Safety of Different Forms of Creatine

Study Overview
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Brief Summary
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This study will aim to determine whether ingesting creatine nitrate (CrN) at higher doses will differentially affect hemodynamic variables compared to a placebo.

Detailed Description
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This study will examine the short-term (7 day) characteristics of ingesting creatine nitrate (CrN) compared to placebo on Chem-15 blood safety, heart rate, blood pressure, heart rate and blood pressure reactivity and self-reported side effects.

Official Title
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Short-Term Safety and Dose Effects of Different Forms of Creatine

Conditions
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Nutritional Supplements

Intervention / Treatment
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* Dietary Supplement: Creatine nitrate, low dose
* Dietary Supplement: Creatine nitrate, high dose
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Apparently healthy At least 6 months immediate prior history of resistance training including bench press and leg press or squat Exclusion Criteria: A history of treatment for metabolic disease (i.e., diabetes), hypertension, hypotension, thyroid disease, arrhythmias and/or cardiovascular disease Use of prescription medication (birth control is allowed) Pregnant or nursing or plan to become pregnant during the next month Creatine or nitrate use in the last eight weeks History of smoking History of drinking (i.e., 12 drinks per week or more) Use of nonsteroidal anti-inflammatory drugs (NSAIDs) including ibuprofen (Advil, Motrin, Nuprin, etc.), indomethacin (Indocin), naproxen (Aleve, Anaprox, Naprelan, Naprosyn), piroxicam (Feldene)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

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 nitrate, low dose<br>Creatine nitrate at 3.0 grams (2.0 grams creatine; 1.0 gram nitrate, 3.0 grams dextrose) | Dietary Supplement: Creatine nitrate, low dose<br>* Creatine nitrate at 3.0 grams (2.0 grams creatine, 1.0 gram nitrate, 3.0 grams dextrose)<br>|
| Active Comparator: Creatine nitrate, high dose<br>Creatine nitrate at 6.0 grams (4.0 grams creatine; 2.0 grams nitrate) | Dietary Supplement: Creatine nitrate, high dose<br>* Creatine nitrate at 6.0 grams (4.0 grams creatine, 2.0 grams nitrate)<br>|
| Placebo Comparator: Placebo<br>Placebo at 6.0 grams dextrose | Dietary Supplement: Placebo<br>* Placebo at 6.0 grams (6.0 grams dextrose)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measuring the blood pressure response to creatine nitrate ingestion |  | 7 days | 
| Measuring the heart rate response to creatine nitrate ingestion |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measuring a blood chemistry panel 15 response to creatine nitrate ingestion |  | 7 days | 
| Measuring the one Repetition Maximum (1 RM) muscle strength response to creatine nitrate ingestion |  | 7 days | 
| Measuring the repetitions to failure muscle endurance response to creatine nitrate ingestion |  | 7 days | 
| Measuring self-reported side effects of creatine nitrate ingestion |  | 7 days |