-response effect of beetroot juice on resistance exercise performance by providing low (70 ml i.e., ~6.5 mmol or ~400 mg of nitrate), moderate (140 ml i.e., ~13 mmol or ~800 mg of nitrate) and a high nitrate dose (280 ml i.e., ~26 mmol or ~1600 mg of nitrate) of concentrated beetroot juice. This project will provide insight to practitioners (coaches/athletes) aiming to enhance performance in settings where muscular power and speed are key determinants for success, as well as to scientists exploring the efficacy of beetroot juice as a form of dietary nitrate supplementation to improve muscle contractile function.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- In a double-blind, randomised, crossover design, participants were assigned to four experimental trials to consume a total of 4 beetroot juice shots during each condition: (a) 4 x 70 ml of nitrate-depleted beetroot juice for placebo (PL), (b) 1 x 70 ml of nitrate-rich beetroot juice 3 x 70 ml nitrate-depleted beetroot juice for a low dose of nitrate-rich beetroot juice (BR-LOW; ~6.5 mmol of nitrate total), (c) 2 x 70 of nitrate-rich beetroot juice and 2 x 70ml of nitrate depleted beetroot juice for a moderate dose of nitrate-rich beetroot juice (BR-MOD; ~13 mmol of nitrate total), and (d) 4 x 70 ml of nitrate-rich beetroot juice for an elevated dose of nitrate-rich beetroot juice (BR-HIGH; ~26 mmol of nitrate total).
| Arm | Type | Receives |
|---|---|---|
| BR-HIGH | Experimental | Dietary Supplement: BR-HIGHParticipants will ingest an elevated dose of nitrate 2.5 hours prior to exercise. |
| BR-MOD | Experimental | Dietary Supplement: BR-MODParticipants will ingest a moderate dose of nitrate 2.5 hours prior to exercise. |
| BR-LOW | Experimental | Dietary Supplement: BR-LOWParticipants will ingest a low dose of nitrate 2.5 hours prior to exercise. |
| PL | Placebo comparator | Dietary Supplement: PLParticipants will ingest a negligible amount of nitrate 2.5 hours prior to exercise. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Recreationally active males who performed resistance exercise at least twice weekly for the last two years
Key exclusion criteria (1 listed)
- individuals with contraindications to exercise, cardiometabolic disease, currently consuming dietary supplements containing caffeine, sodium bicarbonate, creatine, beta-alanine, and/or NO precursor supplements (i.e., NO3-, arginine, citrulline, antioxidants), females, and smokers
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 |
|---|---|---|
| BR-HIGH4 x nitrate-rich beetroot juice shots (26 mmol of nitrate) | Dietary supplement | BR-HIGH |
| BR-MOD2 x nitrate-rich beetroot juice shots + 2 x nitrate-depleted beetroot juice shot (12 mmol of nitrate) | Dietary supplement | BR-MOD |
| BR-LOW1 x nitrate-rich beetroot juice shot + 3 x nitrate-depleted beetroot juice shots (6 mmol of nitrate) | Dietary supplement | BR-LOW |
| PL4 x nitrate-depleted beetroot juice shots (0 mmol of nitrate) | Dietary supplement | PL |
Primary outcome
Plasma nitrate
Time frame: Through study completion, at least 1 year
Plasma nitrate concentrations in each condition from blood samples draw at rest prior to exercise, and analyzed using gas phase chemiluminescence
Plasma nitrite
Time frame: Through study completion, at least 1 year
Plasma nitrite concentrations in each condition from blood samples draw at rest prior to exercise, and analyzed using gas phase chemiluminescence
Neuromuscular performance during countermovement jumps
Time frame: Through study completion, at least 1 year
Peak force will be measured using a force place.
Neuromuscular performance during countermovement jumps
Time frame: Through study completion, at least 1 year
average propulsion force will be measured using a force place.
Neuromuscular performance during countermovement jumps
Time frame: Through study completion, at least 1 year
rate of power development will be measured using a force place.
Neuromuscular performance during countermovement jumps
Time frame: Through study completion, at least 1 year
peak positive power will be measured using a force place.
Neuromuscular performance during countermovement jumps
Time frame: Through study completion, at least 1 year
concentric mean power will be measured using a force place.
Neuromuscular performance during countermovement jumps
Time frame: Through study completion, at least 1 year
jump height will be measured using a force place.
Neuromuscular performance during countermovement jumps
Time frame: Through study completion, at least 1 year
takeoff velocity will be measured using a force place.
Neuromuscular performance during countermovement jumps
Time frame: Through study completion, at least 1 year
flight time will be measured using a force place.
Neuromuscular performance during countermovement jumps
Time frame: Through study completion, at least 1 year
Peak force, average propulsion force, rate of power development, peak positive power, concentric mean power, jump height, takeoff velocity, flight time will be measured using a force place.
Peak power
Time frame: Through study completion, at least 1 year
Power will be measured using a linear transducer with the highest value will be recorded for peak power
Mean power
Time frame: Through study completion, at least 1 year
Power will be measured using a linear transducer and will be averaged across sets for the determination of mean power
Mean velocity
Time frame: Through study completion, at least 1 year
Velocity will be measured using a linear transducer and will be averaged across sets for the determination of mean velocity
Peak velocity
Time frame: Through study completion, at least 1 year
Velocity will be measured using a linear transducer the highest value will be retained for peak velocity
1 secondary outcome
Mood
Time frame: Through study completion, at least 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- Individual participant dataSharing planned: No. The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation, upon request.
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.
Rachel Tan, PhD principal investigator
Pepperdine University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BR-HIGH, BR-MOD and BR-LOW in people with High Nitrate Dose and Moderate Nitrate Dose, run by Pepperdine University at 1 site in United States.
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 1 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: status not confirmed, as of the sponsor's last update on 24 Jul 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 States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rachel Tan, PhD (3105067041, rachel.tan@pepperdine.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma nitrate (time frame: Through study completion, at least 1 year). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2023.