Resistance TrainingNCT04712578
Influence of Caffeinated and Non-caffeinated Pre-workout Supplements on Resistance Exercise Performance
A study testing Caffeinated pre-workout supplement and Non-caffeinated pre-workout supplement in people with Resistance Training and Caffeine, run by Texas Tech University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Resistance Training, Caffeine, Dietary Supplements
- What is being tested?
- Caffeinated pre-workout supplement and Non-caffeinated pre-workout supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2021to 11 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Kinesiology & Sport Management
Lubbock, Texas, 79409
About this study
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.
- Conditions
- Resistance Training, Caffeine, Dietary Supplements
- Being tested
- Caffeinated pre-workout supplement, Non-caffeinated pre-workout supplement, Placebo
- Keywords
- caffeine, resistance training, resistance exercise, pre-workout supplement, dietary supplements
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caffeinated pre-workout supplementDietary supplement
Also called Legion Athletics Pulse 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.).
Non-caffeinated pre-workout supplementDietary supplement
Also called Legion Athletics Pulse 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.).
PlaceboDietary supplement
The intervention will consist of consuming a standardized meal followed by a placebo beverage.
| Study group | Role | What they receive |
|---|---|---|
| Caffeinated Pre-workout Supplement | Experimental | This arm will consist of ingestion of the commercially available, caffeinated Pulse pre-workout, manufactured by Legion Athletics, Inc. Receives: Dietary Supplement: Caffeinated pre-workout supplement |
| Non-Caffeinated Pre-Workout Supplement | Active comparator | This arm will consist of ingestion of the commercially available, non-caffeinated Pulse pre-workout, manufactured by Legion Athletics, Inc. Receives: Dietary Supplement: Non-caffeinated pre-workout supplement |
| Placebo | Placebo comparator | This arm will consist of a flavor-matched placebo beverage without the active components contained in the supplements administered in the other study arms. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isometric Peak Force Production
Peak isometric force produced on a mechanical squat device at an 120-degree knee angle.
Measured: Approximately 35 minutes after beverage ingestion in each condition.
Isometric Rate of Force Development
Rate of force development produced on a mechanical squat device at an 120-degree knee angle.
Measured: Approximately 35 minutes after beverage ingestion in each condition.
Isokinetic Peak Concentric Force Production
Peak concentric force produced during isokinetic testing on a mechanical squat device.
Measured: Approximately 40 minutes after beverage ingestion in each condition.
Isokinetic Peak Eccentric Force Production
Peak eccentric force produced during isokinetic testing on a mechanical squat device.
Measured: Approximately 40 minutes after beverage ingestion in each condition.
Maximal Strength on Bench Press Exercise
One-repetition maximum for the barbell bench press exercise.
Measured: Approximately 65 minutes after beverage ingestion in each condition.
Muscular Endurance on Bench Press Exercise
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.
Measured: Approximately 70 minutes after beverage ingestion in each condition.
Maximal Strength on Leg Press Exercise
One-repetition maximum for the plate-loaded leg press exercise.
Measured: Approximately 95 minutes after beverage ingestion in each condition.
Muscular Endurance on Leg Press Exercise
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.
Measured: Approximately 100 minutes after beverage ingestion in each condition.
Secondary outcomes (3)
Subjective Ratings of Energy
Subjective rating of energy as indicated by visual analog scale (0 to 100, with a higher value indicating a higher rating of energy).
Measured: 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
Subjective rating of focus as indicated by visual analog scale (0 to 100, with a higher value indicating a higher rating of focus).
Measured: 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
Subjective rating of fatigue as indicated by visual analog scale (0 to 100, with a higher value indicating a higher rating of fatigue).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start23 Feb 2021
- Primary completion11 May 2021
- Study completion11 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resistance TrainingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study is a randomized, double-blind, placebo-controlled crossover trial.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University
- Sponsor type
- University, hospital or other
- Collaborators
- Legion Athletics, Inc
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04712578
- Sponsor's protocol ID
- IRB2020-813
- Other IDs
- 20-1299
- Status last verified
- Jun 2021
- First submitted
- 11 Jan 2021
- Last updated
- 3 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Caffeinated and Non-caffeinated Pre-workout Supplements on Resistance Exercise Performance
- ClinicalTrials.gov ID
- NCT04712578
- Acronym / sponsor ID
- IRB2020-813
- Conditions
- Resistance Training, Caffeine, Dietary Supplements
- Keywords
- caffeine, resistance training, resistance exercise, pre-workout supplement, dietary supplements
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Texas Tech UniversityUniversity, hospital or other
- Collaborators
- Legion Athletics, Inc
- Study start
- 23 Feb 2021 (actual)
- Primary completion
- 11 May 2021 (actual)
- Study completion
- 11 May 2021 (actual)
- First posted
- 15 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This study is a randomized, double-blind, placebo-controlled crossover trial.
| Arm | Type | Receives |
|---|---|---|
| Caffeinated Pre-workout Supplement | Experimental | Dietary Supplement: Caffeinated pre-workout supplementThis arm will consist of ingestion of the commercially available, caffeinated Pulse pre-workout, manufactured by Legion Athletics, Inc. |
| Non-Caffeinated Pre-Workout Supplement | Active comparator | Dietary Supplement: Non-caffeinated pre-workout supplementThis arm will consist of ingestion of the commercially available, non-caffeinated Pulse pre-workout, manufactured by Legion Athletics, Inc. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThis arm will consist of a flavor-matched placebo beverage without the active components contained in the supplements administered in the other study arms. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caffeinated pre-workout supplementAlso: Legion Athletics Pulse Pre-workout SupplementThe intervention will consist of consuming a standardized meal followed by one serving of the commercially available Pulse caffeinated pre-workout supplement (Legion Athletics, Inc.). | Dietary supplement | Caffeinated Pre-workout Supplement |
| Non-caffeinated pre-workout supplementAlso: Legion Athletics Pulse Pre-workout SupplementThe 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.). | Dietary supplement | Non-Caffeinated Pre-Workout Supplement |
| PlaceboThe intervention will consist of consuming a standardized meal followed by a placebo beverage. | Dietary supplement | Placebo |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
3 secondary outcomes
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 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 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caffeinated pre-workout supplement and Non-caffeinated pre-workout supplement in people with Resistance Training and Caffeine, run by Texas Tech University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isometric Peak Force Production (time frame: Approximately 35 minutes after beverage ingestion in each condition.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2021.