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Assessment of a Pre-Workout Dietary Supplement (NB1)

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ClinicalTrials.gov Identifier: NCT02952014
Recruitment Status : Completed
First Posted : November 2, 2016
Last Update Posted : November 2, 2016
Sponsor:
Collaborator:
Nutrabolt
Information provided by (Responsible Party):
Texas A&M University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dietary Modification Dietary Supplement: C4 Extreme Dietary Supplement: C4 Extreme (without Advantra Z Dietary Supplement: Placebo 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 potential ergogenic value of acute ingestion of a pre-workout dietary supplement prior to exercise.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Health Services Research
Official Title: Pharmacokinetic, Thermogenic, Hemodynamic, Ergogenic Assessment of a Pre-Workout Dietary Supplement
Study Start Date : February 2014
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Optimize nutrient delivery prior to exercise by assessing; cognitive function (i.e., Stroop Color and Word Test and Word Recall Test). [ Time Frame: Three weeks ]
  2. Optimize nutrient delivery prior to exercise by assessing Readiness to Perform Visual Analog Scale. [ Time Frame: Three weeks ]
  3. Optimize nutrient delivery prior to exercise by assessing Resting Energy Expenditure. [ Time Frame: Three weeks ]
  4. Optimize nutrient delivery prior to exercise by assessing Heart Rate. [ Time Frame: Three weeks ]
  5. Optimize nutrient delivery prior to exercise by assessing Blood Pressure. [ Time Frame: Three weeks ]
  6. Optimize nutrient delivery prior to exercise by assessing ECG. [ Time Frame: Three weeks ]

Secondary Outcome Measures :
  1. Measure standard clinical chemistry panels in the blood to evaluate safety. [ Time Frame: Three weeks ]
  2. Measure Heart Rate to evaluate safety. [ Time Frame: Three weeks ]
  3. Measure Blood Pressure to evaluate safety. [ Time Frame: Three weeks ]
  4. Measure ECG to evaluate safety. [ Time Frame: Three weeks ]


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

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);

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02952014


Locations
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United States, Texas
Exercise & Sport Nutrition Laboratory
College Station, Texas, United States, 77843
Sponsors and Collaborators
Texas A&M University
Nutrabolt
Investigators
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Principal Investigator: Richard B Kreider, PhD Texas A&M University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Texas A&M University
ClinicalTrials.gov Identifier: NCT02952014     History of Changes
Other Study ID Numbers: IRB2014-0022FX
First Posted: November 2, 2016    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No