Influence of Caffeinated and Non-caffeinated Pre-workout Supplements on Resistance Exercise Performance

June 2, 2021 updated by: Texas Tech University
This study is a randomized, double-blind, placebo-controlled crossover trial examining the effects of caffeinated and non-caffeinated pre-workout supplements on resistance exercise performance. Resistance-trained adults will be randomly assigned to complete three study conditions (caffeinated pre-workout, non-caffeinated pre-workout, and placebo) in one of the six possible condition orders. During each condition, participants will report to the laboratory for ingestion of the assigned beverage and subsequent muscular performance testing. Major performance outcomes will be force production variables from a mechanized squat device and maximal strength and muscular endurance on the bench press and leg press exercises.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Lubbock, Texas, United States, 79409
        • Department of Kinesiology & Sport Management

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Between the ages of 18 and 40;
  • Body mass between 50 - 100 kg (110-220 lb)
  • Generally healthy (defined as an absence of any disease or medical condition which could potentially be negatively affected by consumption of the commercially available dietary supplements or performance of exercise, including but not limited to musculoskeletal or cardiovascular diseases).
  • Resistance-trained, defined as completing 2+ resistance training sessions per week for at least three months prior to screening.
  • Participants must have reported regular training of the lower body through a multi-joint exercise such as the squat or leg press at least once weekly during the three-month period prior to screening.
  • Participants must have reported regular training of the bench press or chest press variation at least once weekly during the three-month period prior to screening.
  • Female participants will be required to bench press ≥ 0.5 x body mass and leg press ≥ 1.75 x body mass during initial 1RM assessments to be eligible for this study.
  • Male participants will be required to bench press ≥ 1.0 x body mass and leg press ≥ 3.0 x body mass to be eligible.
  • Regular caffeine consumption (due to the presence of caffeine in the commercially available dietary supplement). This will be defined as an average self-reported daily intake of 250+ mg of caffeine, which is equivalent to approximately 2.5 cups of coffee.

Exclusion Criteria:

