Clinical trial NCT06883292: The Effects of Tyrosol and Creatine on Endurance, Strength, and Fatigue Resistance in Healthy Adults
Official title: The Effects of Tyrosol and Creatine on Endurance, Strength, and Fatigue Resistance in Healthy Adults: a Randomized, Double-Blind, Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tyrosol
Creatine
Endurance Performance
Cognition
Keywords: tyrosol
creatine
muscle strength
muscle endurance
muscle recovery
muscle performance
reaction time
Lead sponsor: Applied Science & Performance Institute
Sponsor class: INDUSTRY
First posted: 2025-03-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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).

Detailed description: This study will be a randomized, double-blind, placebo-controlled trial. It will be conducted over a 4-week intervention investigating the effects of tyrosol (500mg Tyrosol); placebo control (3g resistant dextrin), and two additional groups including creatine alone (3g creatine monohydrate) and a combination group containing both creatine and tyrosol (3g creatine monohydrate + 500mg tyrosol/day). Endurance, strength, and fatigue resistance will be examined through repeated strength and endurance testing as described below.

On day one (Visit 1) of testing, after a minimum 8-hour overnight fast, subjects will proceed with a series of tests in the following successive order: (1) DXA for body composition followed by consumption of a standardized food bar snack and at least a 15-minute break after the snack. After the 15-minute break, subjects will proceed with the following tests: (2) Psychomotor Vigilance Test (PVT); (3) full-body strength measurement using a computerized mid-thigh pull; (4) strength via grip strength on both hands, tested in triplicate using a dynamometer; (5) 2 sets of 2 plyometric push-ups (with the average of each set used as the outcome metric) on a dual ground-reaction force plate, with a 30 seconds rest between sets; (6 \& 7) Resting blood lactate will be measured in duplicate followed by determination of the subject's 5RM (repetition maximum) bench press, which will be used to calculate their 1RM. Subjects will then perform one set of bench 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. After completion of the last set, another blood lactate reading will be taken (in duplicate) and recorded; (8) subjects will then perform the plyometric push-up protocol one more time to assess the immediate effects of fatigue; (9) subjects will then complete a 1 mile time trial run completed as fast as possible. Rate of Perceived Exertion (RPE) will also be collected during the 1 mile run using Borg RPE scale (Borg, 1982).VO2 max will be estimated from the 1 mile run time, age, gender and BMI, using equations described by Kayihan et al. (2014). Finally, the subjects will repeat the PVT at the end of the session.

After the 4 week supplementation period (approximately 28+6 days), all baseline measures will be repeated in the fasted state, in the same successive order (Visit 2). Approximately 24 hours later (Visit 3) subjects will then repeat all physical testing procedures except tests 1, 6, 7, and 8 (which would exclude DXA, Blood Lactate, Bench Press 5RM and sets to failure, and the second plyometric push-up test) to assess physical recovery between groups. Additionally, likert scales for soreness and perceived recovery will be completed as the first outcome measure just prior to the first PVT exam, at Visit 2 and 3, and again on its own as the only testing event performed at 48 hours post-bout (visit 4). Finally, on post-testing days (Visit 2 and 3), a full dosage of the study treatment will be taken with water, as well as a standardized food bar snack; and will be administered on-site by staff. On visit 2, this supplement will be taken just after completion of the DXA (prior to Likert and PVT); on Visit 3, the treatment will be taken prior to the start of Likert scales and PVT testing. The subjects will wait for at least 15 minutes after the snack and treatment to begin the remaining tests.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Mid Thigh Pull
timeFrame: Performed one time at baseline (visit 1), at day 28 (visit 2), and day 29 (visit 3)
measure: 1-mile run
timeFrame: Performed one time at baseline (visit 1), at day 28 (visit 2), and day 29 (visit 3)
measure: Rate of Perceived Exertion (RPE)
timeFrame: 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)
measure: Grip Strength
timeFrame: Performed one time at baseline (visit 1), at day 28 (visit 2), and day 29 (visit 3)
measure: Plyometric Push Up (Force Plate)
timeFrame: 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).
measure: Bench Press 5 repetition maximum (RM)
timeFrame: Performed one time at baseline (visit 1) and at day 28 (visit 2).
measure: Bench Press Repetitions to Failure
timeFrame: Performed one time at baseline (visit 1) and at day 28 (visit 2).
Secondary outcomes:
measure: Body Composition (DXA)
timeFrame: Performed one time at baseline (visit 1) and at day 28 (visit 2).
measure: Blood Lactate
timeFrame: Performed one time at baseline (visit 1) and at day 28 (visit 2).
measure: Changes in Psychomotor Vigilance Test
timeFrame: 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.
measure: Perceived Recovery Status (PRS) Likert Scale
timeFrame: Performed at the beginning of Visits 2 and 3 (days 28 and 29) and then as the only outcome for Visit 4 (day 30).
measure: Upper Body Soreness Likert Scale
timeFrame: Performed at the beginning of Visits 2 and 3 (days 28 and 29) and then as the only outcome for Visit 4 (day 30).
measure: Estimated VO2max
timeFrame: Performed one time at baseline (visit 1), at day 28 (visit 2), and day 29 (visit 3).
Other outcomes:
measure: Adverse Events
timeFrame: Continuously throughout the trial, up to 7 months.
Locations:
city: Tampa
country: United States
facility: Applied Science & Performance Institute
state: Florida
Study officials:
affiliation: Applied Science and Performance Institute
name: Eric Sikorski, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.