NCT06723119 · University of Central Florida
Effect of Resveratrol Supplementation on Exercise Performance and Recovery
What this study is about
To examine the effects of once daily supplementation with 500mg VeriSperse® resveratrol (VRES) for 17 days on muscle function, delayed onset muscle soreness, systemic concentrations of muscular damage markers and markers of oxidative stress in resistance trained young adult males following a damaging isoinertial squat protocol (ISP).
View original scientific description
To examine the effects of once daily supplementation with 500mg VeriSperse® resveratrol (VRES) for 17 days on muscle function, delayed onset muscle soreness, systemic concentrations of muscular damage markers and markers of oxidative stress in resistance trained young adult males following a damaging isoinertial squat protocol (ISP).
Interventions
OTHER
Resveratrol (VRES) 500 mg oral once daily.
Resveratrol supplement will be provided in capsule form within a distinctly labeled bottle. Participants will be instructed to consume 2 capsules (500mg) of their assigned supplement with at least 8oz of water immediately upon waking for 17 days.
OTHER
Placebo 500 mg oral once daily.
Placebo will be supplement will be provided in capsule form within a distinctly labeled bottle. Participants will be instructed to consume 2 capsules (500mg) of their assigned supplement with at least 8oz of water immediately upon waking for 17 days.
Primary outcome measures
Venous Blood Sample Collection - Creatine Kinase
Time frame: Visit 2 & visits 6-13 approx=8 weeks
Blood samples will be obtained at V2, PRE-, IP, 24H, 48H, and 72H using a 21-gauge vacutainer or 23-gauge butterfly needle from a superficial forearm vein. Up to 2 unsuccessful attempts in one arm, and with permission, a third attempt in the opposite arm, will be made. Three failed attempts will terminate the draw. Issues with blood collection devices will not remove participants from the study. All draws will follow aseptic conditions, with skin disinfected before insertion and the puncture site bandaged afterward. A total of 8mL of blood (slightly less than 2 tsp) will be collected at each time point (V2 \& V6-V13) in one 4mL BD Vacutainer™ SST. Serum tubes will be inverted, clotted at room temperature for 30 minutes, centrifuged for 10 minutes at 4000rpm, aliquoted, and frozen at -80°C within one hour. Serum will be used to determine creatine kinase (CK) concentrations, presented as U/L.
Venous Blood Sample Collection - C-Reactive protein
Time frame: Visit 2 & visits 6-13 approx=8 weeks
Blood samples at V2, PRE-, IP, 24H, 48H, and 72H will be obtained using a 21-gauge vacutainer or 23-gauge butterfly needle from a superficial forearm vein. A maximum of 2 unsuccessful attempts per arm will be allowed, with a third attempt permitted in the opposite arm if agreed upon. Three failed attempts will terminate the draw. Issues with blood collection devices will not disqualify participants from the study. All blood draws will follow aseptic conditions, with the skin disinfected before insertion and the puncture site covered with a bandage. A total of 8mL of blood (slightly less than 2 tsp) will be collected at each time point (V2 \& V6-V13) in one 4mL BD Vacutainer™ SST. Serum tubes will be inverted, clotted at room temperature for 30 minutes, centrifuged for 10 minutes at 4000rpm, aliquoted, and frozen at -80°C within one hour of collection. Serum will be used to determine C-reactive protein (CRP) concentrations. and presented at U/L.
Venous Blood Sample Collection - CBC
Time frame: Visit 2 & visits 6-13 approx=8 weeks
Blood samples at V2, PRE-, IP, 24H, 48H, and 72H will be obtained using a 21-gauge vacutainer needle or 23-gauge butterfly needle from a superficial forearm vein. A maximum of two unsuccessful attempts per arm will be allowed, with a third attempt in the opposite arm if agreed upon. Three failed attempts will terminate the blood draw. Issues with blood collection devices will not disqualify participants from continuing the study. All blood draws will follow aseptic procedures, with the skin disinfected before insertion and the puncture site covered with a bandage. A total of 8mL of blood (slightly less than 2 tsp) will be collected at each time point (V2 \& V6-V13) in one 4mL K2EDTA plasma tube (EDTA). EDTA samples will be analyzed same day using a Sysmex XN-450 Automated Hematology Analyzer, and used to measure hematocrit, hemoglobin, MCV, MCH, MCHC, total and differential blood cell counts, and platelets in-house at the Cellular Exercise Physiology Laboratory.
