Assessment of Different Forms of Creatine

Study Overview
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Brief Summary
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The purpose of this study is to examine the pharmacokinetics of creatine nitrate supplementation.

Detailed Description
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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.

Official Title
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Pharmacokinetic Assessment of Acute Ingestion of Different Forms of Creatine

Conditions
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Dietary Modification

Intervention / Treatment
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* Dietary Supplement: Creatine monohydrate
* Dietary Supplement: Creatine nitrate-1
* Dietary Supplement: Creatine nitrate-2
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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;

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Creatine monohydrate<br>5 gm creatine monohydrate, 1.5 gm dextrose | Dietary Supplement: Creatine monohydrate<br>* Creatine monohydrate (5.0 g creatine monohydrate, 1.5 g dextrose)<br>|
| Active Comparator: Creatine nitrate-1<br>1 gm creatine monohydrate, 0.5 gm nitrate, 5 gm dextrose | Dietary Supplement: Creatine nitrate-1<br>* Creatine nitrate-1 (1.0 g creatine monohydrate, 0.5 g nitrate, 5.0 g dextrose)<br>|
| Active Comparator: Creatine nitrate-2<br>2 gm creatine monohydrate, 1 gm nitrate, 3.5 gm dextrose | Dietary Supplement: Creatine nitrate-2<br>* Creatine nitrate-2 (2.0 g creatine monohydrate, 1.0 g nitrate, 3.5 g dextrose)<br>|
| Placebo Comparator: Placebo<br>6.5 gm dextrose | Dietary Supplement: Placebo<br>* Placebo (6.5 g dextrose)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Examine creatine vs. creatine nitrate supplementation by assessing body water |  | One day | 
| Examine creatine vs. creatine nitrate supplementation by assessing body composition |  | One day | 
| Examine creatine vs. creatine nitrate supplementation by assessing serum creatine levels |  | One day | 
| Examine creatine vs. creatine nitrate supplementation by assessing serum nitrate levels |  | One day | 
| Examine creatine vs. creatine nitrate supplementation by assessing serum nitrite levels |  | One day | 
| Examine creatine vs. creatine nitrate supplementation by assessing flow-mediated dilation (FMD) via ultrasonography |  | One day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure standard clinical chemistry panels in the blood to evaluate safety |  | One day | 
| Measure side effects to evaluate safety utilizing a side effects questionnaire |  | One day | 
| Measure heart rate to evaluate safety |  | One day | 
| Measure blood pressure to evaluate safety |  | One day |