NCT01384968

Brief Summary

Six days of dietary nitrate (NO3-) supplementation in the form of beetroot juice (\~0.5 L•d-1; 5.1-11.2 mmol NO3- •d-1) has been purported to reduce pulmonary oxygen uptake (VO2) during submaximal exercise and increase tolerance to high-intensity workloads. These results suggest that dietary nitrate supplementation has the potential to act as an ergogenic aid. Recently, we assessed submaximal oxygen uptake and 10 km time trial performance after 6 d of dietary nitrate supplementation in trained cyclists. We demonstrated an improvement in time trial performance compared to the nitrate-depleted placebo. However, the minimal dosage and duration of nitrate supplementation that is needed to elicit these performance effects remain largely unknown. Therefore, the purpose of the study is to assess performance capacity following an acute dose of nitrate supplementation consumed 3 h prior to the onset of exercise in trained cyclists. We will test the hypothesis that a single dose (140 mL; \~8 mmol NO3-) of dietary nitrate supplementation in the form of beetroot juice, ingested 3 h prior to exercise will improve time trial performance in trained cyclists compared to a nitrate-depleted placebo.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 29, 2011

Completed
2 days until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

October 17, 2012

Status Verified

October 1, 2012

Enrollment Period

6 months

First QC Date

June 23, 2011

Last Update Submit

October 16, 2012

Conditions

Keywords

nitriteexercisecycling

Outcome Measures

Primary Outcomes (1)

  • Time-trial performance

    Subjects will be asked to visit the laboratory for a total of 4 visits over 4 weeks. During visits 2,3 and 4 time-trial performance will be assessed. Each visit will be separated on average by at least 1 week. Therefore, if subjects have their first visit (max text) in week 1, their time trial performance will be assessed during weeks 2, 3 and 4.

    Laboratory visits 2, 3 and 4 (each visit separated by ~ 1wk))

Secondary Outcomes (2)

  • Nitrate and nitrite plasma concentration

    Laboratory visits 3 and 4 (approximately 1 wk apart)

  • blood metabolites (glucose, insulin, lactate, free fatty acids)

    Laboratory visits 3 and 4 (approximately 1 wk apart)

Study Arms (2)

Beetroot juice

EXPERIMENTAL

beetroot juice (170 mL, 8 mmol nitrate)

Dietary Supplement: beetroot juice

Nitrate-depleted beetroot juice

PLACEBO COMPARATOR

140 mL ...0 nitrate. Beetroot juice

Dietary Supplement: beetroot juice

Interventions

beetroot juiceDIETARY_SUPPLEMENT

170 mL beetroot juice (Beet It, James White drinks Ltd).

Also known as: Beet It, James White Drinks Ltd.
Beetroot juiceNitrate-depleted beetroot juice

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy
  • Male
  • years of age
  • Endurance cycling trained (≥3 sessions of endurance exercise per week)
  • VO2 max ≥ 50 ml/kg/min
  • Training history of more than one year of ≥3 sessions of endurance cycling exercise per week
  • BMI \<25 kg/m2

You may not qualify if:

  • Use of medication
  • Smoking
  • Currently supplementing diet with beetroot juice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University

Maastricht, Limburg, 6229ER, Netherlands

Location

Related Publications (21)

  • Vanhatalo A, Bailey SJ, Blackwell JR, DiMenna FJ, Pavey TG, Wilkerson DP, Benjamin N, Winyard PG, Jones AM. Acute and chronic effects of dietary nitrate supplementation on blood pressure and the physiological responses to moderate-intensity and incremental exercise. Am J Physiol Regul Integr Comp Physiol. 2010 Oct;299(4):R1121-31. doi: 10.1152/ajpregu.00206.2010. Epub 2010 Aug 11.

    PMID: 20702806BACKGROUND
  • Bailey SJ, Winyard P, Vanhatalo A, Blackwell JR, Dimenna FJ, Wilkerson DP, Tarr J, Benjamin N, Jones AM. Dietary nitrate supplementation reduces the O2 cost of low-intensity exercise and enhances tolerance to high-intensity exercise in humans. J Appl Physiol (1985). 2009 Oct;107(4):1144-55. doi: 10.1152/japplphysiol.00722.2009. Epub 2009 Aug 6.

    PMID: 19661447BACKGROUND
  • Lansley KE, Winyard PG, Fulford J, Vanhatalo A, Bailey SJ, Blackwell JR, DiMenna FJ, Gilchrist M, Benjamin N, Jones AM. Dietary nitrate supplementation reduces the O2 cost of walking and running: a placebo-controlled study. J Appl Physiol (1985). 2011 Mar;110(3):591-600. doi: 10.1152/japplphysiol.01070.2010. Epub 2010 Nov 11.

    PMID: 21071588BACKGROUND
  • Kenjale AA, Ham KL, Stabler T, Robbins JL, Johnson JL, Vanbruggen M, Privette G, Yim E, Kraus WE, Allen JD. Dietary nitrate supplementation enhances exercise performance in peripheral arterial disease. J Appl Physiol (1985). 2011 Jun;110(6):1582-91. doi: 10.1152/japplphysiol.00071.2011. Epub 2011 Mar 31.

    PMID: 21454745BACKGROUND
  • Bailey SJ, Fulford J, Vanhatalo A, Winyard PG, Blackwell JR, DiMenna FJ, Wilkerson DP, Benjamin N, Jones AM. Dietary nitrate supplementation enhances muscle contractile efficiency during knee-extensor exercise in humans. J Appl Physiol (1985). 2010 Jul;109(1):135-48. doi: 10.1152/japplphysiol.00046.2010. Epub 2010 May 13.

