NCT07225608

Brief Summary

The goal of this study is to learn if a new pre-workout supplement can improve exercise performance in healthy adults. It will also look at how the supplement affects mood and energy levels. The main questions it aims to answer are: Does the pre-workout supplement improve endurance and strength during exercise? Does it reduce how hard exercise feels (perceived exertion)? How does it affect participants' mood and energy? Researchers will compare the pre-workout supplement to a placebo (a look-alike powder that contains no active ingredients) to see if it works. Participants will: Take the pre-workout supplement or a placebo before exercise in two separate sessions; Complete exercise tests after taking each one; Report how they feel during and after exercise, including mood, energy, and effort. By bridging gaps in existing research, this study aims to establish a robust scientific foundation for the application of this novel pre-workout supplement in enhancing exercise outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2025

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

November 3, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 6, 2025

Completed
25 days until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2026

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 9, 2026

Completed
Last Updated

March 6, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

November 3, 2025

Last Update Submit

March 5, 2026

Conditions

Keywords

physical performanceexercise performanceendurance exerciseperceived exertionstrength endurancemoodenergyL-theanineRhodiola RoseaCreatine

Outcome Measures

Primary Outcomes (5)

  • Aerobic Endurance (Graded Cycling Test VO₂max )

    Participants will complete a graded cycling test on a calibrated cycle ergometer to assess aerobic performance. Maximal oxygen consumption (VO₂max) will be noted if a plateau is observed. using a metabolic cart to determine VO₂max.VO₂max represents the highest rate of oxygen consumption achieved during the test. Proper cycle ergometer setup, including seat height and handlebar position, will be standardized for all participants. Testing will be conducted by trained technicians for consistency.

    From baseline 70 minutes after treatment consumption, then again on day 6, 70 minutes post treatment consumption

  • Local Muscular Endurance (Bench Press to Failure)

    Participants will complete bench press assessments to evaluate muscular strength and endurance. A 5-repetition maximum (5RM) protocol will be used to determine maximal bench press strength. For muscular endurance, participants will complete two sets of bench press at 60% of their 1RM, performing repetitions to fatigue with 2 minutes of rest between sets. Total work volume will be calculated as the product of sets × repetitions. Proper spotting and form supervision will be ensured throughout.

    From baseline 50 minutes post treatment consumption, then again on day 6, 50 minutes post treatment consumption

  • Aerobic Endurance (Graded Cycling Test VO₂peak)

    Participants will complete a graded cycling test on a calibrated cycle ergometer to assess aerobic performance. Oxygen consumption (VO₂) will be continuously monitored every 15 seconds using a metabolic cart to determine VO₂peak. Peak oxygen consumption will be recorded as the highest oxygen uptake value observed during the incremental test. Proper cycle ergometer setup, including seat height and handlebar position, will be standardized for all participants. Testing will be conducted by trained technicians for consistency.

    From baseline 70 minutes after treatment consumption, then again on day 6, 70 minutes post treatment consumption

  • Aerobic Endurance (Graded Cycling Test Time to Exhaustion)

    Participants will complete a graded cycling test on a calibrated cycle ergometer to assess aerobic performance. The total duration in minutes participants are able to sustain the incremental cycling workload until volitional fatigue is recorded. This measures endurance capacity during the graded test. Proper cycle ergometer setup, including seat height and handlebar position, will be standardized for all participants. Testing will be conducted by trained technicians for consistency.

    From baseline 70 minutes after treatment consumption, then again on day 6, 70 minutes post treatment consumption

  • Aerobic Endurance (Graded Cycling Test Total Work Performed)

    Participants will complete a graded cycling test on a calibrated cycle ergometer to assess aerobic performance. Total work (kJ) will be calculated as Σ(power × time)/1000, where power = kp × 50 RPM × 6.118.. This reflects overall exercise performance. Proper cycle ergometer setup, including seat height and handlebar position, will be standardized for all participants. Testing will be conducted by trained technicians for consistency.

