Clinical trial NCT03000582: Assessment of Different Forms of Creatine
Official title: Pharmacokinetic Assessment of Acute Ingestion of Different Forms of Creatine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Modification
Lead sponsor: Texas A&M University
Sponsor class: OTHER
Collaborators: name: Nutrabolt
First posted: 2016-12-22
Enrollment: 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

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

Detailed description: 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.

Eligibility criteria: 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;

Primary outcomes:
measure: Examine creatine vs. creatine nitrate supplementation by assessing body water
timeFrame: One day
measure: Examine creatine vs. creatine nitrate supplementation by assessing body composition
timeFrame: One day
measure: Examine creatine vs. creatine nitrate supplementation by assessing serum creatine levels
timeFrame: One day
measure: Examine creatine vs. creatine nitrate supplementation by assessing serum nitrate levels
timeFrame: One day
measure: Examine creatine vs. creatine nitrate supplementation by assessing serum nitrite levels
timeFrame: One day
measure: Examine creatine vs. creatine nitrate supplementation by assessing flow-mediated dilation (FMD) via ultrasonography
timeFrame: One day
Secondary outcomes:
measure: Measure standard clinical chemistry panels in the blood to evaluate safety
timeFrame: One day
measure: Measure side effects to evaluate safety utilizing a side effects questionnaire
timeFrame: One day
measure: Measure heart rate to evaluate safety
timeFrame: One day
measure: Measure blood pressure to evaluate safety
timeFrame: One day
Other outcomes:
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