Exercise PerformanceNCT03565523
The Effect of Dietary Nitrate Supplementation on Linear Running Sprint Performance, Agility and Vertical Jump Performance in a Rested and Fatigued State
A study testing Beetroot in people with Exercise Performance, run by PepsiCo Global R&D.
Trial summary
Dietary nitrate (NO3-) supplementation has been shown to improve skeletal muscle contractility and fatigue resistance, particularly in fast-twitch (type II) muscle fibers. Furthermore, NO3- supplementation has been shown to speed reaction time. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise Performance
- What is being tested?
- Beetroot
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2016to 30 Apr 2017
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female participants in self-reported good general health as assessed by the standard procedures described below and specifically meeting normal blood pressure range (systolic: 100-135, diastolic: 60-90) and body mass index (BMI) range (16.0-29.9)
- Range of 18-45 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
Show all 9Show fewer
- 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.
About this study
Dietary nitrate (NO3-) supplementation has been shown to improve skeletal muscle contractility and fatigue resistance, particularly in fast-twitch (type II) muscle fibers. Furthermore, NO3- supplementation has been shown to speed reaction time. Taken together, these findings suggest that NO3- ingestion may be ergogenic during all-out sprint running and reactive agility tasks. Moreover, increasing muscle force production at high contraction speeds would be expected to translate into improved muscle power and, subsequently, improved performance in very explosive forms of exercise, such as vertical jumping. Therefore, the purpose of this investigation is to assess the effect of short term (5 days) NO3- supplementation on linear running sprint performance, reactive agility and vertical jump performance in a rested and fatigued state.
- Conditions
- Exercise Performance
- Being tested
- Beetroot, Placebo beverage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BeetrootOther
Containing 385 mg nitrate
Placebo beverageOther
<0.1 mmol nitrate in sucrose solution with beet coloring
| Study group | Role | What they receive |
|---|---|---|
| Test Beet shot | Experimental | Containing 385 mg nitrate Receives: Other: Beetroot |
| Placebo beverage | Placebo comparator | <0.1 mmol nitrate in sucrose solution with beet coloring Receives: Other: Placebo beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Linear running sprint time
Linear running sprint in a rested and fatigued state
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2018
- Study start1 Sep 2016
- Primary completion31 Mar 2017
- Study completion30 Apr 2017
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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- PepsiCo Global R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andy Jones, PhD, Principal investigator, University of Exeter, Sport and Health Sciences department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03565523
- Sponsor's protocol ID
- PEP-1607
- Status last verified
- Jun 2018
- First submitted
- 6 Jun 2018
- Last updated
- 21 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dietary Nitrate Supplementation on Linear Running Sprint Performance, Agility and Vertical Jump Performance in a Rested and Fatigued State
- ClinicalTrials.gov ID
- NCT03565523
- Acronym / sponsor ID
- PEP-1607
- Conditions
- Exercise Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 30 Apr 2017 (actual)
- First posted
- 21 Jun 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.
Dietary nitrate (NO3-) supplementation has been shown to improve skeletal muscle contractility and fatigue resistance, particularly in fast-twitch (type II) muscle fibers. Furthermore, NO3- supplementation has been shown to speed reaction time. Taken together, these findings suggest that NO3- ingestion may be ergogenic during all-out sprint running and reactive agility tasks. Moreover, increasing muscle force production at high contraction speeds would be expected to translate into improved muscle power and, subsequently, improved performance in very explosive forms of exercise, such as vertical jumping. Therefore, the purpose of this investigation is to assess the effect of short term (5 days) NO3- supplementation on linear running sprint performance, reactive agility and vertical jump performance in a rested and fatigued state.
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: BeetrootContaining 385 mg nitrate |
| Placebo beverage | Placebo comparator | Other: Placebo beverage<0.1 mmol nitrate in sucrose solution with beet coloring |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male and female participants in self-reported good general health as assessed by the standard procedures described below and specifically meeting normal blood pressure range (systolic: 100-135, diastolic: 60-90) and body mass index (BMI) range (16.0-29.9)
- Range of 18-45 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 (9 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 |
|---|---|---|
| BeetrootContaining 385 mg nitrate | Other | Test Beet shot |
| Placebo beverage<0.1 mmol nitrate in sucrose solution with beet coloring | Other | Placebo beverage |
Primary outcome
Linear running sprint time
Time frame: 5 days
Linear running sprint in a rested and fatigued state
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 21 Jun 2018.
- Individual participant dataSharing planned: No
Related trials for Exercise Performance
Not yet recruiting
Motor Imagery and Turning Practice to Improve Mobility: Pilot Trial
Mobility Impairment, Community Dwelling Older Adults
Not yet recruiting
A Comparison of the Effects of Exercise Methods for Adolescent Hyperkyphosis on the Sensorimotor System
Kyphosis Postural Thoracic, Kyphosis
Recruiting
Acute Effects of Post-Exercise Hyperoxia on Recovery in Cycling
Athletic Performance, Hyperbaric Oxygenation
Not yet recruiting
Effects of Virtual Reality Exergaming on Reaction Time, Physical Performance, and Muscle Activity in Children
Neuromuscular Performance, Reaction Time
Not yet recruiting
EFFECT OF ADDING BLOOD FLOW RESTRICTION TRAINING TO CLOSED CHAIN EXERCISE IN KNEE OSTEOARTHRITIS
Knee Osteoarthritis
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.
Andy Jones, PhD principal investigator
University of Exeter, Sport and Health Sciences department
Questions about this trial
What is this clinical trial studying?
A study testing Beetroot in people with Exercise Performance, run by PepsiCo Global R&D.
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 9 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 21 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Linear running sprint time (time frame: 5 days). 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 21 Jun 2018.