NCT05392582

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
20mo left

Started Nov 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress47%
Nov 2024Jan 2028

First Submitted

Initial submission to the registry

May 20, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 26, 2022

Completed
2.5 years until next milestone

Study Start

First participant enrolled

November 12, 2024

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

December 5, 2025

Status Verified

December 1, 2025

Enrollment Period

2.1 years

First QC Date

May 20, 2022

Last Update Submit

December 1, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Inflammation

    IL-6 levels

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

Study Arms (2)

Young

Young healthy adult participants

Older

Older healthy adult participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy young and older adults

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

Study Officials

  • Micah Drummond

    The University of Utah

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Micah Drummond, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 20, 2022

First Posted

May 26, 2022

Study Start

November 12, 2024

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2028

Last Updated

December 5, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

No plan has been put into place

Locations