NCT02162927

Brief Summary

In the past, dietary nitrate supplementation has been shown to have clinical benefits in the treatment of cardiovascular issues. More recently, however, the focus of nitrate supplementation has shifted to focus of human performance, and has shown to increase the time to exhaustion during maximal intensity exercise and lower the cost of oxygen consumption during submaximal intensity exercise. Acutely, nitrate supplementation in the form of beetroot juice has been shown to increase strength measurements, as well as increase the time to complete a 2000 meter rowing ergometer test. However, to the author's knowledge, there are no studies that link the relationship between multi-day nitrate supplementation and the rowing test or the nitrate's effect on strength when in the salt form. Additionally, to the author's knowledge, no evidence has been published which relates dietary nitrate supplementation and its effects on a CrossFit circuit workout. Our central hypothesis is that six days of dietary nitrate supplementation will improve strength, endurance, a power more than a placebo in male CrossFit athletes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 13, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

March 4, 2015

Status Verified

March 1, 2015

Enrollment Period

2 months

First QC Date

June 9, 2014

Last Update Submit

March 2, 2015

Conditions

Performance

Keywords

muscular strengthmuscular endurancemuscular powerrowingCrossFitdietary nitrate

Outcome Measures

Primary Outcomes (3)

  • Muscular Strength

    Muscular Strength will be tested using the isometric and isokinetic strength tests.

    During 1 month of study

  • Muscular Endurance

    Endurance will be tested using the 2000 meter rowing ergometer test and CrossFit circuit known as "Fran".

    1 month

  • Muscular Power

    Power will be measured using the Wingate cycle test.

    1 month

Study Arms (2)

Potassium Nitrate (N)

EXPERIMENTAL

This involves 1 serving (2 pills) of potassium nitrate KNO3- (N) (8 mmols NO3-). The supplementation period is six days. This pill must be taken on an empty stomach (2-3 hours after eating) and must be taken about 2-3 hours before exercise.

Dietary Supplement: Dietary Nitrate

Potassium Chloride

PLACEBO COMPARATOR

This involves 1 serving (2 pills) of the nitrate-free placebo (PL) potassium chloride (8 mmol KCl) for a six-day supplementation period. This pill must be taken on an empty stomach (2-3 hours after eating) and must be taken about 2-3 hours before exercise.

Dietary Supplement: Potassium Chloride (placebo)

Interventions

Dietary NitrateDIETARY_SUPPLEMENT

This pill must be taken on an empty stomach (2-3 hours after eating) and must be taken about 2-3 hours before exercise.

Potassium Nitrate (N)
Potassium Chloride (placebo)DIETARY_SUPPLEMENT

This pill must be taken on an empty stomach (2-3 hours after eating) and must be taken about 2-3 hours before exercise.

Potassium Chloride

Eligibility Criteria

Age20 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • College-aged male CrossFit between the ages of 20 and 35 years (yr), a peak maximum oxygen uptake (VO2peak) of at least 50 ml/kg/min will be recruited to participate in this study.

You may not qualify if:

  • Having any thyroid and/or kidney diseases that could affect NO synthesis and/or metabolism, any illness, smoking, taking other medications, injured, not well-trained (as noted by the VO2peak), consuming any other supplements at the time of the study except protein or multivitamin, allergic to any component of the supplement, including tree nuts, in case of potential packaging mixing and contamination. Women and children as well are excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CrossFit Blackbox

Tallahassee, Florida, 32301, United States

Location

Florida State University

Tallahassee, Florida, United States

Location

MeSH Terms

Interventions

Potassium Chloride

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsPotassium Compounds

Study Officials

  • Michael Ormsbee, PhD

    Florida State University

    PRINCIPAL INVESTIGATOR

  • Samuel J Kramer, BS

    Florida State University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 9, 2014

First Posted

June 13, 2014

Study Start

August 1, 2014

Primary Completion

October 1, 2014

Study Completion

November 1, 2014

Last Updated

March 4, 2015

Record last verified: 2015-03

Locations

US(2)