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Recruiting

NCT Number: NCT05392582

MicroRNA Regulation of Chronic Inflammation During Aging

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The University of Utah

Salt Lake City, Utah, 84112, United States

Location status: Recruiting

Location contact

Micah Drummond

PRINCIPAL_INVESTIGATOR

Micah Drummond, PhD

CONTACT

801-213-2737

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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.

Treatment and study plan

Primary outcomes

  1. Inflammation

    Time frame: Determined in older adults and in younger adults at a single visit (baseline).

    IL-6 levels

Study contacts

Contact information is provided by the study sponsor or research team.

Micah Drummond, PhD

CONTACT

[email protected]

801-213-2737

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
May 26, 2022
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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