Flow Mediated Dilation (FMD)
Time frame: Visit 2 & visits 6-13 approx=8 weeks
Subjects will rest in a quiet, dimly lit laboratory in a semi-recumbent position for 15 minutes before testing. Automated sphygmomanometry will measure resting systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate (HR) on the left arm, with mean arterial pressure (MAP) calculated. Brachial artery diameter and blood velocity will be assessed using duplex Doppler ultrasound (GE Logiq P9) with a 5-MHz transducer. A tourniquet cuff will be placed around the right forearm to induce reactive hyperemia. Baseline measurements will be recorded for 2 minutes, followed by 5 minutes of arterial occlusion at 240 mmHg, and 3 minutes post-deflation. Ultrasound settings will remain consistent, with scans performed by the same technician and saved via video capture software (Snagit). Offline analysis will use FMD Studio, with parameters calculated via custom macros in Microsoft Excel. FMD will be assessed at V2, and PRE.
Ultrasound Measurement (MT and EI)
Time frame: Visit 2 & visits 6-13 approx=8 weeks
Rectus femoris (RF), vastus medialis (VM), and vastus lateralis (VL) muscle thickness (MT) and echo intensity (EI) will be assessed on the right leg using B-mode ultrasound (GE Logiq, General Electric Medical Systems, Milwaukee, WI, USA) with a linear array probe (L4-12t, 4.2-13.0 MHz). Measurements will be performed at 12 MHz, gain of 50 dB, depth of 5 cm, and dynamic range of 72. A water-soluble gel will enhance acoustic coupling. Three images of each muscle will be captured in the sagittal plane. RF images will be taken midway between the superior patella and inguinal fold, VM images 3 inches proximal to the medial femoral epicondyle, and VL images midway between the greater trochanter and superior patella. Images will be analyzed using ImageJ software (v1.53v, NIH, Bethesda, MD) following Girts et al. (41). MT and EI will be assessed at PRE, IP, 24H, 48H, and 72H for each experimental trial.
Active Range of Motion (AROM)
Time frame: Visit 2 & visits 6-13 approx=8 weeks
AROM will be assessed following the standardized warm-up while participants are in a prone position on a padded testing table with their legs fully supported. A handheld goniometer will be used to assess AROM of the right knee. The goniometer will be anchored at the lateral epicondyle of the femur with the stationary arm in line with the greater trochanter of the femur and the movement arm aligned with the lateral malleolus of the ankle. Participants will be instructed to move the knee from maximal full extension throughout the range of motion to maximum full flexion holding each end point for two seconds. The average of two consecutive measurements will be used to determine AROM. AROM will be assessed at PRE, IP, 24H, 48H, and 72H during each experimental trial.
Pain Pressure Threshold
Time frame: Visit 2 & visits 6-13 approx=8 weeks
PPT will be assessed immediately following the AROM assessment while the participants sat on the end of padded table with their upper legs supported and their lower legs hanging freely. Using a handheld 15kg dolorimeter with a 1 cm rubber tip, pressure will be applied to the RF, VM, and VL at locations identical to that of the ultrasound assessments increasing at a rate of 1 kg/s until participants first report feeling pain, at which point the algometer will be removed from the skin. PPT will be assessed once at each sight before a second measure of PPT at each location is acquired. The algometer value at the onset of pain will be recorded and the average of two measures with will be used to denote PPT. PPT will be assessed at PRE, IP, 24H, 48H, and 72H during each experimental trial.
Perceived Recovery Scale (PRS)
Time frame: Visit 2 & visits 6-13 approx=8 weeks
PRS will be assessed as a total feeling of recovery in the lower extremities (waist down) and be performed while the participant is standing at a knee angle of 140 degrees immediately prior to MS testing. Participants will be asked to rank their level of recovery on a 100mm VAS ranging from 0 to 100, with 0 being not at all recovered and 100 being very well recovered. PRS will be assessed at PRE, IP, 24H, 48H, and 72H during each experimental trial.
Muscle Soreness (MS)
Time frame: Visit 2 & visits 6-13 approx=8 weeks
MS will be assessed as a total feeling of soreness in the lower extremities (waist down) and be performed while the participant is standing at a knee angle of 140 degrees immediately prior to MVIC testing. Participants will be asked to rank their level of MS of their entire lower extremities on a 100mm VAS ranging from 0 to 100, with 0 being no pain at all and 100 being the most pain imaginable. MS will be assessed at PRE, IP, 24H, 48H, and 72H during each experimental trial.
Maximal Voluntary Isometric Contraction (MVIC) and Rate of Force development (RFD)
Time frame: Visit 2 & visits 6-13 approx=8 weeks
MVIC assessments will be conducted using a specialized isometric squat rack with an immovable bar. Bar height, set during V2 and standardized for all subsequent assessments, will align participants to a knee angle of 140 degrees. Each MVIC session will include 3 x 5s maximal isometric contractions, where participants will drive upward against the bar by extending their knees and hips, mimicking a high bar back squat. Contractions will be initiated by a verbal prompt, with consistent encouragement provided throughout. One minute of rest will be given between contractions. The highest peak force recorded will represent the participant's MVIC, from which rate of force development (RFD) will be determined at 0-250ms from contraction onset. MVIC and RFD will be assessed at PRE, IP, 24H, 48H, and 72H during each trial.
