Chronic InflammationNCT05392582
MicroRNA Regulation of Chronic Inflammation During Aging
An observational study of Chronic Inflammation, run by University of Utah at 1 site in United States.
Trial summary
This is an observational study enrolling healthy individuals aged 18-35 and 65y and older to determine the health of immune cells in the blood and how these cells create inflammation and effect health as we age. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Inflammation
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2024to 1 Jan 2028
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy young and older adults
Who may be able to join
- Age between 18 - 35y; 65y and older
- BMI: <30 kg/m2
- Ability to sign informed consent
- For older participant group: Clinical Frailty Scale score < 3 and Mini-Cog score > 3
- Good general medical health, ambulatory and in independent living setting
Who cannot join
- History of cardiovascular disease (e.g., CHF, CAD, MI, CVA)
- History of endocrine or metabolic disease such as hypo/hyperthyroidism and diabetes (Treated hypo/hyperthyroid for at least 6 months will be permitted)
- History of kidney disease or failure (CKD > stage 4)
- History of vascular disease
- Uncontrolled hypertension - Elevated systolic pressure >150 or a diastolic blood pressure > 100
- Cancer or history of successfully treated cancer (less than 1 year) other than basal cell carcinoma
Show all 16Show fewer
- Chronic systemic corticosteroid use (≥ 2 weeks) within 4 weeks of enrollment and for study duration (intra-articular/topical/inhaled therapeutic or physiologic doses of corticosteroids will be permitted)
- Chronic anti-inflammatory medication use (≥ 2 weeks) within 4 weeks of enrollment
- Chronic inflammatory conditions (e.g., Rheumatoid Arthritis, Crohn's, fibromyalgia, lupus, colitis) HIV, Hepatitis B and C
- History of stroke with motor disability
- A recent history (<12 months) of GI bleed
- History of liver disease or AST/ALT 2 times above the normal limit
- History of respiratory disease (acute upper respiratory infection, history of chronic lung disease)
- Current smokers or current tobacco use
- Current pregnancy as determined by positive pregnancy test
- Any staff members who report directly to the principal investigators.
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
The University of Utah
Salt Lake City, Utah, 84112
Micah Drummond, PhD, 801-213-2737
micah.drummond@hsc.utah.edu
About this study
This is an observational study enrolling healthy individuals aged 18-35 and 65y and older to determine the health of immune cells in the blood and how these cells create inflammation and effect health as we age. It is hoped that once the nature of this relationship has been discovered we can more effectively design therapies to reduce this inflammation.
The enrollment goal is 40 participants. The study will occur over the course of 1 month which will include a screening visit and a second visit where the participants will undergo an oral glucose tolerance test, blood draws and leg strength \& exercise tests.
Read the detailed description
We will recruit healthy, non-obese (<30kg/m2 BMI) younger (N=20; 18-35y) and older (N=20; >65y) male and female participants (as determined by sample size calculation) in the Salt Lake City area.
- VISIT 1 (Screening, visit duration: 1 hour): Once the participant is identified, they will be scheduled for a screening visit at the CTSI (421 Wakara Way) to see if they meet incl/excl criteria and to sign an informed consent document. As part of the visit, Upon arrival, we will gather basic health information such as height, weight, blood pressure, and heart rate.
- Participant will undergo the following procedures: a blood screening (30ml of blood collected)
- For older cohort: The clinical frailty scale (CFS) and Mini-Cog© cognitive assessment
- VISIT 2 (visit duration: 3 hours) Following a 10h fast, participants will arrive in the morning. Upon arrival, we may gather basic health information from the participant such as height, weight, blood pressure, and heart rate. The procedures to take place at this visit are as follows:
- 120 mL serum blood sample collection. Samples will be used to identify the immune cell populations in the blood, regulators of these immune cells and how these cells function.
- Oral glucose tolerance test (OGTT)- participants will be asked to complete a test to determine their blood sugar levels. We will ask them to drink a sugary liquid (glucola) and then rest quietly while we measure changes in their blood sugar levels. We will draw 20 ml of blood during this test (~1 tablespoon). OGTT will take approximately 2hours.
- Leg strength tests at the SMERF facility. Isometric strength will be assessed in both legs with a maximal voluntary isometric contraction effort developed by the knee extensors (quadriceps) on a isokinetic dynamometer. For lower extremity extension power testing a Nottingham power rig will be used. Total time for these tests will take 45 minutes.
