NCT03616093

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 30, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2018

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

June 6, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 6, 2018

Completed
Last Updated

August 6, 2018

Status Verified

August 1, 2018

Enrollment Period

7 months

First QC Date

June 6, 2018

Last Update Submit

August 2, 2018

Conditions

Outcome Measures

Primary Outcomes (2)

  • Distance covered during high-intensity intermittent exercise performance

    4 days

  • Distance covered during high-intensity intermittent exercise performance

    2 hours

Secondary Outcomes (2)

  • Plasma nitrate concentrations

    4 days

  • Nitrite concentrations

    2 hours

Study Arms (2)

Test Beet shot

EXPERIMENTAL

Active supplement containing 6.2 mmol nitrate

Other: Test Beet Shot

Placebo beverage

PLACEBO COMPARATOR

Placebo supplement containing negligible nitrate

Other: Placebo Beverage

Interventions

Active supplement containing 6.2 mmol nitrate

Test Beet shot

Placebo supplement containing negligible nitrate

Placebo beverage

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.
  • 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

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Exeter, Sport and Health Sciences department,

Exeter, United Kingdom

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2018

First Posted

August 6, 2018

Study Start

September 30, 2017

Primary Completion

May 1, 2018

Study Completion

May 31, 2018

Last Updated

August 6, 2018

Record last verified: 2018-08

Locations