Vertical Jump Protocol (VJ)
Time frame: Visit 2 & visits 6-13 approx=8 weeks
Vertical countermovement jumps will be assessed on the same force plates utilized for the MVIC. Participants will undergo 3 vertical jump trials with 1 minute rest between. Participants will be instructed to jump as high as possible with their hands on their hips. The highest value achieved in the three trials will be used to denote the participant's maximal vertical jump height. VJ will be assessed at PRE, IP, 24H, 48H, and 72H during each experimental trial.
Isoinertial Squat Protocol (ISP)
Time frame: Visit 2 & visits 6-13 approx=8 weeks
The ISP will be conducted using the Desmotec isoinertial training device (D11 evo, Desmotec, Biella, Italy) with force and power output measured via underfoot force plates. Participants will stand in a position mimicking a traditional back squat, arms crossed to opposite shoulders, and maintain this posture throughout. They will be strapped into the device with cable tension set to 15kg using a handheld scale (ROMECH, Paisley, UK) for consistency. Cable length will be recorded during V2 and standardized for subsequent assessments. The ISP consists of 6 sets of 10 maximal repetitions at .067kg/mm² isoinertial resistance, preceded by two low-effort "free repetitions" to establish rhythm. Participants will give maximal effort during the concentric phase, reaching full extension, and delay braking during the eccentric phase until the last moment, using a horizontal rope as a depth marker (\~90° knee angle). Concentric and eccentric force and power will be averaged per set.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- • Male between the ages of 18-40 years old
- Healthy, and ready for physical activity as determined by the PAR-Q+, and MHQ.
- Participants will be required to be recreationally active (defined according to ACSM standards of at least 150 minutes exercise per week).
- Participants will be required to have been actively resistance training for a minimum of 6 months as defined by 3 resistance training sessions per week with at least one lower body session.
- Participants must be willing to abstain from the consumption of bananas of non-steroidal anti-inflammatory drugs (NSAIDs) for the duration of their enrollment in study.
- Participants must be willing to abstain from dietary supplementation that are viewed by study investigators to confound the outcomes of the study (e.g., Creatine). Those currently supplementing must be willing to undergo a 28-day washout prior to beginning study procedures.
- Participants must be consuming \<300 mg·day-1 (Equivalent to 3 cups of coffee per day or 2 16oz cans of Redbull) and willing to keep their caffeine consumption consistent throughout the duration of the study.
- Participants will be required to have access to the online MyFitnessPal application either via cellphone or computer and be willing to download and maintain the application for the duration of the study.
- Free from previous or current lower body injuries that are viewed by the investigators to potentially limit ability of the participant to perform the assessments.
- Willing to abstain from lower body resistance training for the 14 days preceding ET1 and ET2
Exclusion criteria
- • Individual does not provide consent to participate in this study.
- Inability to perform physical exercise (determined by MHQ, and PAR Q+). That is Answering "Yes" to any question on the PAR-Q +, or having a pre-existing condition such as musculoskeletal injury, back pain, chronic pain etc. that the investigative team perceives will prevent a participant from safely completing the protocol.
- Not currently participating in at least 150 minutes of physical activity per week.
- Not currently resistance trained (as defined within the inclusion criteria)
- Currently taking any performance-enhancing drug (determined from health and activity questionnaire)
- Currently taking a nutritional supplement known to improve physical performance and not willing refrain form the consumption of the supplement for at least 28-days prior to beginning study procedures.
- Regularly taking any type of prescription or over-the-counter medication deemed to affect performance, or having any chronic illnesses, which require medical care.
- Have used nicotine or tobacco at any time within the last three months.
- Report consuming bananas or NSAIDS at any time during your enrollment in the study.
- Report daily caffeine consumption \>300 mg·day-1
- Report any lower extremity muscle soreness for visits ET1 and ET2
- Previous or current lower body injuries viewed by the investigators to potentially limit the ability of the participant to perform the assessments.
- Inability or unwillingness to consume the provided standardized snacks and meals in their entirety.
- Inability or unwillingness to adhere to the diet restrictions of the study.
- Have a food allergy to either of the two provided energy bars.
- Inability or unwillingness to report all food and beverage consumption during the two 5-day dietary log periods.
Where
- Orlando, Florida
Collaborators
Gencor Pacific Group
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 9, 2024 · Source of record for eligibility and locations