PerformanceNCT02162927
Dietary Nitrate Supplementation and Crossfit Athletes
A study testing Dietary Nitrate in people with Performance, run by Florida State University at 2 sites in United States.
Trial summary
In the past, dietary nitrate supplementation has been shown to have clinical benefits in the treatment of cardiovascular issues. More recently, however, the focus of nitrate supplementation has shifted to focus of human performance, and has shown to increase the time to exhaustion during maximal intensity exercise and… Read more about this study
- Who is it for?
- Ages 20 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Performance
- What is being tested?
- Dietary Nitrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2014to Nov 2014
- 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 20 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- College-aged male CrossFit between the ages of 20 and 35 years (yr), a peak maximum oxygen uptake (VO2peak) of at least 50 ml/kg/min will be recruited to participate in this study.
Who cannot join
- Having any thyroid and/or kidney diseases that could affect NO synthesis and/or metabolism, any illness, smoking, taking other medications, injured, not well-trained (as noted by the VO2peak), consuming any other supplements at the time of the study except protein or multivitamin, allergic to any component of the supplement, including tree nuts, in case of potential packaging mixing and contamination. Women and children as well are excluded.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
CrossFit Blackbox
Tallahassee, Florida, 32301
Florida State University
Tallahassee, Florida
About this study
Official title: The Effects of Six-day Dietary Nitrate Supplementation on Strength and Endurance Measurements in Male CrossFit Athletes
In the past, dietary nitrate supplementation has been shown to have clinical benefits in the treatment of cardiovascular issues. More recently, however, the focus of nitrate supplementation has shifted to focus of human performance, and has shown to increase the time to exhaustion during maximal intensity exercise and lower the cost of oxygen consumption during submaximal intensity exercise. Acutely, nitrate supplementation in the form of beetroot juice has been shown to increase strength measurements, as well as increase the time to complete a 2000 meter rowing ergometer test. However, to the author's knowledge, there are no studies that link the relationship between multi-day nitrate supplementation and the rowing test or the nitrate's effect on strength when in the salt form. Additionally, to the author's knowledge, no evidence has been published which relates dietary nitrate supplementation and its effects on a CrossFit circuit workout.
Our central hypothesis is that six days of dietary nitrate supplementation will improve strength, endurance, a power more than a placebo in male CrossFit athletes.
Read the detailed description
The purpose of this randomized, double-blind, crossover study is to identify if dietary nitrate supplementation improves strength , endurance, and power measurements in male CrossFit athletes. Specifically, the strength measurements will be taken using isometric and isokinetic tests on the Biodex dynamometer. Endurance will be measured using time trials for a 2000 meter rowing test and the "Fran" CrossFit workout. Finally, power will be analyzed using the Wingate cycle test.
The treatment group will receive 1 serving of f potassium nitrate KNO3- (N) (8 mmols NO3-). The placebo group will receive 1 serving of the nitrate-free placebo (PL) potassium chloride (8 mmol KCl).
The participants will complete two three-day baseline testing, with a six-day supplementation period following each round of baseline testing. Following the first six-day supplementation period, there will be a 10 day washout period before the second baseline testing begins.
- Conditions
- Performance
- Being tested
- Dietary Nitrate, Potassium Chloride (placebo)
- Keywords
- muscular strength, muscular endurance, muscular power, rowing, CrossFit, dietary nitrate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary NitrateDietary supplement
This pill must be taken on an empty stomach (2-3 hours after eating) and must be taken about 2-3 hours before exercise.
Potassium Chloride (placebo)Dietary supplement
This pill must be taken on an empty stomach (2-3 hours after eating) and must be taken about 2-3 hours before exercise.
| Study group | Role | What they receive |
|---|---|---|
| Potassium Nitrate (N) | Experimental | This involves 1 serving (2 pills) of potassium nitrate KNO3- (N) (8 mmols NO3-). The supplementation period is six days. This pill must be taken on an empty stomach (2-3 hours after eating) and must be taken about 2-3 hours before exercise. Receives: Dietary Supplement: Dietary Nitrate |
| Potassium Chloride | Placebo comparator | This involves 1 serving (2 pills) of the nitrate-free placebo (PL) potassium chloride (8 mmol KCl) for a six-day supplementation period. This pill must be taken on an empty stomach (2-3 hours after eating) and must be taken about 2-3 hours before exercise. Receives: Dietary Supplement: Potassium Chloride (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscular Strength
Muscular Strength will be tested using the isometric and isokinetic strength tests.
Measured: During 1 month of study
Muscular Endurance
Endurance will be tested using the 2000 meter rowing ergometer test and CrossFit circuit known as "Fran".
