NCT05616234

Brief Summary

The proposed study aims to shed light on the function/importance/relevance of exercise-induced changes in exosomes to connective tissues. Exosomes are known to increase robustly in response to exercise. We have previously shown that serum isolated from subjects after they lift heavy weights increases human engineered ligament collagen content and mechanics more than serum from before they lift weight. Further, we showed that exercise-induced changes in hormones could not explain the change in ligament structure or function. These data indicate that there is a significant gap in our understanding of muscle-connective tissue crosstalk. To address this gap, the current proposal seeks to: i) isolate and sequence exosomal RNA (long non-coding, miR, and mRNA) and ii) determine whether exosomes isolated from serum after exercise increase engineered ligament mechanics and collagen content.

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 Nov 2022

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 7, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

November 7, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 15, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 17, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2023

Completed
Last Updated

June 15, 2023

Status Verified

June 1, 2023

Enrollment Period

3 months

First QC Date

November 7, 2022

Last Update Submit

June 13, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Collagen content of ligament constructs

    Ligament constructs will be treated for 7 days with experimental feed medium containing serum, or exosomes isolated from serum, obtained at baseline or post-exercise for determination of collagen content using a hydroxyproline assay.

    15 min post-exercise

Secondary Outcomes (2)

  • Ultimate tensile stress and modulus of ligament constructs

    15 min post-exercise

  • Exosomal RNA

    15 min post-exercise

Study Arms (1)

Exercise trial

EXPERIMENTAL

Participants will perform a bout of exercise. In addition, a baseline and post-exercise blood sample will be drawn.

Procedure: Resistance Exercise

Interventions

Participants will perform a bout of lower body resistance exercise consisting of leg press, leg extension and leg curls.

Exercise trial

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Young healthy adults (18-35 y)
  • Experience with exercise (\>1y)

You may not qualify if:

  • Pregnancy
  • Smoking
  • Receiving any medication that may interfere with the study outcomes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hickey Laboratory

Davis, California, 95616, United States

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Keith Baar, PhD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 7, 2022

First Posted

November 15, 2022

Study Start

November 7, 2022

Primary Completion

February 17, 2023

Study Completion

February 17, 2023

Last Updated

June 15, 2023

Record last verified: 2023-06

Locations