Exercise PerformanceNCT03686982
The Impact of Supplementation With Novel Prototype Nutrition Bar on Nitric Oxide Bioavailability and Measures of Athlete Performance
A study testing Active Nitrate Bar in people with Exercise Performance, run by PepsiCo Global R&D at 1 site in United Kingdom.
Trial summary
Dietary nitrate, L-citrulline, epicatechin, vitamin C and glutathione have the potential to improve nitric oxide (NO) bioavailability, in humans, by influencing both the nitrate-nitrite-NO and NO synthase-dependent pathways, and the storage of NO. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise Performance
- What is being tested?
- Active Nitrate Bar
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2017to 30 Apr 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 40 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 the following blood pressure (BP) and body mass index (BMI) ranges: systolic BP: 100-140 mmHg; diastolic BP: 60-90 mmHg; and BMI 18.5-30.
- 18-40 years of age
- Physically active. Determined by meeting the following criteria: completes vigorous physical activity (i.e. activities that take hard physical effort and make you breathe much harder than normal; e.g. heavy lifting, digging, aerobics, fast cycling, running etc) at least 2 x per week and moderate physical activities (i.e. activities that take moderate physical effort and make you breath somewhat harder than normal; for example: carrying light loads, cycling at a regular pace, playing doubles tennis) at least 3 x per week.
- 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 12Show 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.
- Participation in another PepsiCo study within the past 6 months.
- Highly trained or elite endurance athlete as determined by current or recent (within 3 months) participation in an endurance sport at international or national level.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Exeter, Sport and Health Sciences department,
Exeter
About this study
Dietary nitrate, L-citrulline, epicatechin, vitamin C and glutathione have the potential to improve nitric oxide (NO) bioavailability, in humans, by influencing both the nitrate-nitrite-NO and NO synthase-dependent pathways, and the storage of NO. The study is designed to assess the efficacy of a newly developed product containing a mixture of these compounds. Specifically, the study will assess if the product is capable of increasing NO bioavailability and if this results in positive effects on exercise economy and intermittent exercise performance. These outcome measures have been chosen because they have previously been positively impacted by an increase in NO bioavailability.
- Conditions
- Exercise Performance
- Being tested
- Active Nitrate Bar, Placebo Bar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Nitrate BarOther
Bar containing Nitrate, L-citrulline; epicatechin; vitamin C and glutathione
Placebo BarOther
No active ingredients
| Study group | Role | What they receive |
|---|---|---|
| Active Nitrate Bar | Experimental | include dietary nitrate; L-citrulline; epicatechin; vitamin C and glutathione Receives: Other: Active Nitrate Bar |
| Placebo Bar | Placebo comparator | Containing no active ingredients Receives: Other: Placebo Bar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean power output during intermittent exercise test
Measured: 5 days of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2018
- Study start1 May 2017
- Primary completion15 Apr 2018
- Study completion30 Apr 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
- 24 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
- NCT03686982
- Sponsor's protocol ID
- PEP-1706
- Status last verified
- Sep 2018
- First submitted
- 6 Jun 2018
- Last updated
- 27 Sep 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 27 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Supplementation With Novel Prototype Nutrition Bar on Nitric Oxide Bioavailability and Measures of Athlete Performance
- ClinicalTrials.gov ID
- NCT03686982
- Acronym / sponsor ID
- PEP-1706
- Conditions
- Exercise Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Study start
- 1 May 2017 (actual)
- Primary completion
- 15 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 27 Sep 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, L-citrulline, epicatechin, vitamin C and glutathione have the potential to improve nitric oxide (NO) bioavailability, in humans, by influencing both the nitrate-nitrite-NO and NO synthase-dependent pathways, and the storage of NO. The study is designed to assess the efficacy of a newly developed product containing a mixture of these compounds. Specifically, the study will assess if the product is capable of increasing NO bioavailability and if this results in positive effects on exercise economy and intermittent exercise performance. These outcome measures have been chosen because they have previously been positively impacted by an increase in NO bioavailability.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Nitrate Bar | Experimental | Other: Active Nitrate Barinclude dietary nitrate; L-citrulline; epicatechin; vitamin C and glutathione |
| Placebo Bar | Placebo comparator | Other: Placebo BarContaining no active ingredients |
Who may qualify
- Ages
- 18 to 40 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 the following blood pressure (BP) and body mass index (BMI) ranges: systolic BP: 100-140 mmHg; diastolic BP: 60-90 mmHg; and BMI 18.5-30.
- 18-40 years of age
- Physically active. Determined by meeting the following criteria: completes vigorous physical activity (i.e. activities that take hard physical effort and make you breathe much harder than normal; e.g. heavy lifting, digging, aerobics, fast cycling, running etc) at least 2 x per week and moderate physical activities (i.e. activities that take moderate physical effort and make you breath somewhat harder than normal; for example: carrying light loads, cycling at a regular pace, playing doubles tennis) at least 3 x per week.
- 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 (12 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 |
|---|---|---|
| Active Nitrate BarBar containing Nitrate, L-citrulline; epicatechin; vitamin C and glutathione | Other | Active Nitrate Bar |
| Placebo BarNo active ingredients | Other | Placebo Bar |
Primary outcome
Mean power output during intermittent exercise test
Time frame: 5 days of intervention
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 27 Sep 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.
Andy Jones, PhD principal investigator
University of Exeter, Sport and Health Sciences department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Nitrate Bar 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 12 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 27 Sep 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?
Mean power output during intermittent exercise test (time frame: 5 days of intervention). 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 27 Sep 2018.