Effects of a Pre-Workout Dietary Supplement on Training Adaptations (NB2)

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

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

Study Overview

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

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.

• Study Type: Interventional
• Enrollment (Actual): 122
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

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

Description

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);

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• 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 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)
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 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)
PLACEBO_COMPARATOR: Placebo; One dose of flavored placebo (powder mixed with water)	Dietary supplement: C4 Extreme, C4 Extreme (without Advantra Z)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Texas A&M University
• Collaborators: Nutrabolt

Publications and helpful links

General Publications

• Jung YP, Earnest CP, Koozehchian M, Cho M, Barringer N, Walker D, Rasmussen C, Greenwood M, Murano PS, Kreider RB. Effects of ingesting a pre-workout dietary supplement with and without synephrine for 8 weeks on training adaptations in resistance-trained males. J Int Soc Sports Nutr. 2017 Jan 3;14:1. doi: 10.1186/s12970-016-0158-3. eCollection 2017.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (ACTUAL): December 1, 2014
• Study Completion (ACTUAL): December 1, 2014

Study Registration Dates

• First Submitted: December 16, 2016
• First Submitted That Met QC Criteria: December 16, 2016
• First Posted (ESTIMATE): December 21, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): December 21, 2016
• Last Update Submitted That Met QC Criteria: December 16, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: IRB2014-0079FX

Plan for Individual participant data (IPD)

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