Exercise PerformanceNCT03616093
The Impact of Acute (2 h) and Short-term (4 Days) Nitrate Supplementation in the Form of Red Beet Root Juice on Intense Intermittent Exercise Performance.
A study testing Test Beet Shot in people with Exercise Performance, run by PepsiCo Global R&D at 1 site in United Kingdom.
Trial summary
Both acute ingestion (1-3 h) and chronic supplementation (3-30 days) with dietary nitrate has been shown to increase nitric oxide activity and, in some studies, to improve exercise economy, exercise tolerance, and endurance exercise performance. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Exercise Performance
- What is being tested?
- Test Beet Shot
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Sep 2017to 31 May 2018
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male, physically active, intermittent team sport players, in self-reported good general health as assessed by the standard procedures described below and specifically meeting the following: blood pressure (BP), systolic 100-135 mmHg and diastolic 60-90 mmHg, and; body mass index (BMI) 16-29.9.
- 18-35 years of age
- Participants must participate in an intermittent exercise based sport (e.g. soccer, rugby, hockey), at a competitive level (i.e. competes in officiated matches/games).
- Understanding of the procedures to be undertaken as part of the study
- Willingness to participate in exercise testing and follow supplementation guidelines and other instructions provided by the experimenter
- Informed, voluntary, written consent to participate in the study
Who cannot join
- Known pulmonary, cardiovascular or metabolic disease
- Food allergies including phenylketonurea (PKU)
- Current regular use of any dietary supplement (excluding macronutrient based supplements) or previous use of any dietary supplement in the past 6 months that is known to have a lasting effect.
- Blood donation within 3 months prior to the start of the study
- Substance abuse within 2 years of the start of the study
- Smoking
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- Any prescription and non-prescription medication which may impact saliva production (antidepressants, diuretics, analgesics, antihistamines, anti-hyper/hypo-tensives, anti-anxiety, appetite suppressants).
- Current or previous use of phosphodiesterase 5 (PDE5) inhibitors.
- Participation in another clinical trial within past 4 weeks and/or participation in a PepsiCo trial within the last 6 months.
- Chronic use (6 months) of any antibacterial mouthwash products.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Exeter, Sport and Health Sciences department,
Exeter
About this study
Both acute ingestion (1-3 h) and chronic supplementation (3-30 days) with dietary nitrate has been shown to increase nitric oxide activity and, in some studies, to improve exercise economy, exercise tolerance, and endurance exercise performance. In addition, more recent evidence suggests that dietary nitrate has the potential to enhance team-sport-specific high-intensity intermittent exercise performance. Indeed, chronic dietary nitrate supplementation (2-6 days) has been reported to increase the distance covered before exhaustion during the Yo-Yo intermittent recovery level 1 test, a well-established and ecologically valid test widely used to mimic the high-intensity running bouts of soccer match-play. However, while these findings suggest that nitrate may be an effective ergogenic aid for team-sport players when consumed daily, it is currently unclear if the improvement in team-sport specific intermittent exercise performance can be achieved following a single bolus of dietary nitrate. Given the increasing interest and use of dietary nitrate as an ergogenic aid by team-sport players, establishing the shortest period of supplementation required to elicit an ergogenic effect is important in order to guide athletes on optimal supplementation strategies.
Given that a single bolus of dietary nitrate has previously been shown to improve exercise tolerance and endurance exercise performance, and an improved Yo-Yo IR1 performance has been observed after chronic nitrate supplementation, the investigator hypothesizes that acute (2 h) and short-term (4 days) nitrate supplementation will significantly elevate nitric oxide activity (measured as an increase in plasma nitrite concentration and skeletal muscle nitrate concentration) and improve performance during the Yo-Yo IR1 test (measured as an increased in distance covered (m) during the test at the point of volitional exhaustion) to a similar extent, when compared to a placebo.
- Conditions
- Exercise Performance
- Being tested
- Test Beet Shot, Placebo Beverage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test Beet ShotOther
Active supplement containing 6.2 mmol nitrate
Placebo BeverageOther
Placebo supplement containing negligible nitrate
| Study group | Role | What they receive |
|---|---|---|
| Test Beet shot | Experimental | Active supplement containing 6.2 mmol nitrate Receives: Other: Test Beet Shot |
| Placebo beverage | Placebo comparator | Placebo supplement containing negligible nitrate Receives: Other: Placebo Beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance covered during high-intensity intermittent exercise performance
Measured: 4 days
Distance covered during high-intensity intermittent exercise performance
Measured: 2 hours
Secondary outcomes (2)
Plasma nitrate concentrations
Measured: 4 days
Nitrite concentrations
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start30 Sep 2017
- Primary completion1 May 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise PerformanceStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- PepsiCo Global R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03616093
- Sponsor's protocol ID
- PEP-1718
- Status last verified
- Aug 2018
- First submitted
- 6 Jun 2018
- Last updated
- 6 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Acute (2 h) and Short-term (4 Days) Nitrate Supplementation in the Form of Red Beet Root Juice on Intense Intermittent Exercise Performance.
