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

Trial Summary

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.

What evidence supports the effectiveness of the treatment Resveratrol for sarcopenia?

Resveratrol, a compound found in red wine, has shown various health benefits, including anti-inflammatory and antioxidant effects, which may help in conditions like sarcopenia (muscle loss with aging). It has also demonstrated anticancer and cardioprotective properties, suggesting its potential in improving overall health and possibly aiding in muscle maintenance. ^{1 2 3 4 5}

Is resveratrol safe for human use?

Safety studies on high-purity trans-resveratrol, a compound found in grapes, show it is generally well tolerated and non-toxic in animals, with no adverse effects observed at high doses. It was non-irritating to skin and eyes, non-sensitizing, and did not cause any harmful effects in reproductive studies. ^{2 6 7 8 9}

How does the treatment of Resveratrol + Strength Training for Sarcopenia differ from other treatments?

This treatment is unique because it combines resveratrol, a compound found in red wine that may improve muscle function and reduce oxidative stress, with strength training to potentially enhance muscle mass and function in older adults. Unlike other treatments that may focus solely on exercise or dietary supplements, this approach integrates both to target sarcopenia more comprehensively. ^{10 11 12 13 14}

What is the purpose of this trial?

The main goal of this study is to find out if supplementing with resveratrol improves skeletal muscle adaptations to strengthening exercise (resistance training or strength training) in adults age 60+, and to determine whether circulating vehicles of inter-organ communication (extracellular vesicles) and their cargo might help explain those responses. The investigators will also examine whether resveratrol supplementation improves blood vessel function and cognitive function (brain health) in response to strength training.

Research Team

Danielle E Levitt, PhD

Principal Investigator

Texas Tech University

Eligibility Criteria

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

I am 60 years old or older.

I am not taking resveratrol supplements.

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

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

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

Treatment Details

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.

Participant Groups

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

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Cytotoxic and biochemical effects of 3,3',4,4',5,5'-hexahydroxystilbene, a novel resveratrol analog in HL-60 human promyelocytic leukemia cells. [2018]

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

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

3. England pubmed.ncbi.nlm.nih.gov

Collisionally induced fragmentation of [M-H](-) species of resveratrol and piceatannol investigated by deuterium labelling and accurate mass measurements. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Resveratrol, ε-Viniferin, and Vitisin B from Vine: Comparison of Their In Vitro Antioxidant Activities and Study of Their Interactions. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Anti-aging properties of resveratrol: review and report of a potent new antioxidant skin care formulation. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

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

7. Switzerland pubmed.ncbi.nlm.nih.gov

Antiplatelet activity of cis-resveratrol. [2018]

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

Ultraviolet irradiation of trans-resveratrol and HPLC determination of trans-resveratrol and cis-resveratrol in Romanian red wines. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Safety studies conducted on high-purity trans-resveratrol in experimental animals. [2018]

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

Short-term caloric restriction, resveratrol, or combined treatment regimens initiated in late-life alter mitochondrial protein expression profiles in a fiber-type specific manner in aged animals. [2021]

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

Long-term supplementation with resveratrol alleviates oxidative stress but does not attenuate sarcopenia in aged mice. [2022]

12. 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]

13. England pubmed.ncbi.nlm.nih.gov

Effect of lifelong resveratrol supplementation and exercise training on skeletal muscle oxidative capacity in aging mice; impact of PGC-1α. [2022]

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

Effects of resveratrol on the recovery of muscle mass following disuse in the plantaris muscle of aged rats. [2021]