SarcopeniaNCT02638454
Role of MicroRNAs on Age and Contraction-induced Skeletal Muscle Growth
A study testing Acute Resistance Exercise in people with Sarcopenia, run by Tufts University at 1 site in United States.
Trial summary
Sarcopenia is a predictor of functional-limitation, leading to loss of independence, lowered quality of life, and ultimately death. The impaired ability of aged skeletal muscle to adapt to anabolic stimulation may be a factor that contributes to sarcopenia. Read more about this study
- Who is it for?
- Ages 20 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Acute Resistance Exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and Female
- 20-30 or 70-85 years of age
- Sedentary: Must not participate in any regular exercise sessions (participants who walk regularly or walk for exercise are eligible)
- Individuals must confirm good health
- BMI must be between 19-35 kg/m2
- Individuals must be fluent in English
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- Willing to come to the HNRCA laboratory for study visits
- Short Physical Performance Battery of less than 9 (70-85 years of age cohort)
- 10 subjects with Normal Muscle Mass and 10 subjects with Low Muscle Mass as determined by DXA scan (70-85 years of age cohort) Low Muscle Mass is defined as Class I Sarcopenia, Skeletal Muscle Index within 1 to 2 standard deviations from the sex-specific mean of young adults
Who cannot join
- Lost or gained 7.5% or more of their body weight in the past 6 months
- Acute or terminal disease
- Significant immune disorder
- Types I and II Diabetes mellitus
- Uncontrolled hypertension (>180/100 mmHg)
- Neuromuscular disease
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- Subjects must also not be participating in any regular endurance or resistance training exercise during the previous six months.
- Mini-mental state examination (MMSE) score of <23
- Because of the DXA scan and the unknown risk associated with the muscle biopsy procedure, women who are pregnant, planning to become pregnant, or are breastfeeding will be excluded from the study.
- Subjects with a history of any of the following within the past 6 months will be excluded:
- Myocardial infarction in the past 6 months, or other symptomatic coronary artery disease.
- Surgery in previous 6 months
- Upper or lower extremity fracture in the previous 6 months
- Allergy to lidocaine
- Subjects currently taking any of the following drugs or classes of drugs will be excluded:
- Anticoagulant therapy (Warfarin, Coumadin, or Plavix)
- ACE inhibitors
- Drugs that affects neuromuscular function
- Angiotensin receptor blockers
- Androgen or estrogen therapy or other hormone replacement therapy
- Low dose aspirin with known cardiovascular disease (e.g.: reported coronary artery disease, peripheral vascular disease, or previous stroke, or history of transient ischemic attacks)
- Diabetes medications (ie. metformin, insulin therapy, thiazolidinediones, sulfonylureas etc.)
- Chronic corticosteroid therapy
- Laboratory blood test exclusions:
- Estimated GFR <30 mL/min/1.73m2
- Other abnormal screening lab values will be at the discretion of the study physician
Trial locations and contacts
1 site in 1 country.
United States1 site
Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, 02111
About this study
Sarcopenia is a predictor of functional-limitation, leading to loss of independence, lowered quality of life, and ultimately death. The impaired ability of aged skeletal muscle to adapt to anabolic stimulation may be a factor that contributes to sarcopenia. This project will provide novel insights into the role of microRNA in the attenuation of aging skeletal muscle to changes in gene expression after anabolic stimulation.
Read the detailed description
The age-associated loss of skeletal muscle mass and function (sarcopenia) is associated with substantial social and economic costs. The plasticity and adaptability of skeletal muscle to contraction (ie. resistance-exercise) is a fundamental physiological event leading to larger and more robust skeletal muscle. However, muscle growth in response to resistance exercise (RE), like other anabolic stimuli, is attenuated in older adults. The cause of aberrant muscle adaptation with aging is complex. Recent work has revealed a novel role for small non-coding RNAs, called microRNAs (miRNA) in the regulation of gene expression. Using an integrated bioinformatics analysis of protein-coding gene and miRNA array data from young and older men, I identified ten specific miRNAs as important regulators of muscle plasticity (Plasticity Related miRs [PR-miRs]) leading to the transcriptional response to exercise and lean mass in young and older men. However, the precise mechanisms underlying the expression of PR-miRs on age-related changes in muscle anabolism and sarcopenia are currently unknown.
