NCT06883292

Brief Summary

The purpose of this clinical trial is to look at tyrosol's effects on endurance, strength, and fatigue resistance in humans. Additionally, the combination of tyrosol and creatine monohydrate will also be looked at to determine if there is a cooperative effect from using both together. It will be conducted over a 4-week period to compare the effects of the following substances: 1) tyrosol, 2) a placebo (a look-alike substance that contains no drug), 3) creatine, and 4) a combination containing both creatine and tyrosol. Endurance, strength, and fatigue resistance will be compared between groups through repeated testing (described below). Participants who pass initial screening will be invited on-site for day one (Visit 1) of testing where they will proceed with a series of tests which will include the following: (1) body composition; (2) cognitive testing; (3) full-body strength testing; (4) grip strength on both hands; (5) muscle power testing; (6 \& 7) Resting blood lactic acid testing followed by 5RM (repetition maximum) bench press, leading to multiple sets of bench press (based on the previous weight) completed to failure, followed by another blood lactic acid reading; (8) a repeat of the muscle power testing; (9) a 1 mile time trial run completed as fast as possible. After the 4-week supplementation period (\~28-34 days), all original measures will be repeated as before in the same order (Visit 2). Approximately 24 hours later (Visit 3) participants will then repeat all physical testing procedures except tests 1, 6, 7, and 8, to determine physical recovery. Additionally, questionnaires for soreness and perceived recovery will also be completed at the beginning of Visit 2 and 3, and again on its own as the only testing event at 48 hours post-Visit 2 (visit 4).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 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

February 27, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 19, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

March 24, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2025

Completed
Last Updated

September 11, 2025

Status Verified

September 1, 2025

Enrollment Period

5 months

First QC Date

February 27, 2025

Last Update Submit

September 10, 2025

Conditions

Keywords

tyrosolcreatinemuscle strengthmuscle endurancemuscle recoverymuscle performancereaction time

Outcome Measures

Primary Outcomes (7)

  • Mid Thigh Pull

    Utilizing a pronated clean grip, subjects will be instructed to assume a body position similar to the second pull of the snatch and clean. Once body positioning is stabilized, the subject will be given a countdown. Minimal pre-tension will be allowed to eliminate slack prior to initiation of the IMTP. Each subject will perform two warm-up reps, one at 50% and one at 75% of perceived maximum effort. Thereafter, subjects will complete two maximal IMTPs separated by approximately two minutes of rest. Force kinematics from the IMTP will be collected and recorded using a linear position transducer.

    Performed one time at baseline (visit 1), at day 28 (visit 2), and day 29 (visit 3)

  • 1-mile run

    Participants will complete the 1-mile run time trial on a treadmill. The treadmill allows participants to adjust the speed as needed to maintain their maximal sustainable pace throughout the test. The total time taken to complete the 1 mile will be recorded as the primary performance measure.

    Performed one time at baseline (visit 1), at day 28 (visit 2), and day 29 (visit 3)

  • Rate of Perceived Exertion (RPE)

    RPE will be collected during the 1 mile run using Borg RPE scale (Borg, 1982). Participants will be asked to select a number on the scale to rate their overall effort. A rating of 6 is said to be no effort (rest) and a rating of 20 is considered to be maximal effort. All perceptual measures will be collected in isolation from other participants to promote accuracy and recorded as arbitrary units (a.u.).

    Performed at 0, 0.25, 0.5, 0.75, and 1.0 miles during the 1-mile run at baseline (visit 1), at day 28 (visit 2), and day 29 (visit 3)

  • Grip Strength

    Grip strength will be conducted using a digital hand dynamometer (Vernier Lab). The dynamometer is an isometric force sensor (strain gauge amplifier-based) that measures the force applied to its pressure pads. 5-second maximal voluntary contractions are performed on both of the participant's hands, measured in triplicate. With the subject's back supported and straight, 90 degrees of elbow flexion, and 0 degrees of shoulder flexion, participants hold the dynamometer in the palm and secure a comfortable grip. They are then instructed to squeeze with maximum force which will be measured by the Vernier LabQuest® 2 dynamometer and analyzed using Logger Pro software (Version 3.16.2). Average and peak force values will be utilized for study analysis.

