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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04712578
Other study ID # IRB2020-813
Secondary ID 20-1299
Status Completed
Phase N/A
First received
Last updated
Start date February 23, 2021
Est. completion date May 11, 2021

Study information

Verified date June 2021
Source Texas Tech University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date May 11, 2021
Est. primary completion date May 11, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.).
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.).
Placebo
The intervention will consist of consuming a standardized meal followed by a placebo beverage.

Locations

Country Name City State
United States Department of Kinesiology & Sport Management Lubbock Texas

Sponsors (2)

Lead Sponsor Collaborator
Texas Tech University Legion Athletics, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Participant Identification of Beverage 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).
Primary Isometric Peak Force Production Peak isometric force produced on a mechanical squat device at an 120-degree knee angle. Approximately 35 minutes after beverage ingestion in each condition.
Primary Isometric Rate of Force Development 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.
Primary Isokinetic Peak Concentric Force Production Peak concentric force produced during isokinetic testing on a mechanical squat device. Approximately 40 minutes after beverage ingestion in each condition.
Primary Isokinetic Peak Eccentric Force Production Peak eccentric force produced during isokinetic testing on a mechanical squat device. Approximately 40 minutes after beverage ingestion in each condition.
Primary Maximal Strength on Bench Press Exercise One-repetition maximum for the barbell bench press exercise. Approximately 65 minutes after beverage ingestion in each condition.
Primary 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. Approximately 70 minutes after beverage ingestion in each condition.
Primary Maximal Strength on Leg Press Exercise One-repetition maximum for the plate-loaded leg press exercise. Approximately 95 minutes after beverage ingestion in each condition.
Primary 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. Approximately 100 minutes after beverage ingestion in each condition.
Secondary 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). 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.
Secondary 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). 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.
Secondary 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). 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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