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CompletedNCT03616093Updated Aug 6, 2018

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.

An interventional study of Test Beet Shot and Placebo Beverage in Exercise Performance, sponsored by PepsiCo Global R&D. Completed at 1 site in United Kingdom. Open to male participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-06.

Sponsored by PepsiCo Global R&D · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Sep 2017, registered Jun 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
Male
01

Study 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. 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.

02

Conditions studied

  • Exercise Performance
03

In context

Lead sponsor

PepsiCo Global R&D is the lead sponsor of 101 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  1. 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.
  2. 18-35 years of age
  3. 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).
  4. Understanding of the procedures to be undertaken as part of the study
  5. Willingness to participate in exercise testing and follow supplementation guidelines and other instructions provided by the experimenter
  6. Informed, voluntary, written consent to participate in the study

Exclusion criteria

Exclusion Criteria:

  1. Known pulmonary, cardiovascular or metabolic disease
  2. Food allergies including phenylketonurea (PKU)
  3. 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.
  4. Blood donation within 3 months prior to the start of the study
  5. Substance abuse within 2 years of the start of the study
  6. Smoking
  7. Any prescription and non-prescription medication which may impact saliva production (antidepressants, diuretics, analgesics, antihistamines, anti-hyper/hypo-tensives, anti-anxiety, appetite suppressants).
  8. Current or previous use of phosphodiesterase 5 (PDE5) inhibitors.
  9. Participation in another clinical trial within past 4 weeks and/or participation in a PepsiCo trial within the last 6 months.
  10. Chronic use (6 months) of any antibacterial mouthwash products.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    Test Beet shot

    Active supplement containing 6.2 mmol nitrate

    Other: Test Beet Shot

  • Placebo comparator
    Placebo beverage

    Placebo supplement containing negligible nitrate

    Other: Placebo Beverage

Interventions

  • OtherTest Beet Shot

    Active supplement containing 6.2 mmol nitrate

  • OtherPlacebo Beverage

    Placebo supplement containing negligible nitrate

06

What researchers measure

Primary outcomes

  1. Distance covered during high-intensity intermittent exercise performance

    Time frame: 4 days

  2. Distance covered during high-intensity intermittent exercise performance

    Time frame: 2 hours

Secondary outcomes

  1. Plasma nitrate concentrations

    Time frame: 4 days

  2. Nitrite concentrations

    Time frame: 2 hours

07

Study locations

1 site
  • University of Exeter, Sport and Health Sciences department,
    Exeter, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 6, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03616093
Lead sponsor
PepsiCo Global R&D
Responsible party
Sponsor
First posted
Aug 6, 2018
Start date
Sep 30, 2017
Primary completion
May 1, 2018
Completion
May 31, 2018
Last update
Aug 6, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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