Effects of a Pre-Workout Dietary Supplement on Training Adaptations

Dietary Modification Clinical Trial

— NB2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02999581
• Other study ID #: IRB2014-0079FX
• Status: Completed
• Phase: N/A
• First received: December 16, 2016
• Last updated: December 16, 2016
• Start date: March 2014
• Est. completion date: December 2014

Study information

• Verified date: December 2016
• Source: Texas A&M University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Dietary Modification

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Texas A&M University	Nutrabolt

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Examine the effects of C4 supplementation during resistance training by assessing body water		Eight weeks	No
Primary	Examine the effects of C4 supplementation during resistance training by assessing body composition		Eight weeks	No
Primary	Examine the effects of C4 supplementation during resistance training by assessing macronutrient intake		Eight weeks	No
Primary	Examine the effects of C4 supplementation during resistance training by assessing 1 RM (repetition maximum) strength		Eight weeks	No
Primary	Examine the effects of C4 supplementation during resistance training by assessing anaerobic sprint capacity		Eight weeks	No
Primary	Examine the effects of C4 supplementation during resistance training by assessing muscle creatine levels		Eight weeks	No
Primary	Examine the effects of C4 supplementation during resistance training by assessing muscle carnosine levels		Eight weeks	No
Primary	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	No
Secondary	Measure standard clinical chemistry panels in the blood to evaluate safety		Eight weeks	Yes
Secondary	Record side effects to evaluate safety		Eight weeks	Yes
Secondary	Measure heart rate to evaluate safety		Eight weeks	Yes
Secondary	Measure blood pressure to evaluate safety		Eight weeks	Yes