Thus, the overall objective of this K01 application will be to determine the mechanistic role(s) of these PR-miRs in skeletal muscle adaptation to anabolic stimulation in:
- healthy young,
- sarcopenic older and
- age- and functionally-matched non-sarcopenic older males and females.
This will be accomplished by determine the differences in expression of PR-miRs with aging and sarcopenia in response to anabolic stimulation (AIM 1). Mechanistically determine the extent to which manipulation of PR-miR levels in vitro, in human primary myocytes, can reverse anabolic resistance observed with age and sarcopenia (AIM 2) and the effect of altering PR-miRs levels on skeletal muscle growth and development (AIM 3). This project will improve our understanding of the molecular mechanisms that contribute to the loss of skeletal muscle and eventually leading to the development of drug therapies for the treatment of sarcopenia in the ever growing aging population.
- Conditions
- Sarcopenia
- Being tested
- Acute Resistance Exercise
- Keywords
- Exercise, Anabolic Resistance, Skeletal Muscle, microRNA
- Medical subject headings
- Sarcopenia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute Resistance ExerciseProcedure or surgery
Also called Acute Strength Training
1 bout of high-intensity resistance exercise at 80% of the individuals 1 repetition maximum
| Study group | Role | What they receive |
|---|---|---|
| HL-YNG | Active comparator | Healthy young sedentary males and females 20-30 yrs old
Participants will undergo an acute bout of resistance exercise at 80% of their 1 repetition maximum (1RM, maximum strength) and will undergo muscle biopsies before, immediately after and 4 hours after the exercise. Receives: Procedure: Acute Resistance Exercise |
| FL-OLD | Experimental | Functionally-limited older sedentary males and females without sarcopenia (70-85 yrs old)
Participants will undergo an acute bout of resistance exercise at 80% of their 1 repetition maximum (1RM, maximum strength) and will undergo muscle biopsies before, immediately after and 4 hours after the exercise. Receives: Procedure: Acute Resistance Exercise |
| SR-OLD | Experimental | Functionally-limited older sedentary males and females with clinically defined sarcopenia (70-85 yrs old)
Participants will undergo an acute bout of resistance exercise at 80% of their 1 repetition maximum (1RM, maximum strength) and will undergo muscle biopsies before, immediately after and 4 hours after the exercise. Receives: Procedure: Acute Resistance Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of microRNA expression in humans skeletal muscle after an acute bout of high intensity resistance exercise
Determine if the expression of miRNA in skeletal muscle after an acute bout of high-intensity resistance exercise in young, functionally-limited older adults with and without low muscle mass
Measured: Baseline, immediately (within 15-30 min after acute resistance exercise) and 4 hours after acute resistance exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2015 (estimated)
- Study startAug 2015
- Primary completionJan 2019
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roger A Fielding, Tufts University
- Investigators
- Donato A Rivas, PhD, Principal investigator, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02638454
- Sponsor's protocol ID
- 2860
- Status last verified
- Jul 2025
- First submitted
- 17 Dec 2015
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of MicroRNAs on Age and Contraction-induced Skeletal Muscle Growth
- ClinicalTrials.gov ID
- NCT02638454
- Acronym / sponsor ID
- 2860
- Conditions
- Sarcopenia
- Keywords
- Exercise, Anabolic Resistance, Skeletal Muscle, microRNA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 23 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sarcopenia is a predictor of functional-limitation, leading to loss of independence, lowered quality of life, and ultimately death. The impaired ability of aged skeletal muscle to adapt to anabolic stimulation may be a factor that contributes to sarcopenia. This project will provide novel insights into the role of microRNA in the attenuation of aging skeletal muscle to changes in gene expression after anabolic stimulation.
