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

• ClinicalTrials.gov Identifier: NCT02999581
• Recruitment Status: Completed
• First Posted: December 21, 2016
• Last Update Posted: December 21, 2016
• Sponsor: Texas A&M University
• Collaborator: Nutrabolt
• Information provided by (Responsible Party): Texas A&M University

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Dietary Modification	Dietary Supplement: C4 Extreme, C4 Extreme (without Advantra Z)	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 122 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Health Services Research
• Official Title: Effects of a Pre-Workout Dietary Supplement on Training Adaptations in Resistance Trained Athletes
• Study Start Date: March 2014
• Actual Primary Completion Date: December 2014
• Actual Study Completion Date: December 2014

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures :

1. Examine the effects of C4 supplementation during resistance training by assessing body water [ Time Frame: Eight weeks ]
2. Examine the effects of C4 supplementation during resistance training by assessing body composition [ Time Frame: Eight weeks ]
3. Examine the effects of C4 supplementation during resistance training by assessing macronutrient intake [ Time Frame: Eight weeks ]
4. Examine the effects of C4 supplementation during resistance training by assessing 1 RM (repetition maximum) strength [ Time Frame: Eight weeks ]
5. Examine the effects of C4 supplementation during resistance training by assessing anaerobic sprint capacity [ Time Frame: Eight weeks ]
6. Examine the effects of C4 supplementation during resistance training by assessing muscle creatine levels [ Time Frame: Eight weeks ]
7. Examine the effects of C4 supplementation during resistance training by assessing muscle carnosine levels [ Time Frame: Eight weeks ]
8. 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) [ Time Frame: Eight weeks ]

Secondary Outcome Measures :

1. Measure standard clinical chemistry panels in the blood to evaluate safety [ Time Frame: Eight weeks ]
2. Record side effects to evaluate safety [ Time Frame: Eight weeks ]
3. Measure heart rate to evaluate safety [ Time Frame: Eight weeks ]
4. Measure blood pressure to evaluate safety [ Time Frame: Eight weeks ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 40 Years (Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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);

Contacts and Locations

No Contacts or Locations Provided

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Texas A&M University
• ClinicalTrials.gov Identifier: NCT02999581
• Other Study ID Numbers: IRB2014-0079FX
• First Posted: December 21, 2016
• Last Update Posted: December 21, 2016
• Last Verified: December 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No