NCT06053125

Brief Summary

The purpose of this research is to determine how exercise affects fat (adipose) tissue and how changes to adipose tissue that occur during and after exercise might improve health in aging and obesity.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
5mo left

Started Nov 2023

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
active not 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 Progress86%
Nov 2023Oct 2026

First Submitted

Initial submission to the registry

September 7, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 25, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

November 9, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

May 6, 2026

Status Verified

May 1, 2026

Enrollment Period

2.9 years

First QC Date

September 7, 2023

Last Update Submit

May 1, 2026

Conditions

Keywords

exerciseadiposecytokines

Outcome Measures

Primary Outcomes (16)

  • Adipose lymphocyte populations

    The numbers of lymphocytes in the adipose tissue will be assessed by flow cytometry.

    Pre-exercise, immediately post-exercise, and 3 hours after exercise

  • IL6 secreted from adipose tissue measured using the Olink Target Inflammation Panel (includes 96 inflammation-associated proteins)

    The concentration of 96 IL6 will be measured using the targeted inflammation Olink proximity extension assay panel in media obtained from cultured adipose tissue explants. Adipose tissue samples will be cultured for 3 hours, and the culture media will be removed for the assessment of secreted inflammatory proteins. T

    Pre-exercise, immediately post-exercise, and 3 hours after exercise

  • Adipose tissue macrophage populations

    Numbers of macrophages in the adipose tissue will be assessed by immunohistochemistry.

    Pre-exercise, immediately post-exercise, and 3 hours after exercise

  • Adipose tissue gene expression of interleukin (IL)-6 measured by polymerase chain reaction (PCR).

    Gene expression of the inflammatory cytokine IL-6 will be measured in adipose tissue samples using real time (RT)-PCR.

    Pre-exercise, immediately post-exercise, and 3 hours after exercise

  • Adipose tissue gene expression of interleukin (IL)-8 measured by PCR.

    Gene expression of the inflammatory cytokine IL-8 will be assessed in adipose tissue samples using real-time (RT)-PCR.

    Pre-exercise, immediately post-exercise, and 3 hours after exercise

  • Adipose tissue gene expression of cluster of differentiation 68 (CD68) measured by PCR.

    Gene expression of the macrophage marker CD68 be assessed in adipose tissue samples using real time (RT)-PCR.

    Pre-exercise, immediately post-exercise, and 3 hours after exercise

  • Adipose tissue gene expression of cluster of differentiation 163 (CD163) measured by PCR.

    Gene expression of the anti-inflammatory macrophage marker CD163 will be assessed in adipose tissue samples using RT-PCR.

    Pre-exercise, immediately post-exercise, and 3 hours after exercise

  • Adipose tissue gene expression of cluster of differentiation 206 (CD206) measured by PCR.

    Gene expression of the anti-inflammatory macrophage marker CD206 will be assessed in adipose tissue samples using RT-PCR.

    Pre-exercise, immediately post-exercise, and 3 hours after exercise

  • Adipose tissue gene expression of adhesion G-protein coupled receptor E (ADGRE) measured by PCR.

    Gene expression of the macrophage marker ADGRE will be assessed in adipose tissue samples using RT-PCR.

    Pre-exercise, immediately post-exercise, and 3 hours after exercise

  • Adipose tissue gene expression of inducible nitric oxide synthase (INOS) measured by PCR.

    Gene expression of the pro-inflammatory macrophage marker INOS will be assessed in adipose tissue samples using RT-PCR.

    Pre-exercise, immediately post-exercise, and 3 hours after exercise

  • Adipose tissue gene expression of monocyte chemoattractant protein-1 (MCP1) measured by PCR.

    Gene expression of the inflammatory cytokine MCP1 will be assessed in adipose tissue samples using RT-PCR.

    Pre-exercise, immediately post-exercise, and 3 hours after exercise

  • Adipose tissue gene expression of tumor necrosis factor alpha (TNFa) measured by PCR.

    Gene expression of the inflammatory cytokine TNFa will be assessed in adipose tissue samples using RT-PCR.

    Pre-exercise, immediately post-exercise, and 3 hours after exercise

  • Adipose tissue gene expression of leptin (LEPD) measured by PCR.

    Gene expression of the pro-inflammatory adipokine LEPD will be assessed in adipose tissue samples using RT-PCR.

