Nitrate Supplementation; Duration

NCT ID: NCT02115893

Last Updated: 2016-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Time-trial Performance Submaximal Exercise Performance Nitrite Nitrate

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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)

Group Type ACTIVE_COMPARATOR

Sodium Nitrate

Intervention Type DIETARY_SUPPLEMENT

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)

Group Type PLACEBO_COMPARATOR

Sodium Chloride

Intervention Type DIETARY_SUPPLEMENT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sodium Nitrate

Intervention Type DIETARY_SUPPLEMENT

Sodium Chloride

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lex B Verdijk, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Maastricht University Medical Centre+

Maastricht, Limburg, Netherlands

Site Status

Maastricht University Medical Centre+

Maastricht, Limburg, Netherlands

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Netherlands

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 23640589 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22248502 (View on PubMed)

Bescos 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.

Reference Type BACKGROUND
PMID: 22260513 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

METC13-3-059

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Beclomethasone in Healthy Athletes
NCT05352191 UNKNOWN PHASE4
Histamines and Central Hemodynamics
NCT07285031 RECRUITING NA
Methemoglobin Concentration in High Dose Inhaled Nitric Oxide
NCT05612074 ACTIVE_NOT_RECRUITING EARLY_PHASE1