Detailed description
The age-associated loss of skeletal muscle mass and function (sarcopenia) is associated with substantial social and economic costs. The plasticity and adaptability of skeletal muscle to contraction (ie. resistance-exercise) is a fundamental physiological event leading to larger and more robust skeletal muscle. However, muscle growth in response to resistance exercise (RE), like other anabolic stimuli, is attenuated in older adults. The cause of aberrant muscle adaptation with aging is complex. Recent work has revealed a novel role for small non-coding RNAs, called microRNAs (miRNA) in the regulation of gene expression. Using an integrated bioinformatics analysis of protein-coding gene and miRNA array data from young and older men, I identified ten specific miRNAs as important regulators of muscle plasticity (Plasticity Related miRs [PR-miRs]) leading to the transcriptional response to exercise and lean mass in young and older men. However, the precise mechanisms underlying the expression of PR-miRs on age-related changes in muscle anabolism and sarcopenia are currently unknown.
Thus, the overall objective of this K01 application will be to determine the mechanistic role(s) of these PR-miRs in skeletal muscle adaptation to anabolic stimulation in:
- healthy young,
- sarcopenic older and
- age- and functionally-matched non-sarcopenic older males and females.
This will be accomplished by determine the differences in expression of PR-miRs with aging and sarcopenia in response to anabolic stimulation (AIM 1). Mechanistically determine the extent to which manipulation of PR-miR levels in vitro, in human primary myocytes, can reverse anabolic resistance observed with age and sarcopenia (AIM 2) and the effect of altering PR-miRs levels on skeletal muscle growth and development (AIM 3). This project will improve our understanding of the molecular mechanisms that contribute to the loss of skeletal muscle and eventually leading to the development of drug therapies for the treatment of sarcopenia in the ever growing aging population.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HL-YNG | Active comparator | Procedure: Acute Resistance ExerciseHealthy young sedentary males and females 20-30 yrs old Participants will undergo an acute bout of resistance exercise at 80% of their 1 repetition maximum (1RM, maximum strength) and will undergo muscle biopsies before, immediately after and 4 hours after the exercise. |
| FL-OLD | Experimental | Procedure: Acute Resistance ExerciseFunctionally-limited older sedentary males and females without sarcopenia (70-85 yrs old) Participants will undergo an acute bout of resistance exercise at 80% of their 1 repetition maximum (1RM, maximum strength) and will undergo muscle biopsies before, immediately after and 4 hours after the exercise. |
| SR-OLD | Experimental | Procedure: Acute Resistance ExerciseFunctionally-limited older sedentary males and females with clinically defined sarcopenia (70-85 yrs old) Participants will undergo an acute bout of resistance exercise at 80% of their 1 repetition maximum (1RM, maximum strength) and will undergo muscle biopsies before, immediately after and 4 hours after the exercise. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male and Female
- 20-30 or 70-85 years of age
- Sedentary: Must not participate in any regular exercise sessions (participants who walk regularly or walk for exercise are eligible)
- Individuals must confirm good health
- BMI must be between 19-35 kg/m2
Key exclusion criteria (26 listed)
- Lost or gained 7.5% or more of their body weight in the past 6 months
- Acute or terminal disease
- Significant immune disorder
- Types I and II Diabetes mellitus
- Uncontrolled hypertension (>180/100 mmHg)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acute Resistance ExerciseAlso: Acute Strength Training1 bout of high-intensity resistance exercise at 80% of the individuals 1 repetition maximum | Procedure or surgery | FL-OLD, HL-YNG, SR-OLD |
Primary outcome
Change of microRNA expression in humans skeletal muscle after an acute bout of high intensity resistance exercise
Time frame: Baseline, immediately (within 15-30 min after acute resistance exercise) and 4 hours after acute resistance exercise
Determine if the expression of miRNA in skeletal muscle after an acute bout of high-intensity resistance exercise in young, functionally-limited older adults with and without low muscle mass
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donato A Rivas, PhD principal investigator
Tufts University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acute Resistance Exercise in people with Sarcopenia, run by Tufts University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of microRNA expression in humans skeletal muscle after an acute bout of high intensity resistance exercise (time frame: Baseline, immediately (within 15-30 min after acute resistance exercise) and 4 hours after acute resistance exercise). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2025.