Effects of a Pre-Workout Dietary Supplement on Training Adaptations

NCT02999581 | Completed DMC

• 1 other identifier: IRB2014-0079FX
• Study Type: interventional
• Target: 122
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Dietary Modification

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (4)

• 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

Study Arms (3)

C4 Extreme

EXPERIMENTAL

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)

C4 Extreme (without Advantra Z)

ACTIVE COMPARATOR

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

PLACEBO COMPARATOR

One dose of flavored placebo (powder mixed with water)

Dietary Supplement: C4 Extreme, C4 Extreme (without Advantra Z)

Interventions

C4 Extreme, C4 Extreme (without Advantra Z) DIETARY_SUPPLEMENT

C4 Extreme; C4 Extreme (without Advantra Z); Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• Texas A&M University: lead
• Nutrabolt: collaborator

Related Publications (1)

• 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.

  PMID: 28096757 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2016
• First Posted: December 21, 2016
• Study Start: March 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 21, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share