Nitrate Supplementation; Duration

Nitrate Clinical Trial

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Official title:

The Effect of Nitrate Supplementation on Sports Performance: Duration of Supplementation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02115893
• Other study ID #: METC13-3-059
• Status: Completed
• Phase: Phase 4
• First received: April 10, 2014
• Last updated: March 15, 2016
• Start date: April 2014
• Est. completion date: March 2015

Study information

• Verified date: October 2014
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

The main aim of the current study will be to find the optimal duration of supplementation to enhance sports performance.

Description:

Oral ingestion of nitrate (NO3-) in the form of both nitrate salts and beetroot juice has been shown to significantly lower blood pressure at rest and to also lower pulmonary oxygen uptake during exercise, in addition to improving exercise performance during cycle time trial. However, there has been no consensus on the optimal supplementation protocols, in terms of duration of supplementation to see these metabolic effects. Furthermore, a positive exercise performance effect of nitrate ingestion has primarily been observed in recreational athletes. The potentially ergogenic effects of nitrate in well-trained or elite athletes therefore remain to be fully established. Based on the gaps in current literature, our main goal will be to gain further insight into different aspects of nitrate supplementation to enhance (elite) sports performance. This will be investigated in this study by assessing the effect of an acute vs. chronic supplementation period of sodium nitrate (NaNO3-) on exercise performance.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• 18.5 < BMI < 25 kg/m2

• Endurance trained cyclists/triathletes (with at least 1 year of competitive cycling experience)

• VO2max = 55 mL/kg/min

Exclusion Criteria:

• Use of medication

• Injury prohibiting them from performing the exercise protocol effectively

• Smoking

• Currently supplementing diet with nitrate

• Lactose intolerance

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Nitrate
• Nitrite
• Submaximal Exercise Performance
• Time-trial Performance

Intervention

Dietary Supplement:
• Sodium Nitrate

• Sodium Chloride

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Centre+	Maastricht	Limburg
Netherlands	Maastricht University Medical Centre+	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (3)

Bescós R, Sureda A, Tur JA, Pons A. The effect of nitric-oxide-related supplements on human performance. Sports Med. 2012 Feb 1;42(2):99-117. doi: 10.2165/11596860-000000000-00000. Review. — View Citation

Cermak NM, Gibala MJ, van Loon LJ. Nitrate supplementation's improvement of 10-km time-trial performance in trained cyclists. Int J Sport Nutr Exerc Metab. 2012 Feb;22(1):64-71. — View Citation

Wylie LJ, Kelly J, Bailey SJ, Blackwell JR, Skiba PF, Winyard PG, Jeukendrup AE, Vanhatalo A, Jones AM. Beetroot juice and exercise: pharmacodynamic and dose-response relationships. J Appl Physiol (1985). 2013 Aug 1;115(3):325-36. doi: 10.1152/japplphysiol.00372.2013. Epub 2013 May 2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Baseline characteristics and fitness level assessment	Resting blood pressure, height, body weight, age, BMI, measures of GI tolerance, VO2 max, Wmax, rate of perceived exertion	3 hours during visit 1 (Screening)	No
Primary	Time-trial exercise performance	The primary outcome measure will be the time to complete the time-trial following dietary nitrate or placebo ingestion	Time trial starts 4 hours after ingestion and ends on average after 15 minutes of cycling (depending on subject's cycling speed)	No
Secondary	Resting blood pressure	Resting blood pressure measures following ingestion of dietary nitrate	30 min pre-ingestion until 2.5 hours post-ingestion	No
Secondary	Plasma nitrate and nitrite levels	Plasma nitrate and nitrite levels following ingestion of dietary nitrate	30 min pre-ingestion until 30 min post-time-trial testing	No
Secondary	Submaximal exercise performance	Oxygen consumption CO2 production and heart rate during submaximal exercise	starting from 3 hours post-ingestion on testing days until completion of the submaximal exercise	No
Secondary	Time-trial exercise performance; power output and heart rate	Power output and heart rate during the time-trial exercise	starting from 4 hours post-ingestion on testing days until completion of the time-trial	No