Nutrient SensingNCT02999802
Nutrient Sensing & Signaling in Aging Muscle
A study testing Exercise in people with Nutrient Sensing, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
This research seeks to better understand how cellular and molecular bases of changes associated with aging contribute to decreased function and increased incidence of disease. Specific mechanism in muscle responsible for anabolic resistance - a key component of sarcopenia and frailty - will be identified. Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrient Sensing
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to 21 Dec 2016
- 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 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 65-80 yrs
- Stable body weight for at least 1 year
- Ability to sign consent form:
Who cannot join
- Exercise training (>2 weekly sessions of moderate to high intensity aerobic or resistance exercise)
- Physical dependence or frailty (impairment in the Activities of Daily Living (ADL), history of falls (>2/year), or >5% weight loss in the past year)
- Significant heart, liver, kidney, blood, or respiratory disease
- Peripheral vascular disease
- Diabetes mellitus or other untreated endocrine disease
- Active cancer
Show all 12Show fewer
- Acute infectious disease or history of chronic infections
- Recent (within 3 months) treatment with anabolic steroids, or prolonged systemic corticosteroids.
- Alcohol or drug abuse
- Tobacco use (smoking or chewing)
- Malnutrition (BMI < 18.5 kg/sq meter)
- Obesity (BMI > 30 kg/sq meter)
Trial locations and contacts
1 site in 1 country.
About this study
This research seeks to better understand how cellular and molecular bases of changes associated with aging contribute to decreased function and increased incidence of disease. Specific mechanism in muscle responsible for anabolic resistance - a key component of sarcopenia and frailty - will be identified. The proposed research is relevant to public health because the discovery of new targets for interventions and novel therapeutics to improve muscle strength and function, prevent falls, and reduce physical dependency will improve the healthspan and quality of life in older adults by improving their physical function and ability to remain independent and healthy for a longer period of time.
Read the detailed description
Anabolic resistance to nutrition is the reduced ability of skeletal muscle to increase protein synthesis in response to feeding. It is a major contributor to muscle atrophy in aging, inactivity, burns, trauma, and cancer cachexia. The effects of anabolic resistance on health and physical function are important. For example, the loss of muscle mass and strength with aging (sarcopenia) increases the risk for falls, physical dependency and morbidity in older adults. A major determinant of muscle size is muscle protein content, which is controlled by the fine balance between protein synthesis and breakdown. Recently, investigators have found that amino acids and exercise independently increase muscle protein synthesis and overall anabolism by activating the mammalian/mechanistic target of rapamycin complex 1 (mTORC1) signaling pathway in humans. Aging and inactivity reduce these anabolic effects, but the underlying mechanisms of anabolic resistance are not known. The purpose of this application is to better understand how anabolic resistance develops in skeletal muscle. The long-term goal is to identify specific molecular targets for the development of evidence-based clinical interventions to counteract anabolic resistance and muscle wasting in clinical populations. Here, investigators will focus on one potential mechanisms underlying anabolic resistance to amino acids: activation of mTORC1 in human muscle cells. The central hypothesis is that the physical activity restores mTORC1 signaling which is the primary contributor to anabolic resistance in human skeletal muscle. Investigators will test this hypothesis in healthy subjects with the following specific aim: Determine the effect of increasing habitual physical activity on anabolic resistance. Investigators will study human subjects utilizing stable isotopes model to measure amino acid kinetics and muscle protein metabolism in combination with molecular analysis of muscle to determine the regulatory role of amino acids, physical inactivity, and amino acid transporter functional activity on mTORC1. The proposed approach is innovative because it represents a new and substantial departure from the status quo as investigators will examine the underlying mechanisms of anabolic resistance to nutrition using novel methodological approaches. The proposed research is significant because it will lead to the development of evidence-based interventions to treat sarcopenia and muscle wasting.
- Conditions
- Nutrient Sensing
- Being tested
- Exercise
- Keywords
- Nutrient Sensing, Exercise, Elderly
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Progressive resistance exercise training
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Determining the effect of 12 weeks of resistance training exercise on the response of muscle amino acid sensing Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in muscle protein synthesis in response to amino acids
Measurement of the change in muscle protein synthesis in response to amino acids by standard stable isotope method
Measured: Change from baseline to 3 months
Secondary outcomes (2)
Muscle mass
Measurement in the change in muscle mass by DEXA scan
Measured: Change from baseline to 3 months
Muscle function
Measurement of the change in muscle function by standard methods
Measured: Change from baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2016 (estimated)
- Study startOct 2015
- Primary completion21 Dec 2016
- Study completion21 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nutrient SensingStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Medical Branch, Galveston
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Blake B Rasmussen, PhD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02999802
- Sponsor's protocol ID
- 15-0226
- Other IDs
- R56AG051267
- Status last verified
- Aug 2017
- First submitted
- 9 Dec 2016
- Last updated
- 13 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Von Ruff ZD, Miller MJ, Moro T, Reidy PT, Ebert SM, Volpi E, Adams CM, Rasmussen BB. Resistance exercise training in older men reduces ATF4-activated and senescence-associated mRNAs in skeletal muscle. Geroscience. 2025 Jun;47(3):4601-4622. doi: 10.1007/s11357-025-01564-2. Epub 2025 Feb 27.
