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.

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

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• 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.

Contacts and Locations

Locations

United Kingdom

University of Exeter, Sport and Health Sciences department,

Exeter, United Kingdom

Sponsors and Collaborators

PepsiCo Global R&D

More Information

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

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