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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02436629
Other study ID # METC 153006
Secondary ID
Status Completed
Phase Phase 4
First received May 4, 2015
Last updated July 5, 2016
Start date May 2015
Est. completion date July 2016

Study information

Verified date March 2016
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 objective of the current study is to assess the effect of 6-day dietary nitrate ingestion on high intensity intermittent sports performance in recreational soccer players.


Description:

Oral ingestion of nitrate (NO3-) in the form of both nitrate salts and concentrated red beetroot juice has been shown to significantly lower blood pressure at rest and to improve exercise performance during cycle time trials. Furthermore, a positive exercise performance effect of nitrate ingestion has been observed in recreational athletes during intermittent exercise. However, this was achieved after acute supplementation with a substantial dose of dietary nitrate. Whether similar ergogenic effects of nitrate supplementation can be achieved with a more conventional 6-day nitrate supplementation protocol with a lower daily dose remains to be established. Based on the gaps in current literature, our main goal will be to gain further insight into the effects of a 6-day nitrate supplementation protocol on high intensity intermittent exercise performance in recreational athletes.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date July 2016
Est. primary completion date April 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- Healthy P

- Players of the first two senior selection teams of a regional soccer club competing at the 3rd KNVB level or higher

- Training =2 days a week

- 18-40 years

- Male

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, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science


Related Conditions & MeSH terms

  • High Intensity Intermittent Sports Performance

Intervention

Dietary Supplement:
Nitrate-rich concentrated beetroot juice
James White, Beet It Sport Shot, 70ml (Standard)
Nitrate-depleted concentrated red beetroot juice
Beet It Sport Shot, 70ml (Placebo)

Locations

Country Name City State
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 (4)

Bangsbo J, Iaia FM, Krustrup P. The Yo-Yo intermittent recovery test : a useful tool for evaluation of physical performance in intermittent sports. Sports Med. 2008;38(1):37-51. Review. — View Citation

Bond H, Morton L, Braakhuis AJ. Dietary nitrate supplementation improves rowing performance in well-trained rowers. Int J Sport Nutr Exerc Metab. 2012 Aug;22(4):251-6. Epub 2012 Jun 15. — 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, Mohr M, Krustrup P, Jackman SR, Erm?dis G, Kelly J, Black MI, Bailey SJ, Vanhatalo A, Jones AM. Dietary nitrate supplementation improves team sport-specific intense intermittent exercise performance. Eur J Appl Physiol. 2013 Jul;113(7):1673-84. doi: 10.1007/s00421-013-2589-8. Epub 2013 Feb 1. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Baseline characteristics Height, body weight, age, BMI 30 min during visit 1 (Screening) No
Primary Total distance covered during the Yo-Yo Intermittent Recovery 1 test (Yo-Yo IR1 test) Performance 3 hours post red beetroot juice ingestion No
Secondary Plasma concentration of nitrite and nitrate Concetrations 3 hours post red beetroot juice ingestion No
Secondary Salivary concentration of nitrite and nitrate Concetrations 3 hours post red beetroot juice ingestion No