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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02162927
Other study ID # HSC2014
Secondary ID
Status Completed
Phase N/A
First received June 9, 2014
Last updated March 2, 2015
Start date August 2014
Est. completion date November 2014

Study information

Verified date March 2015
Source Florida State University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Description:

The purpose of this randomized, double-blind, crossover study is to identify if dietary nitrate supplementation improves strength , endurance, and power measurements in male CrossFit athletes. Specifically, the strength measurements will be taken using isometric and isokinetic tests on the Biodex dynamometer. Endurance will be measured using time trials for a 2000 meter rowing test and the "Fran" CrossFit workout. Finally, power will be analyzed using the Wingate cycle test.

The treatment group will receive 1 serving of f potassium nitrate KNO3- (N) (8 mmols NO3-). The placebo group will receive 1 serving of the nitrate-free placebo (PL) potassium chloride (8 mmol KCl).

The participants will complete two three-day baseline testing, with a six-day supplementation period following each round of baseline testing. Following the first six-day supplementation period, there will be a 10 day washout period before the second baseline testing begins.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date November 2014
Est. primary completion date October 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 35 Years
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States CrossFit Blackbox Tallahassee Florida
United States Florida State University Tallahassee Florida

Sponsors (1)

Lead Sponsor Collaborator
Florida State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Muscular Strength Muscular Strength will be tested using the isometric and isokinetic strength tests. During 1 month of study No
Primary Muscular Endurance Endurance will be tested using the 2000 meter rowing ergometer test and CrossFit circuit known as "Fran". 1 month No
Primary Muscular Power Power will be measured using the Wingate cycle test. 1 month No
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