  • Failing to meet any of the aforementioned inclusion criteria.
  • Pregnant or breastfeeding (for female participants)
  • Taking prescription medication which could reasonably make participation unsafe for the participant or influence study outcomes
  • An inability to complete resistance exercise due to injury or medical condition
  • Self-reported caffeine sensitivity, as indicated by unwanted side effects when caffeine is consumed.
  • Allergy to any of the ingredients in the test beverages or standardized breakfast.
  • Current use of anabolic steroids
  • Presence of a pacemaker or other implanted electrical device.
  • Unwillingness to wear the provided surgical mask during all testing procedures.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Caffeinated Pre-workout Supplement
This arm will consist of ingestion of the commercially available, caffeinated Pulse pre-workout, manufactured by Legion Athletics, Inc.
Dietary supplement: Caffeinated pre-workout supplement
The intervention will consist of consuming a standardized meal followed by one serving of the commercially available Pulse caffeinated pre-workout supplement (Legion Athletics, Inc.).
Other Names:
  • Legion Athletics Pulse Pre-workout Supplement
Active Comparator: Non-Caffeinated Pre-Workout Supplement
This arm will consist of ingestion of the commercially available, non-caffeinated Pulse pre-workout, manufactured by Legion Athletics, Inc.
Dietary supplement: Non-caffeinated pre-workout supplement
The intervention will consist of consuming a standardized meal followed by one serving of the commercially available Pulse non-caffeinated pre-workout supplement (Legion Athletics, Inc.).
Other Names:
  • Legion Athletics Pulse Pre-workout Supplement
Placebo Comparator: Placebo
This arm will consist of a flavor-matched placebo beverage without the active components contained in the supplements administered in the other study arms.
Dietary supplement: Placebo
The intervention will consist of consuming a standardized meal followed by a placebo beverage.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Isometric Peak Force Production
Time Frame: Approximately 35 minutes after beverage ingestion in each condition.
Peak isometric force produced on a mechanical squat device at an 120-degree knee angle.
Approximately 35 minutes after beverage ingestion in each condition.
Isometric Rate of Force Development
Time Frame: Approximately 35 minutes after beverage ingestion in each condition.
Rate of force development produced on a mechanical squat device at an 120-degree knee angle.
Approximately 35 minutes after beverage ingestion in each condition.
Isokinetic Peak Concentric Force Production
Time Frame: Approximately 40 minutes after beverage ingestion in each condition.
Peak concentric force produced during isokinetic testing on a mechanical squat device.
Approximately 40 minutes after beverage ingestion in each condition.
Isokinetic Peak Eccentric Force Production
Time Frame: Approximately 40 minutes after beverage ingestion in each condition.
Peak eccentric force produced during isokinetic testing on a mechanical squat device.
Approximately 40 minutes after beverage ingestion in each condition.
Maximal Strength on Bench Press Exercise
Time Frame: Approximately 65 minutes after beverage ingestion in each condition.
One-repetition maximum for the barbell bench press exercise.
Approximately 65 minutes after beverage ingestion in each condition.
Muscular Endurance on Bench Press Exercise
Time Frame: Approximately 70 minutes after beverage ingestion in each condition.
Repetitions to failure on the bench press exercise, using a load corresponding to 0.4 times body mass for females and 0.75 times body mass for males.
Approximately 70 minutes after beverage ingestion in each condition.
Maximal Strength on Leg Press Exercise
Time Frame: Approximately 95 minutes after beverage ingestion in each condition.
One-repetition maximum for the plate-loaded leg press exercise.
Approximately 95 minutes after beverage ingestion in each condition.
Muscular Endurance on Leg Press Exercise
Time Frame: Approximately 100 minutes after beverage ingestion in each condition.
Repetitions to failure on the leg press exercise, using a load corresponding to 1.5 times body mass for females and 2.5 times body mass for males.
Approximately 100 minutes after beverage ingestion in each condition.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Subjective Ratings of Energy
Time Frame: Five total assessments in each condition. Immediately prior to: beverage ingestion, isometric exercise testing, bench press testing, and leg press testing. Also, immediately after leg press testing.
Subjective rating of energy as indicated by visual analog scale (0 to 100, with a higher value indicating a higher rating of energy).
Five total assessments in each condition. Immediately prior to: beverage ingestion, isometric exercise testing, bench press testing, and leg press testing. Also, immediately after leg press testing.
Subjective Ratings of Focus
Time Frame: Five total assessments in each condition. Immediately prior to: beverage ingestion, isometric exercise testing, bench press testing, and leg press testing. Also, immediately after leg press testing.
Subjective rating of focus as indicated by visual analog scale (0 to 100, with a higher value indicating a higher rating of focus).
Five total assessments in each condition. Immediately prior to: beverage ingestion, isometric exercise testing, bench press testing, and leg press testing. Also, immediately after leg press testing.
Subjective Ratings of Fatigue
Time Frame: Five total assessments in each condition. Immediately prior to: beverage ingestion, isometric exercise testing, bench press testing, and leg press testing. Also, immediately after leg press testing.
Subjective rating of fatigue as indicated by visual analog scale (0 to 100, with a higher value indicating a higher rating of fatigue).
Five total assessments in each condition. Immediately prior to: beverage ingestion, isometric exercise testing, bench press testing, and leg press testing. Also, immediately after leg press testing.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Participant Identification of Beverage
Time Frame: At the very end of each condition (i.e., approximately 105 minutes after beverage ingestion in each condition; exact time of assessment may vary based on duration of exercise performance testing for each participant).
At the end of each exercise session (i.e., after leg press testing has concluded), participants will be asked to identify the test beverage they believe they received.
At the very end of each condition (i.e., approximately 105 minutes after beverage ingestion in each condition; exact time of assessment may vary based on duration of exercise performance testing for each participant).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Texas Tech University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Legion Athletics, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 23, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 11, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 11, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 11, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 15, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 3, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB2020-813
  • 20-1299 (Other Identifier: Texas Tech University Sponsored Projects)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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