- Conditions
- Chronic Inflammation
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 |
|---|---|---|
| Young | Young healthy adult participants | |
| Older | Older healthy adult participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammation
IL-6 levels
Measured: Determined in older adults and in younger adults at a single visit (baseline).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start12 Nov 2024
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic InflammationStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Micah Drummond, University of Utah
- Investigators
- Micah Drummond, Principal investigator, The University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05392582
- Sponsor's protocol ID
- 153158
- Status last verified
- Dec 2025
- First submitted
- 20 May 2022
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan has been put into place
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MicroRNA Regulation of Chronic Inflammation During Aging
- ClinicalTrials.gov ID
- NCT05392582
- Acronym / sponsor ID
- 153158
- Conditions
- Chronic Inflammation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 26 May 2022 (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.
This is an observational study enrolling healthy individuals aged 18-35 and 65y and older to determine the health of immune cells in the blood and how these cells create inflammation and effect health as we age. It is hoped that once the nature of this relationship has been discovered we can more effectively design therapies to reduce this inflammation.
The enrollment goal is 40 participants. The study will occur over the course of 1 month which will include a screening visit and a second visit where the participants will undergo an oral glucose tolerance test, blood draws and leg strength \& exercise tests.
Detailed description
We will recruit healthy, non-obese (<30kg/m2 BMI) younger (N=20; 18-35y) and older (N=20; >65y) male and female participants (as determined by sample size calculation) in the Salt Lake City area.
- VISIT 1 (Screening, visit duration: 1 hour): Once the participant is identified, they will be scheduled for a screening visit at the CTSI (421 Wakara Way) to see if they meet incl/excl criteria and to sign an informed consent document. As part of the visit, Upon arrival, we will gather basic health information such as height, weight, blood pressure, and heart rate.
- Participant will undergo the following procedures: a blood screening (30ml of blood collected)
- For older cohort: The clinical frailty scale (CFS) and Mini-Cog© cognitive assessment
- VISIT 2 (visit duration: 3 hours) Following a 10h fast, participants will arrive in the morning. Upon arrival, we may gather basic health information from the participant such as height, weight, blood pressure, and heart rate. The procedures to take place at this visit are as follows:
- 120 mL serum blood sample collection. Samples will be used to identify the immune cell populations in the blood, regulators of these immune cells and how these cells function.
- Oral glucose tolerance test (OGTT)- participants will be asked to complete a test to determine their blood sugar levels. We will ask them to drink a sugary liquid (glucola) and then rest quietly while we measure changes in their blood sugar levels. We will draw 20 ml of blood during this test (~1 tablespoon). OGTT will take approximately 2hours.
- Leg strength tests at the SMERF facility. Isometric strength will be assessed in both legs with a maximal voluntary isometric contraction effort developed by the knee extensors (quadriceps) on a isokinetic dynamometer. For lower extremity extension power testing a Nottingham power rig will be used. Total time for these tests will take 45 minutes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Young | – | –Young healthy adult participants |
| Older | – | –Older healthy adult participants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy young and older adults
Key inclusion criteria (5 listed)
- Age between 18 - 35y; 65y and older
- BMI: <30 kg/m2
- Ability to sign informed consent
- For older participant group: Clinical Frailty Scale score < 3 and Mini-Cog score > 3
- Good general medical health, ambulatory and in independent living setting
Key exclusion criteria (16 listed)
- History of cardiovascular disease (e.g., CHF, CAD, MI, CVA)
- History of endocrine or metabolic disease such as hypo/hyperthyroidism and diabetes (Treated hypo/hyperthyroid for at least 6 months will be permitted)
- History of kidney disease or failure (CKD > stage 4)
- History of vascular disease
- Uncontrolled hypertension - Elevated systolic pressure >150 or a diastolic blood pressure > 100
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
Inflammation
Time frame: Determined in older adults and in younger adults at a single visit (baseline).
IL-6 levels
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 5 Dec 2025.
- Individual participant dataSharing planned: No. No plan has been put into place
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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.
Micah Drummond principal investigator
The University of Utah
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 Chronic Inflammation, run by University of Utah 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 5 inclusion and 16 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 5 Dec 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?
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 Micah Drummond, PhD (801-213-2737, micah.drummond@hsc.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammation (time frame: Determined in older adults and in younger adults at a single visit (baseline).). 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 5 Dec 2025.