Assessment of a Pre-Workout Dietary Supplement (NB1)

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

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.

Study Overview

• Status: Completed
• Conditions: Dietary Modification
• Intervention / Treatment: Dietary supplement: C4 Extreme; Dietary supplement: C4 Extreme (without Advantra Z; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • College Station, Texas, United States, 77843
      • Exercise & Sport Nutrition Laboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: C4 Extreme; Pre-Workout Dietary Supplement
Active Comparator: 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.	Dietary supplement: C4 Extreme (without Advantra Z; Pre-Workout Dietary Supplement
Placebo Comparator: Placebo; One dose of flavored placebo (powder mixed with water)	Dietary supplement: Placebo; Pre-Workout Dietary Supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Texas A&M University
• Collaborators: Nutrabolt
• Investigators: Principal Investigator: Richard B Kreider, PhD, Texas A&M University

Publications and helpful links

General Publications

• Jung YP, Earnest CP, Koozehchian M, Galvan E, Dalton R, Walker D, Rasmussen C, Murano PS, Greenwood M, Kreider RB. Effects of acute ingestion of a pre-workout dietary supplement with and without p-synephrine on resting energy expenditure, cognitive function and exercise performance. J Int Soc Sports Nutr. 2017 Jan 12;14:3. doi: 10.1186/s12970-016-0159-2. eCollection 2017.

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: September 13, 2016
• First Submitted That Met QC Criteria: October 30, 2016
• First Posted (Estimate): November 2, 2016

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: October 30, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: IRB2014-0022FX

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO