Resveratrol for Exercise Performance and Recovery

Recruiting in Palo Alto (17 mi)

Age: 18 - 65

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Central Florida

Must not be taking: Performance-enhancing drugs, NSAIDs

Disqualifiers: Musculoskeletal injury, Chronic pain, others

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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).

Will I have to stop taking my current medications?

The trial requires participants to stop taking any performance-enhancing drugs and nutritional supplements known to improve physical performance for at least 28 days before starting the study. Regular use of prescription or over-the-counter medications that affect performance is also not allowed.

What data supports the effectiveness of the drug Resveratrol for exercise performance and recovery?

Research shows that trans-resveratrol, a component of Resveratrol, has anti-inflammatory and antioxidant properties, which may help in reducing inflammation and oxidative stress, potentially aiding in exercise recovery. ^{1 2 3 4 5}

Is resveratrol generally safe for humans?

Resveratrol, found in red wine and other foods, has been studied for its potential health benefits, including anti-inflammatory and antioxidant effects. While specific safety data for humans is limited, it is generally considered safe in moderate amounts, as it is naturally present in foods like grapes and peanuts. ^{1 2 3 6 7}

How does the drug resveratrol differ from other treatments for exercise performance and recovery?

Resveratrol is unique because it is a natural compound found in red wine that may improve exercise endurance and muscle metabolism by activating sirtuins, which are proteins involved in cellular health. Unlike other treatments, it also has antioxidant and anti-inflammatory properties, potentially offering additional health benefits. ^{1 2 8 9 10}

Research Team

Eligibility Criteria

This trial is for young adult males who regularly engage in resistance training. They must be healthy and willing to take a daily supplement or placebo for 17 days, then perform specific squat exercises.

Inclusion Criteria

Recreationally active according to ACSM standards of at least 150 minutes exercise per week

Healthy and ready for physical activity as determined by the PAR-Q+ and MHQ

I am a man aged between 18 and 40.

Exclusion Criteria

Individual does not provide consent to participate in the study

Not currently participating in at least 150 minutes of physical activity per week

I am unable to perform physical exercises.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive once daily supplementation with 500mg VeriSperse® resveratrol or placebo for 17 days

2.5 weeks

13 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Resveratrol (Other)

Trial Overview The study tests if taking 500 mg of VeriSperse® resveratrol (VRES) daily improves muscle function, reduces soreness, and affects markers of muscle damage and oxidative stress after intense leg workouts compared to a placebo.

Participant Groups

Group I: Resveratrol Supplementation Active Control 1 Intervention

Once daily (immediately upon waking) supplementation with 500mg (2 capsules) VeriSperse® resveratrol (VRES) for 17 days

Group II: Placebo Placebo Group 1 Intervention

Once daily (immediately upon waking) supplementation with 500mg (2 capsules) Placebo (maltodextrin) for 17 days

Resveratrol is already approved in Canada for the following indications:

Approved in Canada as Resveratrol for:

• Dietary supplement for cardiovascular health and antioxidant properties

Who Is Running the Clinical Trial?

University of Central Florida

Lead Sponsor

Trials

101

Recruited

1,191,000+

Dr. Michael Pape

University of Central Florida

Chief Executive Officer since 2015

PhD in Biochemistry from Purdue University, MBA from the University of Chicago Booth School of Business

Dr. James J. Hickman

University of Central Florida

Chief Medical Officer since 2020

MD from University of Central Florida College of Medicine

Gencor Pacific Group

Industry Sponsor

Trials

4

Recruited

300+

Findings from Research

Trans-resveratrol (t-RESV), found in grape skins and red wine, shows significant anti-inflammatory and anticarcinogenic properties in various experimental models, highlighting its potential as a therapeutic agent.

The cis isomer of resveratrol (c-RESV) is less studied and not commercially available, leading to a gap in understanding its pharmacological effects compared to the well-researched t-RESV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative studies of the antioxidant effects of cis- and trans-resveratrol. Orallo, F.[2022]

A new method was developed to accurately measure resveratrol levels in animal and human samples, showing high specificity and recovery rates (96.8%) with a low detection limit of 50 ng/ml.

The study demonstrated that resveratrol can be effectively incorporated into blood cells and lipoproteins, suggesting its potential role in inhibiting lipoprotein oxidation and platelet activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gas chromatographic analysis of resveratrol in plasma, lipoproteins and cells after in vitro incubations. Blache, D., Rustan, I., Durand, P., et al.[2019]

Cis-resveratrol significantly reduces collagen-induced platelet aggregation in vitro, with a decrease of 43.5% at a concentration of 1 x 10(-5) M, indicating its potential as an anti-aggregating agent.