    Performed one time at baseline (visit 1), at day 28 (visit 2), and day 29 (visit 3)

  • Plyometric Push Up (Force Plate)

    The force plate is a platform composed of two force plates that separate the platform into left and a right halves. Each plate contains four force sensors which measure the vertical ground reaction force exerted on the platform. The sensors are connected to a laptop computer and analyzed using the Mechanography GRFP Research Edition® software (version 4.2-b05.53-RES). For the Plyometric Pushup exercise, subjects will perform two sets of two plyometric push-ups on the force plate. Subjects will assume a push up position with one hand centered on each half of the force plate. Each subject will be given an initiation command by the researcher and then perform two maximal effort plyometric push ups on the force plate, pressing themselves as high as possible into the air on each repetition. Subjects will be given 30sec of rest and then repeat once more. Force curves will be analyzed for peak force, rate of force development, and limb symmetry. Results will be averaged and analyzed.

    Performed 2 times (once before bench press and once after bench press) at baseline (visit 1) and at day 28 (visit 2). AT day 29, this will be performed 1 time (visit 3).

  • Bench Press 5 repetition maximum (RM)

    Subjects will be asked to perform a 5 repetition maximum (RM) lift in order to calculate their 1RM for determination of weight needed for the protocol. They will start with a warm-up consisting of the following: 1 set of 8-10 reps of a light weight of their choosing followed by 1-2 sets of 3-5 reps of progressively heavier weights (\~50-70% of self-estimated 1RM). Following a 2-minute rest, subjects will select a weight they feel confident they can do for 5-7 reps but not more than 7 reps (based on warm-up weights). Weight will be increased until the subject is only able to complete 5 reps with good form. This will be their 5RM. For safety, a spotter will always be present for lifts and a set of safety bars will be used as well. Subject's 1RM will be calculated from this 5RM using the Brzycki formula (Macarilla CT, et.al. 2022) 1RM = W / (1.0278 - 0.0278 × R), where W represents the weight lifted in pounds, and R represents the number of repetitions.

    Performed one time at baseline (visit 1) and at day 28 (visit 2).

  • Bench Press Repetitions to Failure

    After calculating the estimated 1RM from the 5RM, subjects will then perform one set of bench press at 70% of the calculated 1RM to failure, followed by three sets to failure at 50 % of 1RM with a two-minute rest between all sets. Total repetitions for each of these sets will be recorded and will be used to determine fatigue and compared to follow-up Visit 2 performance for fatigue resistance. For safety, a spotter will always be present for lifts and a set of safety bars will be used as well.

    Performed one time at baseline (visit 1) and at day 28 (visit 2).

Secondary Outcomes (6)

  • Body Composition (DXA)

    Performed one time at baseline (visit 1) and at day 28 (visit 2).

  • Blood Lactate

    Performed one time at baseline (visit 1) and at day 28 (visit 2).

  • Changes in Psychomotor Vigilance Test

    Performed one time at baseline (visit 1), at day 28 (visit 2), and day 29 (visit 3), once at the beginning of the session and then again at the end of the session.

  • Perceived Recovery Status (PRS) Likert Scale

    Performed at the beginning of Visits 2 and 3 (days 28 and 29) and then as the only outcome for Visit 4 (day 30).

  • Upper Body Soreness Likert Scale

    Performed at the beginning of Visits 2 and 3 (days 28 and 29) and then as the only outcome for Visit 4 (day 30).

  • +1 more secondary outcomes

Other Outcomes (1)

  • Adverse Events

    Continuously throughout the trial, up to 7 months.

