Healthy VolunteersNCT06269653
Measuring Protein Turnover in Humans Across the Lifespan by Metabolic Labeling With Deuterium Oxide
An observational study of Healthy Volunteers, run by National Institute on Aging (NIA) at 1 site in United States.
Trial summary
Background: Proteins are essential to the health and structure of the cells that make up body tissues. Most proteins become damaged over time and are replaced with new ones. This process is called "protein turnover." Stress, disease, and aging can affect this process. Read more about this study
- Who is it for?
- Ages 20 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2024to 1 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be enrolled into the following age-groups: 20-29; 30-39; 40-49; 50-59; 60-69; 70-plus years with 6 participants (3 men and 3 women) in each age group.
Who may be able to join
- To be eligible to participate in this study, an individual must meet all the following criteria:
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female, age >= 20years.
- BMI >20 and <30.
- In good general health as evidenced by medical history/exam/laboratory.
- IL6< 3.5 pg/mL.
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- Ankle Brachial Index (ABI) > 0.9.
- No history of increased bleeding due to either a known medical condition or an undiagnosed cause.
- Does not currently smoke/tobacco use.
- Eligible for muscle biopsy procedures.
- Is not allergic to lidocaine or other local anesthetics.
- Able to speak and read English.
- Ability of subject to understand and the willingness to sign a written informed consent document.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Routinely taking (more than 2x/week) non-steroidal anti-inflammatory agents (NSAIDs) and unwilling to stop taking them for the duration of the study.
- Taking medications that could increase the chance of bleeding such as anticoagulants/antiplatelet such as Coumadin, Plavix, and Heparin. Low dose (81mg) aspirin use is okay.
- Is unable to reach down to perform wound care of the lower legs.
- Has laboratory evidence of diabetes at screening (fasting glucose >= 126) and/or diabetes requiring treatment, or treatment with any glucose lowering drug(s).
- Has current or history of inflammatory and/or autoimmune diseases.
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- History of keloid formation.
- Researchers are unable to access biopsy sites due to conditions such as wounds, rashes, or large deposits of adipose tissue.
- Is on treatment with an investigational drug or other intervention within 8 weeks of enrollment.
- Has any chronic disease that the study PI considers as a significant comorbidity that affects health and life expectancy.
- Has established genetic diseases such as sickle cell, hemochromatosis (iron overload), cystic fibrosis or Ehlers-Danlos syndrome (connective tissue disorder).
- Has autoimmune diseases such as Hashimoto s thyroiditis, Myasthenia Gravis, or Rheumatoid arthritis.
- Has severe mobility disability as evidenced by inability to walk without aids, perform activities of daily living and to reach down to lower legs to perform wound care.
- Has had active cancer on treatment in the last 10 years.
- Has muscle-skeletal conditions due to diseases or traumas (that cause pathological weakness and/or chronic pain).
- Has any medical condition that requires absolute and continuous need for long term treatment with antibiotics, corticosteroids, immunosuppressors, or pain medications.
- Has important sensory deficits such as legally blind.
- Is currently pregnant or a nursing mother.
- Has history of, or laboratory evidence of HIV, Hepatitis B or C at Screening.
- Has laboratory evidence of Platelets < 100,000 or >600,000 k/microliter.
- Has a positive urine drug screen unless taking prescribed medication and at the discretion of the PI.
- Has a current illness that as judged by the study physician substantially increases the risks associated with performing a biopsy procedure.
- Has a history of an active bleeding disorder such as haemophilia or Von Willebrand disease.
- Is claustrophobic and/or is not eligible to perform MRI as per the MRI eligibility form.
- Has a hip or knee replacement or other medical conditions that prevents MRI research scans from being performed.
- Has a diagnosis of cognitive impairment that clearly prevents the participant from providing informed consent.
- Has a history of, or evidence of heart disease including unstable angina, myocardial infarction, congestive heart failure, cerebrovascular diseases, uncontrolled hypertension, uncontrolled cardiac arrythmias, moderate to severe valvular disease.
- Has a history or has chronic liver disease as evidenced by medical history or ALT, AST, or alkaline phosphatase twice the normal serum concentration.
- Drinks more than three drinks of alcohol per day on average.
- Has a history of, or evidence of chronic kidney disease or serum creatinine >1.1 mg/dL.
- Participants must be able to speak and read English. The reason for this is for safety reasons especially as it relates to the muscle biopsy procedures. Participants will be required to provide medication history and to understand and report any problems post muscle biopsy to the research medical staff. In addition, the medical staff will be contacting the participant after the biopsies to ensure that they are recovering and do not have significant side effects for which the participant must be able to clearly verbalize for the medical staff to determine if additional observation or treatment is indicated.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institute of Aging, Clinical Research Unit
Baltimore, Maryland, 21224
Luigi Ferrucci, M.D., 410-558-8110, ferruccilu@grc.nia.nih.gov
About this study
Background:
Proteins are essential to the health and structure of the cells that make up body tissues. Most proteins become damaged over time and are replaced with new ones. This process is called "protein turnover." Stress, disease, and aging can affect this process. Researchers want to better understand how aging affects protein turnover.
