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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.

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ClinicalTrials.gov Identifier: NCT03616093
Recruitment Status : Completed
First Posted : August 6, 2018
Last Update Posted : August 6, 2018
Sponsor:
Information provided by (Responsible Party):
PepsiCo Global R&D

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.


Condition or disease Intervention/treatment Phase
Exercise Performance Other: Test Beet Shot Other: Placebo Beverage Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
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.
Actual Study Start Date : September 30, 2017
Actual Primary Completion Date : May 1, 2018
Actual Study Completion Date : May 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Test Beet shot
Active supplement containing 6.2 mmol nitrate
Other: Test Beet Shot
Active supplement containing 6.2 mmol nitrate

Placebo Comparator: Placebo beverage
Placebo supplement containing negligible nitrate
Other: Placebo Beverage
Placebo supplement containing negligible nitrate




Primary Outcome Measures :
  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 Outcome Measures :
  1. Plasma nitrate concentrations [ Time Frame: 4 days ]
  2. Nitrite concentrations [ Time Frame: 2 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03616093


Locations
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United Kingdom
University of Exeter, Sport and Health Sciences department,
Exeter, United Kingdom
Sponsors and Collaborators
PepsiCo Global R&D

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Responsible Party: PepsiCo Global R&D
ClinicalTrials.gov Identifier: NCT03616093     History of Changes
Other Study ID Numbers: PEP-1718
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: August 6, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No