Assessment of a Pre-Workout Dietary Supplement

Not Applicable

Completed

• Conditions: Dietary Modification
• Interventions: Dietary Supplement: C4 Extreme (without Advantra Z; Dietary Supplement: Placebo; Dietary Supplement: C4 Extreme

• Registration Number: NCT02952014
• Lead Sponsor: Texas A&M University

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.

Study Timeline

• Study Start: 2014-02
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Study First Submitted: 2016-09-13
• Status Verified: 2016-10
• Study First Submitted QC: 2016-10-30
• Last Update Submitted: 2016-10-30
• Study First Posted: 2016-11-02
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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);

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
C4 Extreme (without Advantra Z)	C4 Extreme (without Advantra Z	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.
Placebo	Placebo	One dose of flavored placebo (powder mixed with water)
C4 Extreme	C4 Extreme	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.

Primary Outcome Measures

Name	Time	Method
Optimize nutrient delivery prior to exercise by assessing Readiness to Perform Visual Analog Scale.	Three weeks
Optimize nutrient delivery prior to exercise by assessing Blood Pressure.	Three weeks
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 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 ECG.	Three weeks

Secondary Outcome Measures

Name	Time	Method
Measure Heart Rate to evaluate safety.	Three weeks
Measure Blood Pressure to evaluate safety.	Three weeks
Measure standard clinical chemistry panels in the blood to evaluate safety.	Three weeks
Measure ECG to evaluate safety.	Three weeks

Trial Locations

Locations (1)

Exercise & Sport Nutrition Laboratory; 🇺🇸 College Station, Texas, United States