Measured: 1 month
Muscular Power
Power will be measured using the Wingate cycle test.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2014 (estimated)
- Study startAug 2014
- Primary completionOct 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PerformanceStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael J. Ormsbee, Florida State University
- Investigators
- Michael Ormsbee, PhD, Principal investigator, Florida State UniversitySamuel J Kramer, BS, Study director, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02162927
- Sponsor's protocol ID
- HSC2014
- Status last verified
- Mar 2015
- First submitted
- 9 Jun 2014
- Last updated
- 4 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Six-day Dietary Nitrate Supplementation on Strength and Endurance Measurements in Male CrossFit Athletes
- ClinicalTrials.gov ID
- NCT02162927
- Acronym / sponsor ID
- HSC2014
- Conditions
- Performance
- Keywords
- muscular strength, muscular endurance, muscular power, rowing, CrossFit, dietary nitrate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 13 Jun 2014 (estimated)
- 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.
In the past, dietary nitrate supplementation has been shown to have clinical benefits in the treatment of cardiovascular issues. More recently, however, the focus of nitrate supplementation has shifted to focus of human performance, and has shown to increase the time to exhaustion during maximal intensity exercise and lower the cost of oxygen consumption during submaximal intensity exercise. Acutely, nitrate supplementation in the form of beetroot juice has been shown to increase strength measurements, as well as increase the time to complete a 2000 meter rowing ergometer test. However, to the author's knowledge, there are no studies that link the relationship between multi-day nitrate supplementation and the rowing test or the nitrate's effect on strength when in the salt form. Additionally, to the author's knowledge, no evidence has been published which relates dietary nitrate supplementation and its effects on a CrossFit circuit workout.
Our central hypothesis is that six days of dietary nitrate supplementation will improve strength, endurance, a power more than a placebo in male CrossFit athletes.
Detailed description
The purpose of this randomized, double-blind, crossover study is to identify if dietary nitrate supplementation improves strength , endurance, and power measurements in male CrossFit athletes. Specifically, the strength measurements will be taken using isometric and isokinetic tests on the Biodex dynamometer. Endurance will be measured using time trials for a 2000 meter rowing test and the "Fran" CrossFit workout. Finally, power will be analyzed using the Wingate cycle test.
The treatment group will receive 1 serving of f potassium nitrate KNO3- (N) (8 mmols NO3-). The placebo group will receive 1 serving of the nitrate-free placebo (PL) potassium chloride (8 mmol KCl).
The participants will complete two three-day baseline testing, with a six-day supplementation period following each round of baseline testing. Following the first six-day supplementation period, there will be a 10 day washout period before the second baseline testing begins.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Potassium Nitrate (N) | Experimental | Dietary Supplement: Dietary NitrateThis involves 1 serving (2 pills) of potassium nitrate KNO3- (N) (8 mmols NO3-). The supplementation period is six days. This pill must be taken on an empty stomach (2-3 hours after eating) and must be taken about 2-3 hours before exercise. |
| Potassium Chloride | Placebo comparator | Dietary Supplement: Potassium Chloride (placebo)This involves 1 serving (2 pills) of the nitrate-free placebo (PL) potassium chloride (8 mmol KCl) for a six-day supplementation period. This pill must be taken on an empty stomach (2-3 hours after eating) and must be taken about 2-3 hours before exercise. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- College-aged male CrossFit between the ages of 20 and 35 years (yr), a peak maximum oxygen uptake (VO2peak) of at least 50 ml/kg/min will be recruited to participate in this study.
Key exclusion criteria (1 listed)
- Having any thyroid and/or kidney diseases that could affect NO synthesis and/or metabolism, any illness, smoking, taking other medications, injured, not well-trained (as noted by the VO2peak), consuming any other supplements at the time of the study except protein or multivitamin, allergic to any component of the supplement, including tree nuts, in case of potential packaging mixing and contamination. Women and children as well are excluded.
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 |
|---|---|---|
| Dietary NitrateThis pill must be taken on an empty stomach (2-3 hours after eating) and must be taken about 2-3 hours before exercise. | Dietary supplement | Potassium Nitrate (N) |
| Potassium Chloride (placebo)This pill must be taken on an empty stomach (2-3 hours after eating) and must be taken about 2-3 hours before exercise. | Dietary supplement | Potassium Chloride |
Primary outcome
Muscular Strength
Time frame: During 1 month of study
Muscular Strength will be tested using the isometric and isokinetic strength tests.
Muscular Endurance
Time frame: 1 month
Endurance will be tested using the 2000 meter rowing ergometer test and CrossFit circuit known as "Fran".
Muscular Power
Time frame: 1 month
Power will be measured using the Wingate cycle test.
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 4 Mar 2015.
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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.
Michael Ormsbee, PhD principal investigator
Florida State University
Samuel J Kramer, BS study director
Florida State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Nitrate in people with Performance, run by Florida State University at 2 sites 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: finished, as of the sponsor's last update on 4 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Muscular Strength (time frame: During 1 month of study). The study lists 3 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 4 Mar 2015.