NCT06585865

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress79%
Jun 2025Aug 2026

First Submitted

Initial submission to the registry

September 3, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
9 months until next milestone

Study Start

First participant enrolled

June 13, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

June 29, 2025

Status Verified

June 1, 2025

Enrollment Period

1 year

First QC Date

September 3, 2024

Last Update Submit

June 27, 2025

Conditions

Keywords

Resistance trainingAgingResveratrolSarcopeniaExtracellular VesiclesMicroRNAs

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (6)

  • Waist-to-hip ratio

    During pre-, mid-, and post-testing (each separated by about 6 weeks)

  • Vascular function

    During pre-, mid-, and post-testing (each separated by about 6 weeks)

  • Cognitive function

    During pre-, mid-, and post-testing (each separated by about 6 weeks)

  • Grip strength

    During pre-, mid-, and post-testing (each separated by about 6 weeks)

  • Lower body strength/endurance

    During pre-, mid-, and post-testing (each separated by about 6 weeks)

  • +1 more secondary outcomes

Study Arms (2)

Resveratrol (RSV) group

EXPERIMENTAL

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 trainingDietary Supplement: Resveratrol 500 mg oral once daily.

Placebo

PLACEBO COMPARATOR

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 trainingDietary Supplement: Placebo

Interventions

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.

Also known as: Strength training
PlaceboResveratrol (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.

Resveratrol (RSV) group
PlaceboDIETARY_SUPPLEMENT

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.

Placebo

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Kinesiology & Sport Management, Texas Tech University

Lubbock, Texas, 79409, United States

RECRUITING

MeSH Terms

Conditions

Sarcopenia

Interventions

Resistance TrainingResveratrol

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaStilbestrolsStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolyphenolsPhenols

Study Officials

  • Danielle E Levitt, PhD

    Texas Tech University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Danielle E Levitt, PhD

CONTACT

Jacob A Mota, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: After pre-testing, participants will be randomized to supplement with resveratrol (500 mg) or placebo for 14 weeks. All participants will complete two 6-week blocks of supervised strength training (full body, 3 days/week); each block will be followed by one week of testing.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2024

First Posted

September 19, 2024

Study Start

June 13, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

June 29, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL
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.
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).

Locations