- ClinicalTrials.gov ID
- NCT03616093
- Acronym / sponsor ID
- PEP-1718
- Conditions
- Exercise Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2017 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 6 Aug 2018 (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.
Both acute ingestion (1-3 h) and chronic supplementation (3-30 days) with dietary nitrate has been shown to increase nitric oxide activity and, in some studies, to improve exercise economy, exercise tolerance, and endurance exercise performance. In addition, more recent evidence suggests that dietary nitrate has the potential to enhance team-sport-specific high-intensity intermittent exercise performance. Indeed, chronic dietary nitrate supplementation (2-6 days) has been reported to increase the distance covered before exhaustion during the Yo-Yo intermittent recovery level 1 test, a well-established and ecologically valid test widely used to mimic the high-intensity running bouts of soccer match-play. However, while these findings suggest that nitrate may be an effective ergogenic aid for team-sport players when consumed daily, it is currently unclear if the improvement in team-sport specific intermittent exercise performance can be achieved following a single bolus of dietary nitrate. Given the increasing interest and use of dietary nitrate as an ergogenic aid by team-sport players, establishing the shortest period of supplementation required to elicit an ergogenic effect is important in order to guide athletes on optimal supplementation strategies.
Given that a single bolus of dietary nitrate has previously been shown to improve exercise tolerance and endurance exercise performance, and an improved Yo-Yo IR1 performance has been observed after chronic nitrate supplementation, the investigator hypothesizes that acute (2 h) and short-term (4 days) nitrate supplementation will significantly elevate nitric oxide activity (measured as an increase in plasma nitrite concentration and skeletal muscle nitrate concentration) and improve performance during the Yo-Yo IR1 test (measured as an increased in distance covered (m) during the test at the point of volitional exhaustion) to a similar extent, when compared to a placebo.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Beet shot | Experimental | Other: Test Beet ShotActive supplement containing 6.2 mmol nitrate |
| Placebo beverage | Placebo comparator | Other: Placebo BeveragePlacebo supplement containing negligible nitrate |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male, physically active, intermittent team sport players, in self-reported good general health as assessed by the standard procedures described below and specifically meeting the following: blood pressure (BP), systolic 100-135 mmHg and diastolic 60-90 mmHg, and; body mass index (BMI) 16-29.9.
- 18-35 years of age
- Participants must participate in an intermittent exercise based sport (e.g. soccer, rugby, hockey), at a competitive level (i.e. competes in officiated matches/games).
- Understanding of the procedures to be undertaken as part of the study
- Willingness to participate in exercise testing and follow supplementation guidelines and other instructions provided by the experimenter
Key exclusion criteria (10 listed)
- Known pulmonary, cardiovascular or metabolic disease
- Food allergies including phenylketonurea (PKU)
- Current regular use of any dietary supplement (excluding macronutrient based supplements) or previous use of any dietary supplement in the past 6 months that is known to have a lasting effect.
- Blood donation within 3 months prior to the start of the study
- Substance abuse within 2 years of the start of the study
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 |
|---|---|---|
| Test Beet ShotActive supplement containing 6.2 mmol nitrate | Other | Test Beet shot |
| Placebo BeveragePlacebo supplement containing negligible nitrate | Other | Placebo beverage |
Primary outcome
Distance covered during high-intensity intermittent exercise performance
Time frame: 4 days
Distance covered during high-intensity intermittent exercise performance
Time frame: 2 hours
2 secondary outcomes
Plasma nitrate concentrations
Time frame: 4 days
Nitrite concentrations
Time frame: 2 hours
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 6 Aug 2018.
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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 Test Beet Shot in people with Exercise Performance, run by PepsiCo Global R&D 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 6 inclusion and 10 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 6 Aug 2018. 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?
Distance covered during high-intensity intermittent exercise performance (time frame: 4 days). 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?
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 6 Aug 2018; AzTrials last refreshed its copy on 7 Nov 2026.