Assessment of a Pre-Workout Dietary Supplement

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the acute effects of a pre-workout dietary supplement on energy metabolism, cardiovascular hemodynamics, blood metabolites and mental focus.

Detailed Description
-----------------
A number of nutritional strategies have been developed to optimize nutrient delivery prior to exercise. This includes providing carbohydrate and a number of ergogenic nutrients prior to, during and/or following exercise. As a result a number of pre-workout supplements have been developed to increase energy availability, promote vasodilation and/or positively affect exercise capacity. The purpose of this study is to investigate the potential ergogenic value of acute ingestion of a pre-workout dietary supplement prior to exercise.

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

Conditions
-----------------
Dietary Modification

Intervention / Treatment
-----------------
* Dietary Supplement: C4 Extreme
* Dietary Supplement: C4 Extreme (without Advantra Z
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: you are an apparently healthy and recreationally active man or woman between the ages of 18 and 40; you will need to have at least six months immediate prior history of resistance training on the bench press and leg press or squat; Exclusion Criteria: you have a history of treatment for metabolic disease (i.e., diabetes), hypertension, hypo-tension, thyroid disease, arrhythmia and/or cardiovascular disease; you are currently using prescription medications; you have an intolerance to caffeine and/or other natural stimulants; you are pregnant or a lactating female or plan to become pregnant with the next month; you have a history of smoking; you drink excessively (i.e., 12 drinks per week or more);

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

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 Extreme<br>One dose of 12 grams (powder mixed with water): 1500 mg beta alanine, 1000 mg creatine nitrate, 1000 mg arginine AKG, 250 mg vitamin C, 150 mg n-acetyle tyrosine, 135 mg caffeine, 7.5 mg l-dopa, 30 mg vitamin B3, 10 mg synephrine, 0.5 mg vitamin B6, 0.25 mg vitamin B9, 0.035 mg vitamin B12. | Dietary Supplement: C4 Extreme<br>* Pre-Workout Dietary Supplement<br>|
| Active Comparator: C4 Extreme (without Advantra Z)<br>One dose of 12 grams (powder mixed with water): 1500 mg beta alanine, 1000 mg creatine nitrate, 1000 mg arginine AKG, 250 mg vitamin C, 150 mg n-acetyle tyrosine, 135 mg caffeine, 7.5 mg l-dopa, 30 mg vitamin B3, 0.5 mg vitamin B6, 0.25 mg vitamin B9, 0.035 mg vitamin B12. | Dietary Supplement: C4 Extreme (without Advantra Z<br>* Pre-Workout Dietary Supplement<br>|
| Placebo Comparator: Placebo<br>One dose of flavored placebo (powder mixed with water) | Dietary Supplement: Placebo<br>* Pre-Workout Dietary Supplement<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optimize nutrient delivery prior to exercise by assessing; cognitive function (i.e., Stroop Color and Word Test and Word Recall Test). |  | Three weeks | 
| Optimize nutrient delivery prior to exercise by assessing Readiness to Perform Visual Analog Scale. |  | Three weeks | 
| Optimize nutrient delivery prior to exercise by assessing Resting Energy Expenditure. |  | Three weeks | 
| Optimize nutrient delivery prior to exercise by assessing Heart Rate. |  | Three weeks | 
| Optimize nutrient delivery prior to exercise by assessing Blood Pressure. |  | Three weeks | 
| Optimize nutrient delivery prior to exercise by assessing ECG. |  | Three weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure standard clinical chemistry panels in the blood to evaluate safety. |  | Three weeks | 
| Measure Heart Rate to evaluate safety. |  | Three weeks | 
| Measure Blood Pressure to evaluate safety. |  | Three weeks | 
| Measure ECG to evaluate safety. |  | Three weeks |