Effects of a Pre-Workout Dietary Supplement on Training Adaptations

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the effects of a pre-workout dietary supplement during resistance training on training adaptations.

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 effects of ingesting a pre-workout dietary supplement during resistance training on training adaptations.

Official Title
-----------------
Effects of a Pre-Workout Dietary Supplement on Training Adaptations in Resistance Trained Athletes

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: you are an apparently healthy and recreationally active male 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, hypotension, 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 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
-----------------
Male

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel 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 alpha-ketoglutarate, 250 mg vitamin C, 150 mg N-Acetyl-Tyrosine, 135 mg caffeine, 7.5 mg L-Dopa, 30 mg vitamin B3, 10 mg Bitter Orange (Citrus Aurantium) fruit standardized for 30% synephrine (Advantra Z), 0.5 mg vitamin B6, 0.25 mg vitamin B9, and 0.035 mg vitamin B12. | Dietary Supplement: C4 Extreme, C4 Extreme (without Advantra Z)<br> <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 alpha-ketoglutarate, 250 mg vitamin C, 150 mg N-Acetyl-Tyrosine, 135 mg caffeine, 7.5 mg L-Dopa, 30 mg vitamin B3, 0.5 mg vitamin B6, 0.25 mg vitamin B9, and 0.035 mg vitamin B12. | Dietary Supplement: C4 Extreme, C4 Extreme (without Advantra Z)<br> <br> |
| Placebo Comparator: Placebo<br>One dose of flavored placebo (powder mixed with water) | Dietary Supplement: C4 Extreme, C4 Extreme (without Advantra Z)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Examine the effects of C4 supplementation during resistance training by assessing body water |  | Eight weeks | 
| Examine the effects of C4 supplementation during resistance training by assessing body composition |  | Eight weeks | 
| Examine the effects of C4 supplementation during resistance training by assessing macronutrient intake |  | Eight weeks | 
| Examine the effects of C4 supplementation during resistance training by assessing 1 RM (repetition maximum) strength |  | Eight weeks | 
| Examine the effects of C4 supplementation during resistance training by assessing anaerobic sprint capacity |  | Eight weeks | 
| Examine the effects of C4 supplementation during resistance training by assessing muscle creatine levels |  | Eight weeks | 
| Examine the effects of C4 supplementation during resistance training by assessing muscle carnosine levels |  | Eight weeks | 
| Examine the effects of C4 supplementation during resistance training by assessing cognitive function (i.e., Stroop Color and Word Test, Word Recall Test and Readiness to perform VAS) |  | Eight weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure standard clinical chemistry panels in the blood to evaluate safety |  | Eight weeks | 
| Record side effects to evaluate safety |  | Eight weeks | 
| Measure heart rate to evaluate safety |  | Eight weeks | 
| Measure blood pressure to evaluate safety |  | Eight weeks |