Trans-resveratrol also shows anti-aggregating effects but is slightly less effective than cis-resveratrol, suggesting that both isomers should be considered when evaluating resveratrol's overall activity in biological systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antiplatelet activity of cis-resveratrol. Bertelli, AA., Giovannini, L., Bernini, W., et al.[2018]

Trans-resveratrol at a dosage of 2000 mg twice daily was found to be well tolerated in a study of eight healthy subjects, although diarrhea was a common side effect in six participants.

The study revealed that taking trans-resveratrol with a standard breakfast maximizes its absorption, while a high-fat meal significantly reduces its plasma concentration, indicating the importance of meal composition on its pharmacokinetics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Steady-State pharmacokinetics and tolerability of trans-resveratrol 2000 mg twice daily with food, quercetin and alcohol (ethanol) in healthy human subjects. la Porte, C., Voduc, N., Zhang, G., et al.[2021]

Trans-resveratrol is primarily metabolized into two main forms: trans-resveratrol-3-O-glucuronide and trans-resveratrol-3-sulfate, which were found abundantly in rat urine and mouse serum, indicating effective metabolism in the body.

The study found virtually no unconjugated resveratrol in urine or serum samples, suggesting that previous in vitro studies using only unconjugated resveratrol may not accurately reflect its metabolism and effects in living organisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human, rat, and mouse metabolism of resveratrol. Yu, C., Shin, YG., Chow, A., et al.[2019]

Synthetic cis-polymethoxystilbenes, derived from the biologically inactive cis-resveratrol, showed potent anti-cancer effects against metastatic B16 F10 melanoma cells, with an IC50 of less than 10 μM, indicating strong efficacy.

These compounds inhibited cell motility and proliferation more effectively than both cis- and trans-resveratrol, suggesting they could be promising candidates for chemotherapy in treating metastatic melanoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-tumor properties of cis-resveratrol methylated analogs in metastatic mouse melanoma cells. Morris, VL., Toseef, T., Nazumudeen, FB., et al.[2018]

In a clinical trial involving 66 older adults with peripheral artery disease (PAD), resveratrol at a dose of 125 mg/day showed a slight improvement in 6-minute walk distance compared to placebo, but the results were not statistically significant (P=0.07).

The higher dose of 500 mg/day of resveratrol did not improve walking performance and was similar to the placebo group, indicating that resveratrol may not be an effective treatment for enhancing walking ability in older patients with PAD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Resveratrol on Walking Performance in Older People With Peripheral Artery Disease: The RESTORE Randomized Clinical Trial. McDermott, MM., Leeuwenburgh, C., Guralnik, JM., et al.[2019]

This study analyzed the content of trans- and cis-resveratrol in 18 commercial Serbian wines, revealing that trans-resveratrol was present in all but one sample, with concentrations ranging from 0.11 to 1.69 mg/L.

Cis-resveratrol was found in 12 out of the 18 wines, with levels between 0.12 and 1.49 mg/L, indicating that Serbian wines contain significant amounts of these beneficial compounds, which are associated with various health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determination of trans- and cis-resveratrol in Serbian commercial wines. Cvejic, JM., Djekic, SV., Petrovic, AV., et al.[2019]

Red wines contain significantly higher levels of beneficial compounds like resveratrol and piceid, averaging 4.37 mg/liter, compared to only 0.68 mg/liter in white wines, suggesting a stronger protective effect against cardiovascular disease from red wine consumption.

The study analyzed 42 wines from various regions in Japan, confirming that specific grape varieties, such as Pinot noir, Merlot, and Zweigeltrebe, have particularly high resveratrol content, which may contribute to their health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contents of resveratrol, piceid, and their isomers in commercially available wines made from grapes cultivated in Japan. Sato, M., Suzuki, Y., Okuda, T., et al.[2019]

References

1. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Comparative studies of the antioxidant effects of cis- and trans-resveratrol. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Gas chromatographic analysis of resveratrol in plasma, lipoproteins and cells after in vitro incubations. [2019]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Antiplatelet activity of cis-resveratrol. [2018]

4. Germany pubmed.ncbi.nlm.nih.gov

Bioavailability of trans-resveratrol from red wine in humans. [2018]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Steady-State pharmacokinetics and tolerability of trans-resveratrol 2000 mg twice daily with food, quercetin and alcohol (ethanol) in healthy human subjects. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Human, rat, and mouse metabolism of resveratrol. [2019]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Anti-tumor properties of cis-resveratrol methylated analogs in metastatic mouse melanoma cells. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Effect of Resveratrol on Walking Performance in Older People With Peripheral Artery Disease: The RESTORE Randomized Clinical Trial. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Determination of trans- and cis-resveratrol in Serbian commercial wines. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Contents of resveratrol, piceid, and their isomers in commercially available wines made from grapes cultivated in Japan. [2019]