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OpenTrials
Completed

NCT Number: NCT03000582

Assessment of Different Forms of Creatine

The purpose of this study is to examine the pharmacokinetics of creatine nitrate supplementation.

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Key information

Study type

Interventional

Phase

Not applicable

About this study

Creatine nitrate contains several nutrients that may increase anaerobic exercise performance. Theoretically, dietary supplementation of creatine nitrate during resistance training can improve the quality of training leading to greater changes in strength, power and fat free mass. Endothelial function measured by flow-mediated dilation (FMD), a non-invasive vascular health parameter that can be measured via ultrasonography, is a predictor of cardiovascular disease risk which precedes traditional risk markers. Diet, physical activity and pharmaceutical interventions can all impact vascular function and health. The purpose of this study is to determine the acute vascular response of creatine nitrate supplementation on FMD by analyzing the pharmacokinetics of creatine nitrate supplementation.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • you are an apparently healthy and recreationally active male between the ages of 18 and 40;

Exclusion criteria

  • you have a history of treatment for metabolic disease (i.e., diabetes), hypertension, hypotension, thyroid disease, arrhythmia and/or cardiovascular disease;
  • you are currently using prescription medications;
  • you have a history of smoking;
  • you drink excessively (i.e., 12 drinks per week or more);
  • you have a recent history of creatine supplementation within six weeks of the start of supplementation;

Treatment and study plan

Creatine Monohydrate

Dietary Supplement

Creatine monohydrate (5.0 g creatine monohydrate, 1.5 g dextrose)

Creatine nitrate-1

Dietary Supplement

Creatine nitrate-1 (1.0 g creatine monohydrate, 0.5 g nitrate, 5.0 g dextrose)

Creatine nitrate-2

Dietary Supplement

Creatine nitrate-2 (2.0 g creatine monohydrate, 1.0 g nitrate, 3.5 g dextrose)

Placebo

Dietary Supplement

Placebo (6.5 g dextrose)

Primary outcomes

  1. Examine creatine vs. creatine nitrate supplementation by assessing body water

    Time frame: One day

  2. Examine creatine vs. creatine nitrate supplementation by assessing body composition

    Time frame: One day

  3. Examine creatine vs. creatine nitrate supplementation by assessing serum creatine levels

    Time frame: One day

  4. Examine creatine vs. creatine nitrate supplementation by assessing serum nitrate levels

    Time frame: One day

  5. Examine creatine vs. creatine nitrate supplementation by assessing serum nitrite levels

    Time frame: One day

  6. Examine creatine vs. creatine nitrate supplementation by assessing flow-mediated dilation (FMD) via ultrasonography

    Time frame: One day

Secondary outcomes

  1. Measure standard clinical chemistry panels in the blood to evaluate safety

    Time frame: One day

  2. Measure side effects to evaluate safety utilizing a side effects questionnaire

    Time frame: One day

  3. Measure heart rate to evaluate safety

    Time frame: One day

  4. Measure blood pressure to evaluate safety

    Time frame: One day

Sponsors and collaborators

Lead sponsor

Texas A&M University

Other

Collaborators

  • Nutrabolt

Registry information

Official study title

Pharmacokinetic Assessment of Acute Ingestion of Different Forms of Creatine

Acronym: NB3

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Dec 22, 2016
Registry last updated
Dec 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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