Read more
Objective:
To measure rates of protein turnover in healthy adults.
Eligibility:
Healthy people aged 20 years and older with a body mass index between 20 and 30.
Design:
Participants will have 6 study visits over 4 to 6 weeks. They will fast 12 hours before each visit.
Participants will be screened. They will have a physical exam, with blood and urine tests and tests of their heart function. They will lie down while blood pressure cuffs are used on their arms and legs.
Participants will be given bottles of heavy water to drink at home on a schedule for 21 days. Each bottle holds about 3.5 tablespoons. Heavy water is odorless, colorless, and tasteless, like normal drinking water. It is safe to drink and has been used in research for many years.
Participants will have tests during study visits, including:
Imaging scans of a leg.
Exercise on a treadmill.
Biopsies of muscle, skin, and fat: Small samples of tissue will be cut from the calf and abdomen.
Resting metabolic rate: Participants will lie still and breathe into a mask for 20 minutes.
Knee/grip strength: Participants will do strength tests with their legs. They will squeeze a device with their hands.
D3-Creatine: Participants will take 1 pill of D3-Creatine, which occurs naturally in muscle.
Read the detailed description
Study Description:
A sophisticated biological system of quality control ensures that proteins are maintained in all cells in the right absolute and relative quantities and their architectural characteristics are preserved so that they can perform their biological function. There is evidence from animal models that the half-life of a subset of proteins is longer with aging so that aggregated proteins are retained for longer time than in younger individuals, leading to reduced cellular function. On the other hand, other proteins such as mitochondrial proteins are damaged at a higher rate and are expected to turnover faster to maintain function. This study is aimed at evaluating the half-life of a range of proteins in muscle, peripheral blood mononucleated cells (PBMCs), and skin in participants of different ages and tests the hypothesis that for specific proteins, older persons have different protein turnover than younger persons and that the effect of aging on proteins half-life is also dependent on the specific tissue considered.
Objectives:
Primary Objective: To measure the turnover proteins in humans across tissues, age, and sex.
Secondary Objective: To test the hypothesis that older age is associated with diminished protein turnover.
Endpoints:
Primary Endpoint: The primary endpoint of this study is to characterize the turnover of different proteins in human skeletal muscle.
Secondary Endpoint: The secondary endpoint of this study is to assess whether the turnover of proteins in skeletal muscle is significantly associated with aging.
- Conditions
- Healthy Volunteers
- Keywords
- PROTEIN TURNOVER, Metabolic, Mononucleated Cells, Mitochondrial, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Individuals: 20 - 29 years of age | Age group: 20 -29 (3 men and 3 women) | |
| Healthy Individuals: 30 - 39 year of age | Age group: 30 - 39 (3 men and 3 women) | |
| Healthy Individuals: 40 - 49 years of age | Age group 40 - 49 (3 men and 3 women) | |
| Healthy Individuals: 50 - 59 years of age | Age group: 50 - 59 (3 men and 3 women) | |
| Healthy Individuals: 60 - 69 years of age | Age group: 60 - 69 (3 men and 3 women) | |
| Healthy Individuals: 70 + | Age group: 70+ (3 men and 3 women) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the turnover proteins in humans across tissues, age, and sex.
No data is available on proteins half-life that compare different tissues in humans; and this information would be important to interpret proteomic data. Comprehensively profile the turnover rates and half-lives of different proteins in human skeletal muscle.
Measured: 21 days
Secondary outcomes (1)
Test the hypothesis that older age is associated with diminished protein turnover.
Assess the turnover of proteins in muscle tissue to determine if the turnover of certain proteins and pathways are different with age.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start26 Jun 2024
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Luigi Ferrucci, M.D., Principal investigator, National Institute on Aging (NIA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06269653
- Sponsor's protocol ID
- 10001944
- Other IDs
- 001944-AG
- Status last verified
- 24 Feb 2026
- First submitted
- 16 Feb 2024
- Last updated
- 20 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: There is ongoing discussion within the NIA IRP and a plan has not been finalized yet.
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Protein Turnover in Humans Across the Lifespan by Metabolic Labeling With Deuterium Oxide
- ClinicalTrials.gov ID
- NCT06269653
- Acronym / sponsor ID
- 10001944
- Conditions
- Healthy Volunteers
- Keywords
- PROTEIN TURNOVER, Metabolic, Mononucleated Cells, Mitochondrial, Peripheral
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Study start
- 26 Jun 2024 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 21 Feb 2024 (actual)
- 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.
Background:
Proteins are essential to the health and structure of the cells that make up body tissues. Most proteins become damaged over time and are replaced with new ones. This process is called "protein turnover." Stress, disease, and aging can affect this process. Researchers want to better understand how aging affects protein turnover.
Objective:
To measure rates of protein turnover in healthy adults.
Eligibility:
Healthy people aged 20 years and older with a body mass index between 20 and 30.
Design:
Participants will have 6 study visits over 4 to 6 weeks. They will fast 12 hours before each visit.
Participants will be screened. They will have a physical exam, with blood and urine tests and tests of their heart function. They will lie down while blood pressure cuffs are used on their arms and legs.
Participants will be given bottles of heavy water to drink at home on a schedule for 21 days. Each bottle holds about 3.5 tablespoons. Heavy water is odorless, colorless, and tasteless, like normal drinking water. It is safe to drink and has been used in research for many years.
Participants will have tests during study visits, including:
Imaging scans of a leg.
Exercise on a treadmill.
Biopsies of muscle, skin, and fat: Small samples of tissue will be cut from the calf and abdomen.
Resting metabolic rate: Participants will lie still and breathe into a mask for 20 minutes.
Knee/grip strength: Participants will do strength tests with their legs. They will squeeze a device with their hands.
D3-Creatine: Participants will take 1 pill of D3-Creatine, which occurs naturally in muscle.
Detailed description
Study Description:
A sophisticated biological system of quality control ensures that proteins are maintained in all cells in the right absolute and relative quantities and their architectural characteristics are preserved so that they can perform their biological function. There is evidence from animal models that the half-life of a subset of proteins is longer with aging so that aggregated proteins are retained for longer time than in younger individuals, leading to reduced cellular function. On the other hand, other proteins such as mitochondrial proteins are damaged at a higher rate and are expected to turnover faster to maintain function. This study is aimed at evaluating the half-life of a range of proteins in muscle, peripheral blood mononucleated cells (PBMCs), and skin in participants of different ages and tests the hypothesis that for specific proteins, older persons have different protein turnover than younger persons and that the effect of aging on proteins half-life is also dependent on the specific tissue considered.
Objectives:
Primary Objective: To measure the turnover proteins in humans across tissues, age, and sex.
Secondary Objective: To test the hypothesis that older age is associated with diminished protein turnover.
Endpoints:
Primary Endpoint: The primary endpoint of this study is to characterize the turnover of different proteins in human skeletal muscle.
Secondary Endpoint: The secondary endpoint of this study is to assess whether the turnover of proteins in skeletal muscle is significantly associated with aging.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Healthy Individuals: 20 - 29 years of age | – | –Age group: 20 -29 (3 men and 3 women) |
| Healthy Individuals: 30 - 39 year of age | – | –Age group: 30 - 39 (3 men and 3 women) |
| Healthy Individuals: 40 - 49 years of age | – | –Age group 40 - 49 (3 men and 3 women) |
| Healthy Individuals: 50 - 59 years of age | – | –Age group: 50 - 59 (3 men and 3 women) |
| Healthy Individuals: 60 - 69 years of age | – | –Age group: 60 - 69 (3 men and 3 women) |
| Healthy Individuals: 70 + | – | –Age group: 70+ (3 men and 3 women) |
Who may qualify
- Ages
- 20 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be enrolled into the following age-groups: 20-29; 30-39; 40-49; 50-59; 60-69; 70-plus years with 6 participants (3 men and 3 women) in each age group.
Key inclusion criteria (13 listed)
- To be eligible to participate in this study, an individual must meet all the following criteria:
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female, age >= 20years.
- BMI >20 and <30.
- In good general health as evidenced by medical history/exam/laboratory.
Key exclusion criteria (31 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Routinely taking (more than 2x/week) non-steroidal anti-inflammatory agents (NSAIDs) and unwilling to stop taking them for the duration of the study.
- Taking medications that could increase the chance of bleeding such as anticoagulants/antiplatelet such as Coumadin, Plavix, and Heparin. Low dose (81mg) aspirin use is okay.
- Is unable to reach down to perform wound care of the lower legs.
- Has laboratory evidence of diabetes at screening (fasting glucose >= 126) and/or diabetes requiring treatment, or treatment with any glucose lowering drug(s).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measure the turnover proteins in humans across tissues, age, and sex.
Time frame: 21 days
No data is available on proteins half-life that compare different tissues in humans; and this information would be important to interpret proteomic data. Comprehensively profile the turnover rates and half-lives of different proteins in human skeletal muscle.
1 secondary outcome
Test the hypothesis that older age is associated with diminished protein turnover.
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: Undecided. There is ongoing discussion within the NIA IRP and a plan has not been finalized yet.
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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.
Luigi Ferrucci, M.D. principal investigator
National Institute on Aging (NIA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteers, run by National Institute on Aging (NIA) 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 13 inclusion and 31 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: looking for participants now, as of the sponsor's last update on 20 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Linda M Zukley, Ph.D. ((410) 350-3983, zukleylm@mail.nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the turnover proteins in humans across tissues, age, and sex. (time frame: 21 days). 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 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.