NCT04712578

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 15, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

February 23, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 11, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2021

Completed
Last Updated

June 3, 2021

Status Verified

June 1, 2021

Enrollment Period

3 months

First QC Date

January 11, 2021

Last Update Submit

June 2, 2021

Conditions

Keywords

caffeineresistance trainingresistance exercisepre-workout supplementdietary supplements

Outcome Measures

Primary Outcomes (8)

  • 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.

  • 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.

  • 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.

  • 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.

  • Maximal Strength on Bench Press Exercise

    One-repetition maximum for the barbell bench press exercise.

    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.

    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.

    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.

    Approximately 100 minutes after beverage ingestion in each condition.

Secondary Outcomes (3)

  • Subjective Ratings 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

    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

    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 Outcomes (1)

  • Participant Identification of Beverage

    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).

Study Arms (3)

Caffeinated Pre-workout Supplement

EXPERIMENTAL

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

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.

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.

Dietary Supplement: Placebo

Interventions

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.).

Also known as: Legion Athletics Pulse Pre-workout Supplement
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.).

Also known as: Legion Athletics Pulse Pre-workout Supplement
Non-Caffeinated Pre-Workout Supplement
PlaceboDIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Kinesiology & Sport Management

Lubbock, Texas, 79409, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
All investigators will be blinded to the caffeinated vs. non-caffeinated supplement (i.e., these were provided by the manufacturer in a blinded manner). Select study investigators who will not be involved in assessing outcomes will formulate the placebo supplement and be responsible for dispensing all supplements to participants. Supplements will be provided to participants in opaque containers to maintain blinding. All investigators involved in assessing outcomes will also remain blinded and will not be involved in handling or dispensing the supplements.
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: This study is a randomized, double-blind, placebo-controlled crossover trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2021

First Posted

January 15, 2021

Study Start

February 23, 2021

Primary Completion

May 11, 2021

Study Completion

May 11, 2021

Last Updated

June 3, 2021

Record last verified: 2021-06

Locations