    Pre-exercise, immediately post-exercise, and 3 hours after exercise

  • Adipose tissue gene expression of adiponectin (ADIPOQ) measured by PCR.

    Gene expression of the anti-inflammatory adipokine ADIPOQ will be assessed in adipose tissue samples using RT-PCR.

    Pre-exercise, immediately post-exercise, and 3 hours after exercise

  • Inflammatory proteins found in adipose tissue measured using the Olink Target Inflammation Panel (includes 96 inflammation-associated proteins)

    The concentrations of 96 different inflammatory proteins (including various cytokines and adipokines) will be measured in adipose tissue lysates using the targeted inflammation Olink proximity extension assay panel. This assay measures all 96 proteins in a single assay and all are reported as normalized protein expression values.

    Pre-exercise, immediately post-exercise, and 3 hours after exercise

  • Protein cargo of adipose extracellular vesicles measured using mass spectrometry

    Adipose tissue samples will be cultured for 3 hours, and the culture media will be removed. From this media, extracellular vesicles will be isolated. In these extracellular vesicles, mass spectrometry will be performed to examine the entire proteome (all proteins) contained within these extracellular vesicles. Using the large number of proteins identified, the investigators will examine changes in categories of protein types (e.g., inflammatory proteins, metabolic proteins, transcriptional proteins).

    Pre-exercise, immediately post-exercise, and 3 hours after exercise

Secondary Outcomes (3)

  • Adipocyte cell size

    Pre-exercise, immediately post-exercise, and 3 hours after exercise

  • Plasma IL6 concentrations measured using the Olink Target Inflammation Panel

    Pre-exercise, immediately post-exercise, and 3 hours after exercise

  • Protein cargo of plasma extracellular vesicles measured using mass spectrometry extracellular vesicles

    Pre-exercise, immediately post-exercise, and 3 hours after exercise

Other Outcomes (6)

  • Body fat percentage

    Baseline

  • Cardiorespiratory Fitness

    Baseline

  • White blood count

    Baseline

  • +3 more other outcomes

Study Arms (4)

Older adults with obesity

EXPERIMENTAL

Participants with obesity as determined by the principal investigator and aged 65-85 years will have an adipose tissue biopsy taken from the abdomen before and after exercise.

Procedure: Adipose Tissue BiopsyBehavioral: Exercise

Older adults without obesity

EXPERIMENTAL

Participants with obesity as determined by the principal investigator and aged 65-85 years will have an adipose tissue biopsy taken from the abdomen before and after exercise.

Procedure: Adipose Tissue BiopsyBehavioral: Exercise

Young adults with obesity

EXPERIMENTAL

Participants with obesity as determined by the principal investigator and aged 18-35 years will have an adipose tissue biopsy taken from the abdomen before and after exercise.

Procedure: Adipose Tissue BiopsyBehavioral: Exercise

Young adults without obesity

EXPERIMENTAL

Participants with obesity as determined by the principal investigator and aged 18-35 years will have an adipose tissue biopsy taken from the abdomen before and after exercise.

Procedure: Adipose Tissue BiopsyBehavioral: Exercise

Interventions

Fat sample collected from abdomen before exercise, immediately after exercise, and 3 hours after exercise

Older adults with obesityOlder adults without obesityYoung adults with obesityYoung adults without obesity
ExerciseBEHAVIORAL

30 minutes of exercise on a cycle ergometer exercise machine

Older adults with obesityOlder adults without obesityYoung adults with obesityYoung adults without obesity

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults between the ages of 18-35 OR 65-85.
  • BMI 18.5 kg/m2 - 40 kg/m2
  • Weight stable (≥ 3 months)
  • Generally healthy

You may not qualify if:

  • Participation in ≥ 30 minutes of structured physical activity ≥ 2 days per week.
  • Smoking/tobacco use.
  • Alcohol/substance abuse.
  • Pregnancy and breastfeeding.
  • Anemia.
  • Abnormal renal function.
  • Blood clotting disorders.
  • Coronary artery disease.
  • Uncontrolled thyroid disease.
  • Liver disease.
  • Use of medications known to influence the main outcomes of the study.
  • Orthopedic problems that may be aggravated by exercise.
  • 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

Location

Related Links

MeSH Terms

Conditions

ObesityMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Hawley Kunz, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 7, 2023

First Posted

September 25, 2023

Study Start

November 9, 2023

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

May 6, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations