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Completed

NCT Number: NCT02952014

Assessment of a Pre-Workout Dietary Supplement

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Exercise & Sport Nutrition Laboratory

College Station, Texas, 77843, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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);

Treatment and study plan

C4 Extreme

Dietary Supplement

Pre-Workout Dietary Supplement

C4 Extreme (without Advantra Z

Dietary Supplement

Pre-Workout Dietary Supplement

Placebo

Dietary Supplement

Pre-Workout Dietary Supplement

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Texas A&M University

Other

Collaborators

  • Nutrabolt

Registry information

Official study title

Pharmacokinetic, Thermogenic, Hemodynamic, Ergogenic Assessment of a Pre-Workout Dietary Supplement

Acronym: NB1

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Nov 2, 2016
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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