Resveratrol + Strength Training for Sarcopenia

(STaR Trial)

Overseen By Danielle E Levitt, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Texas Tech University

Disqualifiers: Cardiovascular disease, Diabetes, Hypertension, others

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 46

Duration: 12 weeks

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a supplement called resveratrol can enhance muscle strength, blood vessel function, and brain health in older adults who engage in strength training. It targets adults aged 60 and above who have not recently participated in regular strength exercises. Participants will take either resveratrol or a placebo (a pill that looks identical but contains no active ingredient) while following a supervised exercise program. This setup allows researchers to determine if resveratrol affects how muscles respond to exercise. The trial is ideal for those who are lightly active and not currently taking resveratrol. As an unphased study, it offers a unique opportunity to contribute to scientific understanding and potentially improve personal health outcomes.

Will I have to stop taking my current medications?

The trial requires that your medication regimen has been stable for the past 3 months and that you have no plans to change it during the study. So, you should not stop taking your current medications if they have been stable.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that resveratrol is generally safe for people. In a twelve-week study, participants who took resveratrol in doses of 300 mg and 1000 mg daily experienced no negative effects on their blood health, indicating that resveratrol is well-tolerated even at higher doses. Known for its antioxidant and anti-inflammatory benefits, resveratrol can support overall health. Another study found that resveratrol did not cause kidney problems in participants with colorectal cancer, further demonstrating its safety. Overall, these findings suggest that resveratrol is safe for use in clinical trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about resveratrol for sarcopenia because it offers a novel approach that could complement existing treatments like exercise and nutritional supplements. Resveratrol is a natural compound found in red wine and grapes, known for its antioxidant properties, which may help reduce inflammation and support muscle health. Unlike typical treatments that primarily focus on protein intake and physical activity, resveratrol might enhance the body's ability to build and maintain muscle by targeting cellular pathways involved in muscle aging and regeneration. This potential to work at a cellular level makes it a promising addition to current sarcopenia management strategies.

What evidence suggests that resveratrol might be an effective treatment for sarcopenia?

Research shows that resveratrol, a substance found in grapes and berries, might help combat sarcopenia, the loss of muscle mass and strength with age. Studies have found that resveratrol can prevent muscle loss and enhance muscle strength in animals. It appears to work by slowing muscle breakdown and protecting muscle cells from damage. Evidence also suggests that resveratrol can improve blood flow and reduce inflammation, potentially supporting muscle health. Although most information comes from animal studies, these results are promising for potential benefits in humans. In this trial, participants will receive either resveratrol or a placebo, along with a structured resistance training program, to evaluate its effects on muscle health in humans. ^{6 7 8 9 10}

Who Is on the Research Team?

Danielle E Levitt, PhD

Principal Investigator

Texas Tech University

Are You a Good Fit for This Trial?

This trial is for adults aged 60 and older who haven't done resistance training in the last 6 months, aren't taking resveratrol supplements, have stable medication and lifestyle habits with minimal activity levels (less than an hour of structured exercise per week).

Inclusion Criteria

Minimally active (less than 1 hour of structured exercise/week other than walking)

I am not taking resveratrol supplements.

I am 60 years old or older.

Exclusion Criteria

I don't have health issues that make exercise risky for me.

Cannabis or nicotine use

Consume more than 7 alcohol-containing beverages per week

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pre-testing

Participants are familiarized with procedures and undergo pre-testing

1 week

3 visits (in-person)

Treatment

Participants undergo strength training 3x/week for two 6-week blocks with resveratrol or placebo supplementation

12 weeks

36 visits (in-person)

Testing

Testing conducted after each 6-week block of strength training

2 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Resveratrol

Trial Overview

The study tests if resveratrol supplements can boost muscle strength gains from resistance training in seniors. It also looks at how this might affect blood vessel and brain health by studying extracellular vesicles.

How Is the Trial Designed?

Group I: Resveratrol (RSV) group Experimental Treatment 2 Interventions

Participants will be randomized to consume resveratrol (500 mg) daily for 14 weeks (two 6-week blocks of resistance training \[supervised, full-body, 3 days/week\] + one testing week \[3 days\] following each block) after the pre-testing period. Participants will be provided with 7 days' worth of supplements at a time in pre-filled pill boxes. Pill boxes will be refilled weekly and adherence monitored.

Group II: Placebo Placebo Group 2 Interventions

Participants will be randomized to consume placebo capsules (cellulose, visually identical to resveratrol capsules) daily for 14 weeks (two 6-week blocks of resistance training \[supervised, full-body, 3 days/week\] + one testing week \[3 days\] following each block) after the pre-testing period. Participants will be provided with 7 days' worth of supplements at a time in pre-filled pill boxes. Pill boxes will be refilled weekly and adherence monitored.

Who Is Running the Clinical Trial?

Texas Tech University

Lead Sponsor

Trials

89

Recruited

10,300+

National Strength and Conditioning Association Foundation

Collaborator

Trials

4

Recruited

110+

National Strength and Conditioning Association

Collaborator

Published Research Related to This Trial

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]

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]

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]

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]

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As SRT501 was proven to be safe in a phase 2 clinical trial, and it did not cause any nephrotoxicity in a phase 1 study for colorectal cancer ...