    PMID: 20466802BACKGROUND
  • Beelen M, Berghuis J, Bonaparte B, Ballak SB, Jeukendrup AE, van Loon LJ. Carbohydrate mouth rinsing in the fed state: lack of enhancement of time-trial performance. Int J Sport Nutr Exerc Metab. 2009 Aug;19(4):400-9. doi: 10.1123/ijsnem.19.4.400.

    PMID: 19827464BACKGROUND
  • 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. doi: 10.1123/ijsnem.22.1.64.

    PMID: 22248502BACKGROUND
  • Currell K, Jeukendrup AE. Validity, reliability and sensitivity of measures of sporting performance. Sports Med. 2008;38(4):297-316. doi: 10.2165/00007256-200838040-00003.

    PMID: 18348590BACKGROUND
  • Dejam A, Hunter CJ, Schechter AN, Gladwin MT. Emerging role of nitrite in human biology. Blood Cells Mol Dis. 2004 May-Jun;32(3):423-9. doi: 10.1016/j.bcmd.2004.02.002.

    PMID: 15121102BACKGROUND
  • Duncan C, Dougall H, Johnston P, Green S, Brogan R, Leifert C, Smith L, Golden M, Benjamin N. Chemical generation of nitric oxide in the mouth from the enterosalivary circulation of dietary nitrate. Nat Med. 1995 Jun;1(6):546-51. doi: 10.1038/nm0695-546.

    PMID: 7585121BACKGROUND
  • Jeukendrup A, Saris WH, Brouns F, Kester AD. A new validated endurance performance test. Med Sci Sports Exerc. 1996 Feb;28(2):266-70. doi: 10.1097/00005768-199602000-00017.

    PMID: 8775164BACKGROUND
  • Larsen FJ, Weitzberg E, Lundberg JO, Ekblom B. Effects of dietary nitrate on oxygen cost during exercise. Acta Physiol (Oxf). 2007 Sep;191(1):59-66. doi: 10.1111/j.1748-1716.2007.01713.x. Epub 2007 Jul 17.

    PMID: 17635415BACKGROUND
  • Larsen FJ, Weitzberg E, Lundberg JO, Ekblom B. Dietary nitrate reduces maximal oxygen consumption while maintaining work performance in maximal exercise. Free Radic Biol Med. 2010 Jan 15;48(2):342-7. doi: 10.1016/j.freeradbiomed.2009.11.006. Epub 2009 Nov 12.

    PMID: 19913611BACKGROUND
  • Laursen PB, Shing CM, Jenkins DG. Reproducibility of a laboratory-based 40-km cycle time-trial on a stationary wind-trainer in highly trained cyclists. Int J Sports Med. 2003 Oct;24(7):481-5. doi: 10.1055/s-2003-42012.

    PMID: 12968204BACKGROUND
  • Lundberg JO, Weitzberg E, Gladwin MT. The nitrate-nitrite-nitric oxide pathway in physiology and therapeutics. Nat Rev Drug Discov. 2008 Feb;7(2):156-67. doi: 10.1038/nrd2466.

    PMID: 18167491BACKGROUND
  • Palmer GS, Dennis SC, Noakes TD, Hawley JA. Assessment of the reproducibility of performance testing on an air-braked cycle ergometer. Int J Sports Med. 1996 May;17(4):293-8. doi: 10.1055/s-2007-972849.

    PMID: 8814512BACKGROUND
  • Smith MF, Davison RC, Balmer J, Bird SR. Reliability of mean power recorded during indoor and outdoor self-paced 40 km cycling time-trials. Int J Sports Med. 2001 May;22(4):270-4. doi: 10.1055/s-2001-13813.

    PMID: 11414669BACKGROUND
  • van Dijk JW, Manders RJ, Hartgens F, Stehouwer CD, Praet SF, van Loon LJ. Postprandial hyperglycemia is highly prevalent throughout the day in type 2 diabetes patients. Diabetes Res Clin Pract. 2011 Jul;93(1):31-7. doi: 10.1016/j.diabres.2011.03.021. Epub 2011 Apr 16.

    PMID: 21497935BACKGROUND
  • Webb AJ, Patel N, Loukogeorgakis S, Okorie M, Aboud Z, Misra S, Rashid R, Miall P, Deanfield J, Benjamin N, MacAllister R, Hobbs AJ, Ahluwalia A. Acute blood pressure lowering, vasoprotective, and antiplatelet properties of dietary nitrate via bioconversion to nitrite. Hypertension. 2008 Mar;51(3):784-90. doi: 10.1161/HYPERTENSIONAHA.107.103523. Epub 2008 Feb 4.

    PMID: 18250365BACKGROUND
  • Zand J, Lanza F, Garg HK, Bryan NS. All-natural nitrite and nitrate containing dietary supplement promotes nitric oxide production and reduces triglycerides in humans. Nutr Res. 2011 Apr;31(4):262-9. doi: 10.1016/j.nutres.2011.03.008.

    PMID: 21530799BACKGROUND
  • Zhang Z, Naughton D, Winyard PG, Benjamin N, Blake DR, Symons MC. Generation of nitric oxide by a nitrite reductase activity of xanthine oxidase: a potential pathway for nitric oxide formation in the absence of nitric oxide synthase activity. Biochem Biophys Res Commun. 1998 Aug 28;249(3):767-72. doi: 10.1006/bbrc.1998.9226.

    PMID: 9731211BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Luc van Loon, Ph.D.

    Maastricht University

    STUDY DIRECTOR
  • Naomi Cermak, Ph.D.

    Maastricht University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2011

First Posted

June 29, 2011

Study Start

July 1, 2011

Primary Completion

January 1, 2012

Study Completion

May 1, 2012

Last Updated

October 17, 2012

Record last verified: 2012-10

Locations