    From baseline 70 minutes after treatment consumption, then again on day 6, 70 minutes post treatment consumption

Secondary Outcomes (8)

  • Thayer Activation-Deactivation Adjective Checklist (ADACL)

    From baseline, 10 minutes pre treatment consumption, then 35 minutes after treatment consumption, and then again 90 minutes post treatment consumption. Until repeated on day 6.

  • Samn-Perelli Visual Analog Scale (VAS)

    From baseline, 10 minutes pre treatment consumption, then 35 minutes after treatment consumption, and then again 90 minutes post treatment consumption. Until repeated on day 6.

  • Caffeine Visual Analog Scale (VAS)

    From baseline, 10 minutes pre treatment consumption, then 35 minutes after treatment consumption, and then again 90 minutes post treatment consumption. Until repeated on day 6.

  • Muscle Strength and Strength Endurance (Isometric Mid Thigh Pull)

    From baseline 40 minutes after treatment consumption, then again on day 6, 40 minutes post treatment consumption

  • Lower Body Power and Force Generation (Maximal Countermovement Jump)

    From baseline 45 minutes after treatment consumption, then again on day 6, 45 minutes post treatment consumption

  • +3 more secondary outcomes

Study Arms (2)

proprietary pre-workout supplement

EXPERIMENTAL

Liquid IV pre-workout supplement powder

Dietary Supplement: proprietary pre-workout supplement

Control treatment

PLACEBO COMPARATOR

inactive/inert placebo mixture

Dietary Supplement: Control placebo

Interventions

Control placeboDIETARY_SUPPLEMENT

inactive/inert placebo mix

Control treatment

proprietary pre-workout supplement

proprietary pre-workout supplement

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy males or females aged 18-55
  • Must be recreationally trained or trained/developmental as previously defined (McKay et al., 2021)
  • Able to read and write in English

You may not qualify if:

  • Are not consistently taking, or will discontinue consuming other pre-workout supplements or dietary supplements, such as creatine, rhodiola, L-Theanine, glycerol, stimulants other than caffeine, or ingredients which may promote hydration or enhance physical performance within the past 2-weeks, and throughout the duration of the study.
  • Willing to restrict caffeine for 24 hours prior to testing
  • Will not participate in any strenuous exercise for a minimum of 72 hours prior to exercise performance assessments. Strenuous exercise as defined for this study includes ½ and full marathons (or more), heavy (i.e.,\>80% 1RM) lifting, and any high intensity, physical activity that could make your muscles sore.
  • Sedentary: Individuals performing less than 150 minutes of moderate or 75 minutes of vigorous activity per week and engaging in resistance training fewer than 2 days per week, with no structured exercise routine.
  • Highly trained/national level or professional athlete: Individuals training ≥5 days per week in structured programs, including NCAA Division II/III athletes, national/professional competitors, or those targeting top 20% sport-specific performance norms.
  • Known diagnosis of any cardiovascular, metabolic, endocrine, or renal disease
  • Recent musculoskeletal injury (\<3-months)
  • Recent orthopaedic surgery (\<12-months)
  • History or current malignancy
  • Previous gastrointestinal surgery within the past 12 months
  • Regular smoker
  • Regular drinker (\>14 drinks per week)
  • Current respiratory infection (i.e. cold) or high temperature (fever) within the past 4-weeks
  • Presently using GLP-1 medications
  • Individuals with cardiovascular, metabolic, or musculoskeletal disorders;
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Applied Science & Performance Institute

Tampa, Florida, 33634, United States

Location

Study Officials

  • Eric Sikorski, PhD

    Applied Science and Performance Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: randomized, double-blind, crossover study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2025

First Posted

November 6, 2025

Study Start

December 1, 2025

Primary Completion

February 2, 2026

Study Completion

February 9, 2026

Last Updated

March 6, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations