Strength Training and Resveratrol (STaR)

Resveratrol-mediated Changes in Extracellular Vesicle microRNA Cargo as a Novel Contributor to Resistance Training-induced Skeletal Muscle Adaptations in Older Adults

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.

Study Overview

• Status: Recruiting
• Conditions: Sarcopenia; Anabolic Resistance
• Intervention / Treatment: Behavioral: Resistance training; Dietary supplement: Resveratrol 500 mg oral once daily.; Dietary supplement: Placebo

Detailed Description

After screening and providing informed consent, participants (healthy older adults, age 60+, minimally active) will be familiarized with the procedures and undergo pre-testing. After pre-testing, participants will be assigned to supplement with resveratrol or placebo (double-blinded) daily while undergoing a strength training intervention. Strength training will be performed 3x/week for two 6-week blocks, and each visit will be supervised by a member of the study team. An additional week of testing will follow each of the two 6-week blocks.

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Danielle E Levitt, PhD; Phone Number: 806-834-1830; Email: danielle.levitt@ttu.edu
• Study Contact Backup: Name: Jacob A Mota, PhD; Phone Number: 806-834-8772; Email: jacob.mota@ttu.edu

Study Locations

• United States
  • Texas
    • Lubbock, Texas, United States, 79409
      • Recruiting
      • Department of Kinesiology & Sport Management, Texas Tech University
      • Contact: Danielle E Levitt, PhD; Phone Number: 806-834-1830; Email: danielle.levitt@ttu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age 60+
• Minimally active (less than 1 hour of structured exercise/week other than walking)
• No resistance training for the previous 6 months
• Not currently taking resveratrol supplements
• Stable medication, supplement, dietary, and physical activity regimens for the previous 3 months and no plans to change throughout the study period
• Body mass at least 110 lbs

Exclusion Criteria:

• Medical complications that could increase risk during exercise (e.g., cardiovascular disease, uncontrolled hypertension, type 1 or 2 diabetes, orthopedic contraindication to exercise, kidney disease, etc.)
• Cannabis or nicotine use
• Consume more than 7 alcohol-containing beverages per week

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Resveratrol (RSV) group; 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.	Behavioral: Resistance training; After pre-testing, participants will perform full-body strength training three times per week for two 6-week blocks. The acute program variables (sets, repetitions, training frequency) will follow a non-linear periodized, progressive design consisting of muti-joint and single-joint exercises. Exercise stress will be varied by using different exercises and loads. The two training blocks will be separated by a mid-intervention testing week, allowing for the study team to monitor participants' progress, communicate progress to participants to promote adherence, and adjust target loads as appropriate for the second half of the intervention. An additional testing week will follow the second 6-week block.; Other Names: Strength training; Dietary supplement: Resveratrol 500 mg oral once daily.; 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.
Placebo Comparator: Placebo; 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.	Behavioral: Resistance training; After pre-testing, participants will perform full-body strength training three times per week for two 6-week blocks. The acute program variables (sets, repetitions, training frequency) will follow a non-linear periodized, progressive design consisting of muti-joint and single-joint exercises. Exercise stress will be varied by using different exercises and loads. The two training blocks will be separated by a mid-intervention testing week, allowing for the study team to monitor participants' progress, communicate progress to participants to promote adherence, and adjust target loads as appropriate for the second half of the intervention. An additional testing week will follow the second 6-week block.; Other Names: Strength training; Dietary supplement: Placebo; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Circulating extracellular vesicle microRNA profile	Circulating extracellular vesicles will be isolated from plasma and their microRNA cargo will be sequenced.	During pre-, mid-, and post-testing (each separated by about 6 weeks)
Muscle torque	Participants will be instructed to try and straighten their leg, against resistance, as forcefully as possible and maximal torque of the quadriceps assessed using a dynamometer.	During pre-, mid-, and post-testing (each separated by about 6 weeks)
Muscle fatigability	Participants will perform 32 repetitions of knee extensions on a dynamometer and the change in torque from the beginning to the end will be used to indicate fatigability.	During pre-, mid-, and post-testing (each separated by about 6 weeks)
Muscle strength	Participants will perform submaximal testing to assess strength on key exercises included in the strength training protocol.	During pre-, mid-, and post-testing (each separated by about 6 weeks)
Appendicular skeletal muscle mass index	Assessed using dual-energy x-ray absorptiometry (DEXA)	During pre-, mid-, and post-testing (each separated by about 6 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Waist-to-hip ratio	Waist and hip circumferences measured using measuring tape	During pre-, mid-, and post-testing (each separated by about 6 weeks)
Vascular function	Flow-mediated dilation	During pre-, mid-, and post-testing (each separated by about 6 weeks)
Cognitive function	Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)	During pre-, mid-, and post-testing (each separated by about 6 weeks)
Grip strength	Handgrip dynamometry	During pre-, mid-, and post-testing (each separated by about 6 weeks)
Lower body strength/endurance	Chair stand test (30 seconds)	During pre-, mid-, and post-testing (each separated by about 6 weeks)
Gait speed	4-m walk test	During pre-, mid-, and post-testing (each separated by about 6 weeks)

Collaborators and Investigators

• Sponsor: Texas Tech University
• Collaborators: National Strength and Conditioning Association
• Investigators: Principal Investigator: Danielle E Levitt, PhD, Texas Tech University

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: September 3, 2024
• First Submitted That Met QC Criteria: September 3, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): June 29, 2025
• Last Update Submitted That Met QC Criteria: June 27, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Aging; Sarcopenia; Resveratrol; Resistance training; Extracellular Vesicles; MicroRNAs
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Platelet Aggregation Inhibitors; Antioxidants; Protective Agents; Resveratrol
• Other Study ID Numbers: YI-2024-02; IRB 2024-587 (Other Identifier: Texas Tech University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

De-identified data from human participants (other than large-scale data) will be deposited into the TTU Dataverse with restricted access - by request only. Data will be linked only with a unique code.

MicroRNA sequencing data will be deposited to the Gene Expression Omnibus (GEO).

The following will be submitted to accompany data:

• Full study protocol
• Names and descriptions of data sets
• Annotated data collection forms
• Data dictionary
• Documentation of calculated variables
• Any changes made to the protocol over time
• Frozen datasets used for the primary publication, when applicable

• IPD Sharing Time Frame: Dr. Danielle Levitt (PI) will deposit data into the appropriate repositories. Data upload will occur when publications associated with each data set are submitted and made public (where applicable) upon acceptance.

IPD Sharing Access Criteria

Human participants data (except large-scale data sets)- reasonable requests must be submitted to the TTU Dataverse.

MicroRNA sequencing data will be available in large-scale output format with no identifiable information (unique code).

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No