Study Arms (4)

Tyrosol and Creatine

EXPERIMENTAL

creatine and tyrosol (3g creatine monohydrate + 500mg tyrosol/day) administered daily

Dietary Supplement: TyrosolDietary Supplement: Creatine

Tyrosol + placebo

EXPERIMENTAL

500mg Tyrosol (administered daily as 1 capsule, containing 500mg/capsule) + 3g of resistant dextrin powder (placebo)

Dietary Supplement: TyrosolDietary Supplement: Resistant Dextrin

Creatine + placebo

ACTIVE COMPARATOR

3g Creatine Monohydrate powder + 500mg Resistant dextrin capsules (as 1 capsule, containing 500mg/capsule) (placebo) administered daily

Dietary Supplement: CreatineDietary Supplement: Resistant Dextrin

placebo + placebo

PLACEBO COMPARATOR

3g of resistant dextrin powder (placebo) + 500mg Resistant dextrin capsules (administered as 1 capsule, containing 500mg/capsule) (placebo) administered daily

Dietary Supplement: Resistant Dextrin

Interventions

TyrosolDIETARY_SUPPLEMENT

phenolic compound found in olive oil

Tyrosol + placeboTyrosol and Creatine
CreatineDIETARY_SUPPLEMENT

chemical produced naturally by the body used to rapidly regenerate ATP

Creatine + placeboTyrosol and Creatine
Resistant DextrinDIETARY_SUPPLEMENT

A type of soluble dietary fiber that is resistant to digestion in the small intestine. It is a byproduct of the starch hydrolysis process, where starch is broken down into smaller chains of glucose molecules

Creatine + placeboTyrosol + placeboplacebo + placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy males or females aged 18-50
  • Currently active (engaged in moderate to vigorous activity at least 2-days per week as defined by the American College of Sports Medicine Guidelines)
  • Estimated VO2 max equal to or greater than the 50th percentile of the population norm for age (assessed via ACSM guidelines, 2014). The VO2 max estimation at screening will be obtained by following a non-exercise regression model validated and described by Bradshaw et al. (2005).
  • Able to read and write in English
  • During the study, agree not to take any other supplements that may increase muscle strength or endurance (e.g. protein formulas, creatine, amino acids, tyrosol or stimulants other than caffeine).
  • Females willing to share days menstrual cycle for testing purposes as shifts in hormone levels may, potentially, affect testing

You may not qualify if:

  • 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 use (within the past 4 weeks) of creatine supplements
  • Current use (within past 3 months) of Tyrosol supplementation
  • Current use of dietary supplements that may enhance mitochondrial function, muscle hypertrophy, or muscle strength (e.g. protein formulas, creatine, amino acids, tyrosol, etc.).
  • Current use of prescription medications that may influence adaptation to exercise (hormone therapies, peptides, etc.)
  • Female subjects who do not test negative on a urine pregnancy test or are lactating.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Applied Science & Performance Institute

Tampa, Florida, 33634, United States

Location

Related Publications (4)

  • Macarilla CT, Sautter NM, Robinson ZP, Juber MC, Hickmott LM, Cerminaro RM, Benitez B, Carzoli JP, Bazyler CD, Zoeller RF, Whitehurst M, Zourdos MC. Accuracy of Predicting One-Repetition Maximum from Submaximal Velocity in The Barbell Back Squat and Bench Press. J Hum Kinet. 2022 Apr 26;82:201-212. doi: 10.2478/hukin-2022-0046. eCollection 2022 Apr.

    PMID: 36196346BACKGROUND
  • Kayihan G, Ozkan A, Koklu Y, Eyuboglu E, Akca F, Koz M, Ersoz G. Comparative analysis of the 1-mile run test evaluation formulae: assessment of aerobic capacity in male law enforcement officers aged 20-23 years. Int J Occup Med Environ Health. 2014 Apr;27(2):165-74. doi: 10.2478/s13382-014-0237-0. Epub 2014 Feb 12.

    PMID: 24519369BACKGROUND
  • Bradshaw DI, George JD, Hyde A, LaMonte MJ, Vehrs PR, Hager RL, Yanowitz FG. An accurate VO2max nonexercise regression model for 18-65-year-old adults. Res Q Exerc Sport. 2005 Dec;76(4):426-32. doi: 10.1080/02701367.2005.10599315.

    PMID: 16739680BACKGROUND
  • Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.

    PMID: 7154893BACKGROUND

MeSH Terms

Interventions

4-hydroxyphenylethanolCreatine

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Eric Sikorski, PhD

    Applied Science and Performance Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2025

First Posted

March 19, 2025

Study Start

March 24, 2025

Primary Completion

August 30, 2025

Study Completion

August 30, 2025

Last Updated

September 11, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations