- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04712578
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
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
24
Phase
- 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
-
-
Texas
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Lubbock, Texas, United States, 79409
- Department of Kinesiology & Sport Management
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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
Ages Eligible for Study
16 years to 38 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 |
Intervention / Treatment |
---|---|
Experimental: Caffeinated Pre-workout Supplement
This arm will consist of ingestion of the commercially available, caffeinated Pulse pre-workout, manufactured by Legion Athletics, Inc.
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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:
|
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.
|
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:
|
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.
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The intervention will consist of consuming a standardized meal followed by a placebo beverage.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Isometric Peak Force Production
Time Frame: Approximately 35 minutes after beverage ingestion in each condition.
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Peak isometric force produced on a mechanical squat device at an 120-degree knee angle.
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Approximately 35 minutes after beverage ingestion in each condition.
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Isometric Rate of Force Development
Time Frame: Approximately 35 minutes after beverage ingestion in each condition.
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Rate of force development produced on a mechanical squat device at an 120-degree knee angle.
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Approximately 35 minutes after beverage ingestion in each condition.
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Isokinetic Peak Concentric Force Production
Time Frame: Approximately 40 minutes after beverage ingestion in each condition.
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Peak concentric force produced during isokinetic testing on a mechanical squat device.
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Approximately 40 minutes after beverage ingestion in each condition.
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Isokinetic Peak Eccentric Force Production
Time Frame: Approximately 40 minutes after beverage ingestion in each condition.
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Peak eccentric force produced during isokinetic testing on a mechanical squat device.
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Approximately 40 minutes after beverage ingestion in each condition.
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Maximal Strength on Bench Press Exercise
Time Frame: Approximately 65 minutes after beverage ingestion in each condition.
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One-repetition maximum for the barbell bench press exercise.
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Approximately 65 minutes after beverage ingestion in each condition.
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Muscular Endurance on Bench Press Exercise
Time Frame: Approximately 70 minutes after beverage ingestion in each condition.
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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.
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Approximately 70 minutes after beverage ingestion in each condition.
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Maximal Strength on Leg Press Exercise
Time Frame: Approximately 95 minutes after beverage ingestion in each condition.
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One-repetition maximum for the plate-loaded leg press exercise.
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Approximately 95 minutes after beverage ingestion in each condition.
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Muscular Endurance on Leg Press Exercise
Time Frame: Approximately 100 minutes after beverage ingestion in each condition.
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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.
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Approximately 100 minutes after beverage ingestion in each condition.
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Secondary Outcome Measures
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.
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Subjective rating of energy as indicated by visual analog scale (0 to 100, with a higher value indicating a higher rating of energy).
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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.
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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.
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Subjective rating of focus as indicated by visual analog scale (0 to 100, with a higher value indicating a higher rating of focus).
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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.
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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.
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Subjective rating of fatigue as indicated by visual analog scale (0 to 100, with a higher value indicating a higher rating of fatigue).
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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.
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Other Outcome Measures
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).
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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.
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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).
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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)
February 23, 2021
Primary Completion (Actual)
May 11, 2021
Study Completion (Actual)
May 11, 2021
Study Registration Dates
First Submitted
January 11, 2021
First Submitted That Met QC Criteria
January 14, 2021
First Posted (Actual)
January 15, 2021
Study Record Updates
Last Update Posted (Actual)
June 3, 2021
Last Update Submitted That Met QC Criteria
June 2, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID 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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