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Completed

NCT Number: NCT02115893

Nitrate Supplementation; Duration

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

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Key information

Conditions

Time-trial Performance Nitrate Nitrite Submaximal Exercise Performance

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Maastricht University Medical Centre+, Maastricht, Limburg, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sodium nitrate

Dietary Supplement

Sodium chloride

Dietary Supplement

Primary outcomes

  1. Time-trial exercise performance

    Time frame: Time trial starts 4 hours after ingestion and ends on average after 15 minutes of cycling (depending on subject's cycling speed)

    The primary outcome measure will be the time to complete the time-trial following dietary nitrate or placebo ingestion

Secondary outcomes

  1. Resting blood pressure

    Time frame: 30 min pre-ingestion until 2.5 hours post-ingestion

    Resting blood pressure measures following ingestion of dietary nitrate

  2. Plasma nitrate and nitrite levels

    Time frame: 30 min pre-ingestion until 30 min post-time-trial testing

    Plasma nitrate and nitrite levels following ingestion of dietary nitrate

  3. Submaximal exercise performance

    Time frame: starting from 3 hours post-ingestion on testing days until completion of the submaximal exercise

    Oxygen consumption CO2 production and heart rate during submaximal exercise

  4. Time-trial exercise performance; power output and heart rate

    Time frame: starting from 4 hours post-ingestion on testing days until completion of the time-trial

    Power output and heart rate during the time-trial exercise

Other outcomes

  1. Baseline characteristics and fitness level assessment

    Time frame: 3 hours during visit 1 (Screening)

    Resting blood pressure, height, body weight, age, BMI, measures of GI tolerance, VO2 max, Wmax, rate of perceived exertion

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

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

Acronym: NO-how

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Apr 16, 2014
Registry last updated
Mar 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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