NCT07756658

Brief Summary

This study will be a randomized, double-blind, placebo-controlled trial. It will be conducted over a 8-week intervention investigating the effects of creatine (5g Creatine monohydrate); placebo control (5g resistant dextrin), and a combination group containing both creatine and tyrosol (5g creatine monohydrate + 150mg tyrosol/day). Endurance, strength, cognition, and fatigue resistance will be examined through repeated strength and endurance 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) mood and cognitive testing; (3) full-body strength testing; (4) 5RM (repetition maximum) bench press, leading to multiple sets of bench press (based on the previous weight) completed to failure; (5) finally, a time to exhaustion endurance test will be conducted followed by (6) repeat cognitive testing. After the 8-week supplementation period (\~56-60 days), all original measures will be repeated as before in the same order (Visit 2). Approximately 24 hours later (Visit 3) participants will complete a questionnaire for muscle soreness remotely, and again at 48 hours post-Visit 2 (visit 4).

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Aug 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 11, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

August 17, 2026

Expected
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2026

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2026

Last Updated

August 11, 2026

Status Verified

August 1, 2026

Enrollment Period

4 months

First QC Date

August 7, 2026

Last Update Submit

August 7, 2026

Conditions

Keywords

tyrosolcreatinemuscle strengthmuscle endurancemuscle sorenessmuscle performancecognitionmood

Outcome Measures

Primary Outcomes (4)

  • 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) and at day 56 (visit 2)

  • Bench Press 5 Repetition Max (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 Ă— 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 56 (visit 2).

  • Bench Press Repetitions to Failure

    After calculating the estimated 1RM from the 5RM, subjects will then perform 4 sets of bench press at 50% of the calculated 1RM to failure 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 56 (visit 2).

  • Muscle/aerobic endurance (Graded Cycling 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.

    Performed one time at baseline (visit 1) and at day 56 (visit 2).

Secondary Outcomes (6)

  • Stroop

    Subjects will complete this on each of the 2 visits (baseline and day 56). Subjects will complete once before exercise protocols and once after in each session.

  • Abbreviated Profile of Mood States Questionnaire

    Subjects will complete once at each visit (baseline and day 56) prior to exercise protocol.

  • Body Composition (DXA)

    Performed one time at baseline (visit 1) and at day 56 (visit 2).

  • Upper Body Muscle Soreness

    Performed at the beginning of Visits 2 (day 56) and then as the only outcome for Visits 3 and 4 (days 57 and 58).

  • Subjective Vitality Scale (SVS)

    Subjects will complete this on each of the 2 visits (baseline and day 56). Subjects will complete once before exercise protocols and once after in each session.

  • +1 more secondary outcomes

Study Arms (3)

Tyrosol and Creatine

EXPERIMENTAL

150mg Tyrosol (administered as 1 capsule, containing 150mg/capsule) + 5g of Creatine Monohydrate powder; taken daily

Dietary Supplement: TyrosolDietary Supplement: Creatine Monohydrate

Creatine + Placebo

EXPERIMENTAL

5g Creatine Monohydrate powder + 150mg Resistant dextrin capsules (administered as 1 capsule, containing 150mg/capsule) (placebo); taken daily

Dietary Supplement: Creatine MonohydrateDietary Supplement: Resistant Dextrin

Placebo + placebo

EXPERIMENTAL

5g of resistant dextrin powder (placebo) + 150mg Resistant dextrin capsules (administered as 1 capsule, containing 150mg/capsule) (placebo); taken daily

Dietary Supplement: Resistant Dextrin

Interventions

TyrosolDIETARY_SUPPLEMENT

phenolic compound found in olive oil

Tyrosol and Creatine
Creatine MonohydrateDIETARY_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 + PlaceboPlacebo + placebo

Eligibility Criteria

Age20 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy males aged 20-55
  • 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 greater than the 40th 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).
  • During the study, subjects will not deviate from their normal daily routine unless it conflicts with study criteria. This includes maintaining their present workout routine and diet, without substantial changes.

You may not qualify if:

  • Known diagnosis of any cardiovascular, metabolic, endocrine, or renal disease
  • Uncontrolled stage II hypertension or higher
  • Recent musculoskeletal injury (\<3-months)
  • Recent orthopaedic surgery (\<12-months)
  • History of or current malignancy
  • Previous gastrointestinal surgery within the past 12 months
  • Regular smoker
  • Regular drinker (\>14 drinks per week)
  • Current use (within the past 5 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Applied Science and Performance Institute

Tampa, Florida, 33634, United States

Location

MeSH Terms

Conditions

Myalgia

Interventions

4-hydroxyphenylethanolCreatine

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesMusculoskeletal PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Eric Sikorski, PhD

    Applied Science and Performance Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric Sikorski, PhD

CONTACT

Gabe Wilson, PhD

CONTACT

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

August 7, 2026

First Posted

August 11, 2026

Study Start (Estimated)

August 17, 2026

Primary Completion (Estimated)

December 17, 2026

Study Completion (Estimated)

December 17, 2026

Last Updated

August 11, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations