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Nitrate Supplementation; Duration (NO-how)

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ClinicalTrials.gov Identifier: NCT02115893
Recruitment Status : Completed
First Posted : April 16, 2014
Last Update Posted : March 16, 2016
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center

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

Condition or disease Intervention/treatment Phase
Time-trial Performance Submaximal Exercise Performance Nitrite Nitrate Dietary Supplement: Sodium Nitrate Dietary Supplement: Sodium Chloride Phase 4

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Official Title: The Effect of Nitrate Supplementation on Sports Performance: Duration of Supplementation
Study Start Date : April 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Sodium Nitrate
Dietary Supplement: Sodium nitrate 800 mg of nitrate in sodium nitrate added with water to get a 140 mL solution (BASF, Ludwigshafen, Germany)
Dietary Supplement: Sodium Nitrate
Placebo Comparator: Sodium Cloride
Dietary Supplement: Sodium chloride 800 mg of sodium chloride added with water to get a 140 mL solution (Frisia Zout BV, Harlingen, The Netherlands)
Dietary Supplement: Sodium Chloride



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



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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:

  • 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

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): NCT02115893


Locations
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Netherlands
Maastricht University Medical Centre+
Maastricht, Limburg, Netherlands, 6200 MD
Maastricht University Medical Centre+
Maastricht, Limburg, Netherlands, 6200MD
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
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Principal Investigator: Lex B Verdijk, PhD Maastricht University