PubMed 40011348Moro T, Brightwell CR, Deer RR, Graber TG, Galvan E, Fry CS, Volpi E, Rasmussen BB. Muscle Protein Anabolic Resistance to Essential Amino Acids Does Not Occur in Healthy Older Adults Before or After Resistance Exercise Training. J Nutr. 2018 Jun 1;148(6):900-909. doi: 10.1093/jn/nxy064.
PubMed 29796648
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrient Sensing & Signaling in Aging Muscle
- ClinicalTrials.gov ID
- NCT02999802
- Acronym / sponsor ID
- 15-0226
- Conditions
- Nutrient Sensing
- Keywords
- Nutrient Sensing, Exercise, Elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Oct 2015
- Primary completion
- 21 Dec 2016 (actual)
- Study completion
- 21 Dec 2016 (actual)
- First posted
- 21 Dec 2016 (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.
This research seeks to better understand how cellular and molecular bases of changes associated with aging contribute to decreased function and increased incidence of disease. Specific mechanism in muscle responsible for anabolic resistance - a key component of sarcopenia and frailty - will be identified. The proposed research is relevant to public health because the discovery of new targets for interventions and novel therapeutics to improve muscle strength and function, prevent falls, and reduce physical dependency will improve the healthspan and quality of life in older adults by improving their physical function and ability to remain independent and healthy for a longer period of time.
Detailed description
Anabolic resistance to nutrition is the reduced ability of skeletal muscle to increase protein synthesis in response to feeding. It is a major contributor to muscle atrophy in aging, inactivity, burns, trauma, and cancer cachexia. The effects of anabolic resistance on health and physical function are important. For example, the loss of muscle mass and strength with aging (sarcopenia) increases the risk for falls, physical dependency and morbidity in older adults. A major determinant of muscle size is muscle protein content, which is controlled by the fine balance between protein synthesis and breakdown. Recently, investigators have found that amino acids and exercise independently increase muscle protein synthesis and overall anabolism by activating the mammalian/mechanistic target of rapamycin complex 1 (mTORC1) signaling pathway in humans. Aging and inactivity reduce these anabolic effects, but the underlying mechanisms of anabolic resistance are not known. The purpose of this application is to better understand how anabolic resistance develops in skeletal muscle. The long-term goal is to identify specific molecular targets for the development of evidence-based clinical interventions to counteract anabolic resistance and muscle wasting in clinical populations. Here, investigators will focus on one potential mechanisms underlying anabolic resistance to amino acids: activation of mTORC1 in human muscle cells. The central hypothesis is that the physical activity restores mTORC1 signaling which is the primary contributor to anabolic resistance in human skeletal muscle. Investigators will test this hypothesis in healthy subjects with the following specific aim: Determine the effect of increasing habitual physical activity on anabolic resistance. Investigators will study human subjects utilizing stable isotopes model to measure amino acid kinetics and muscle protein metabolism in combination with molecular analysis of muscle to determine the regulatory role of amino acids, physical inactivity, and amino acid transporter functional activity on mTORC1. The proposed approach is innovative because it represents a new and substantial departure from the status quo as investigators will examine the underlying mechanisms of anabolic resistance to nutrition using novel methodological approaches. The proposed research is significant because it will lead to the development of evidence-based interventions to treat sarcopenia and muscle wasting.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: ExerciseDetermining the effect of 12 weeks of resistance training exercise on the response of muscle amino acid sensing |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 65-80 yrs
- Stable body weight for at least 1 year
- Ability to sign consent form:
Key exclusion criteria (12 listed)
- Exercise training (>2 weekly sessions of moderate to high intensity aerobic or resistance exercise)
- Physical dependence or frailty (impairment in the Activities of Daily Living (ADL), history of falls (>2/year), or >5% weight loss in the past year)
- Significant heart, liver, kidney, blood, or respiratory disease
- Peripheral vascular disease
- Diabetes mellitus or other untreated endocrine disease
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 |
|---|---|---|
| ExerciseProgressive resistance exercise training | Behavioural | Exercise |
Primary outcome
Change in muscle protein synthesis in response to amino acids
Time frame: Change from baseline to 3 months
Measurement of the change in muscle protein synthesis in response to amino acids by standard stable isotope method
2 secondary outcomes
Muscle mass
Time frame: Change from baseline to 3 months
Muscle function
Time frame: Change from baseline to 3 months
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 13 Jun 2018.
- Derived from this study: PubMed 40011348Von Ruff ZD, Miller MJ, Moro T, Reidy PT, Ebert SM, Volpi E, Adams CM, Rasmussen BB. Resistance exercise training in older men reduces ATF4-activated and senescence-associated mRNAs in skeletal muscle. Geroscience. 2025 Jun;47(3):4601-4622. doi: 10.1007/s11357-025-01564-2. Epub 2025 Feb 27.
- Derived from this study: PubMed 29796648Moro T, Brightwell CR, Deer RR, Graber TG, Galvan E, Fry CS, Volpi E, Rasmussen BB. Muscle Protein Anabolic Resistance to Essential Amino Acids Does Not Occur in Healthy Older Adults Before or After Resistance Exercise Training. J Nutr. 2018 Jun 1;148(6):900-909. doi: 10.1093/jn/nxy064.
- Individual participant dataSharing planned: No
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.
Blake B Rasmussen, PhD principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Nutrient Sensing, run by The University of Texas Medical Branch, Galveston 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 3 inclusion and 12 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 13 Jun 2018. 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 in muscle protein synthesis in response to amino acids (time frame: Change from baseline to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02999802, which also lists 2 linked publications.
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 13 Jun 2018.