NCT06223035

Brief Summary

Exercise stimulates a cascade of responses within the human body. For example, exercise results in the release of proteins into the circulation which communicate with cells and organs throughout the body. In fact, recent human research identified more than 600 proteins are released into the blood circulation following short-term exercise, many of which are predicted to come from the skeletal muscle and target the fat tissue. However, identification of these muscle-secreted proteins and their target tissue (i.e. fat tissue) remains extremely challenging. This challenge is because tissue needs to be collected from multiple sites (skeletal muscle and fat) and at multiple timepoints (before and after exercise). This study seeks to address these challenges through the collection of fat and blood both before and after short-term exercise followed by protein detection (of the blood) and gene expression (of the fat tissue).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

November 30, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 25, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

April 18, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 9, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 9, 2024

Completed
Last Updated

March 10, 2025

Status Verified

March 1, 2025

Enrollment Period

4 months

First QC Date

November 30, 2023

Last Update Submit

March 6, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Identification and quantification of exercise-induced proteins released into the blood through the use of proteomic analysis.

    The change in protein abundance within the circulation will be identified by using proteomic-based detection methods. Proteins detected from the control timepoint (before exercise), will be compared to the three timepoints following exercise.

    Before exercise, immediately following exercise, 1-hour following exercise, 3-hours following exercise

Secondary Outcomes (1)

  • Characterize changes in gene expression of the subcutaneous adipose tissue following exercise through the use of bulk RNA-sequencing.

    1 week pre-intervention, 1-hour following, 3-hours following

Study Arms (1)

Secretome characterization and signaling to the adipose tissue

EXPERIMENTAL

To identify possible exercise stimulated secreted proteins which signal to the adipose tissue, subcutaneous adipose and blood will be collected both before and at multiple timepoints following a VO2max test. Adipose will be collected from the abdominal subcutaneous region and blood will be collected from the arm. Blood will be analyzed for change in protein abundance and adipose will be analyzed for change in gene expression.

Other: Exercise

Interventions

Participants will take part in a VO2max test. This will include a graded exercise test (GXT) on a motorized treadmill while wearing a one-way, non-rebreathing valve and nose clip that allows for the evaluation of all expired air. Specifically, we will incorporate the Ellestad Protocol. The Ellestad Protocol is divided into 8 phases which gradually increases in speed and incline throughout the test. The VO2max test will continue until the participant reaches volitional fatigue defined by reaching a rate of perceived exertion (RPE) greater than 19 (using the Borg RPE Scale), OR a respiratory exchange ratio (RER) reaching above 1.1, OR a participant choosing to cease exercise for any reason.

Secretome characterization and signaling to the adipose tissue

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • passing the PARQ questionnaire (i.e. answering "NO" to all questions)
  • being between the ages of 18-45
  • being moderately active (defined as participating in 30 minutes of recreational activity at least once per week for the past 3 months but no more than 3 times per week)
  • non-smoking
  • free of metabolic or cardiovascular diseases

You may not qualify if:

  • unhealed fractures
  • thrombophlebitis (blood clots)
  • recent surgery of the upper or lower extremities (any surgeries in past 6 months at the ankle or foot, or in the past year at the knee, hip, shoulder or elbow)
  • recent uncontrolled bruising
  • recent muscle, bone or joint damage which interferes with regular physical activity
  • taking part in vigorous physical activity more than 3 times per week
  • any prior sensations of chest pain during exercise.
  • individuals who are pregnant as determined by an on-site pregnancy test
  • individuals who are currently taking exogenous hormones
  • individuals who chronically consume NSAIDS or other anti-inflammatory medication (every day for the previous 3 months)
  • failing the PARQ questionnaire as indicated by answering "YES" to any of the questions
  • Having a BMI \>32
  • Any medical condition that in the opinion of the investigator will confound interpretation of data for analysis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rockefeller University

New York, New York, 10065, United States

Location

Related Publications (1)

  • Walker JM, Garcet S, Aleman JO, Mason CE, Danko D, Butler D, Zuffa S, Swann JR, Krueger J, Breslow JL, Holt PR. Obesity and ethnicity alter gene expression in skin. Sci Rep. 2020 Aug 21;10(1):14079. doi: 10.1038/s41598-020-70244-2.

    PMID: 32826922BACKGROUND

MeSH Terms

Conditions

Obesity

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Luke Olsen, PhD

    The Rockefeller University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2023

First Posted

January 25, 2024

Study Start

April 18, 2024

Primary Completion

August 9, 2024

Study Completion

August 9, 2024

Last Updated

March 10, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations