NCT06617195

Brief Summary

The purpose of this research is to understand how chronic inflammation affects muscle function and responses to exercise in older adults.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
53mo left

Started Jan 2025

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress24%
Jan 2025Sep 2030

First Submitted

Initial submission to the registry

September 13, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 27, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

January 14, 2025

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2028

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2030

Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

3.7 years

First QC Date

September 13, 2024

Last Update Submit

January 19, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Anabolic response

    Skeletal muscle protein synthesis rates will be measured from isotopic enrichment of muscle proteins

    2 months

Study Arms (2)

Young

Men and women between the ages of 21-35 years will be recruited for this study. All participants will complete an outpatient study day (body composition, blood draw, treadmill test, strength test) and an inpatient study day (muscle biopsies, fat biopsies, indirect calorimetry, exercise test).

Other: Exercise

Older

Men and women between the ages of 70-85 years will be recruited for this study. All participants will complete an outpatient study day (body composition, blood draw, treadmill test, strength test) and an inpatient study day (muscle biopsies, fat biopsies, indirect calorimetry, exercise test).

Other: Exercise

Interventions

Young and older adults will perform a single bout of unaccustomed resistance exercise to evaluate molecular and cellular response in skeletal muscle

OlderYoung

Eligibility Criteria

Age21 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Men and women age 21-35 years or 70-85 years of age

You may not qualify if:

  • Diabetes or fasting plasma glucose 126 mg/dL
  • Body mass index (BMI) 30 kg/m2
  • Anemia (female subjects hemoglobin of \<11 g/dl and male subjects hemoglobin \<12 g/dl)
  • Active coronary artery disease or history of unstable macrovascular disease (unstable angina, myocardial infarction, stroke, and revascularization of coronary, peripheral or carotid artery within 3 months of recruitment)
  • Renal failure (serum creatinine \> 1.5mg/dl)
  • Chronic active liver disease (AST\>144IU/L or ALT\>165IU/L)
  • Oral warfarin group medications or history of blood clotting disorders.
  • Smoking
  • Pregnancy or breastfeeding
  • Alcohol consumption greater than 2 glasses/day or other substance abuse
  • Untreated or uncontrolled hypothyroidism
  • Debilitating chronic disease (at the discretion of the investigators)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Plasma Serum Adipose tissue Skeletal muscle tissue

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ian Lanza

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ian Lanza

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 13, 2024

First Posted

September 27, 2024

Study Start

January 14, 2025

Primary Completion (Estimated)

September 16, 2028

Study Completion (Estimated)

September 16, 2030

Last Updated

January 21, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

Anthropometric data Primary and secondary outcomes

Locations