Assessment of a Pre-Workout Supplement

Study Overview
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Brief Summary
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This study is assessing the effects of a pre-workout dietary supplement.

Detailed Description
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The purpose of this study is to examine the acute effects of a pre-workout dietary supplement at a standard dose and one that is delivered at 150% of the standard dose on energy metabolism, cardiovascular hemodynamics, blood metabolites and mental focus.

Official Title
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Pharmacokinetic, Hemodynamic and Ergogenic Assessment of a Pre-Workout Dietary Supplement

Conditions
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Exercise Ergogenics

Intervention / Treatment
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* Dietary Supplement: C4/Generation 4
* Dietary Supplement: C450X
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must be apparently healthy males and/or females between the ages of 18 and 40 Participants must have at least 6 months immediate prior history of resistance training including the bench press and leg press/squat Exclusion Criteria: Participants who have a history of treatment for metabolic disease (i.e., diabetes), hypertension, hypotension, thyroid disease, arrhythmias and/or cardiovascular disease Participants who currently use any prescription medication Participants who are intolerant to caffeine and/or other natural stimulants Participants who are pregnant or lactating women Participants who have a history of smoking Participants who drink excessively (12 drinks per week)

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: C4/Generation 4<br>12 grams of C4/Generation 4 Extreme | Dietary Supplement: C4/Generation 4<br>* 12 grams of C4/Generation 4<br>|
| Active Comparator: C450X<br>12 grams of C4X (150% of regular dose) | Dietary Supplement: C450X<br>* 12 grams of C450X<br>|
| Placebo Comparator: Placebo<br>12 grams of flavored dextrose | Dietary Supplement: Placebo<br>* 12 grams of flavored dextrose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of a Pre-Workout Dietary Supplement on the Stroop Color and Word Test |  | Seven Days | 
| Effects of a Pre-Workout Dietary Supplement on the Word Recall Test |  | Seven Days | 
| Effects of a Pre-Workout Dietary Supplement on VAS Readiness to Perform |  | Seven Days | 
| Effects of a Pre-Workout Dietary Supplement on anaerobic sprint capacity on a bicycle ergometer |  | Seven Days | 
| Effects of a Pre-Workout Dietary Supplement on bench press power output |  | Seven Days | 
| Effects of a Pre-Workout Dietary Supplement on leg press power output |  | Seven Days | 
| Effects of a Pre-Workout Dietary Supplement on total work on the bench press |  | Seven Days | 
| Effects of a Pre-Workout Dietary Supplement on total work on the leg press |  | Seven Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of a Pre-Workout Dietary Supplement on energy expenditure |  | Seven Days | 
| Effects of a Pre-Workout Dietary Supplement on heart rate |  | Seven Days | 
| Effects of a Pre-Workout Dietary Supplement on blood pressure |  | Seven Days | 
| Effects of a Pre-Workout Dietary Supplement on ECG's |  | Seven Days | 
| Effects of a Pre-Workout Dietary Supplement on blood lab results |  | Seven Days |