- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04103424
Mitochondrial Remodeling After Exercise
February 12, 2024 updated by: Sean Newsom, Oregon State University
Regulation of mitochondrial health in overweight and obese individuals may be impaired.
The purpose of this study is to identify impairments in regulation of mitochondrial health within skeletal muscle and to determine if short-term exercise training (2-weeks) can reverse such impairments.
The investigator's hypothesis is that pathways that serve to degrade poorly functioning mitochondria in overweight and obese individuals are down-regulated, but that short-term exercise training can restore these pathways to improve skeletal muscle mitochondrial function.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
31
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Oregon
-
Corvallis, Oregon, United States, 97331
- Oregon State University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Age 18-45 years
- Body mass index (BMI) 18-45 kg/m2
- Sedentary (<1 hour of planned exercise per week)
Exclusion Criteria:
- Regular exercise (>1 hour of planned exercise per week)
- Smoking, tobacco or nicotine use within the last 1-year
- Fasting glucose >126mg/dL
- Hypertension (systolic pressure >140 mmHg or diastolic pressure >90 mmHg)
- Chronic metabolic or cardiovascular health conditions
- Pregnant, nursing, irregular menses or post-menopausal
- Lidocaine allergy
- Certain medications
- Physical limitations that prevent safe or successful exercise completion
- Diminished capacity for consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Pre-training Metabolic Study Visit
Participants will first complete a pre-training metabolic study visit.
|
|
|
Experimental: Post-training Metabolic Study Visit
Participants will complete a second, identical metabolic study visit following 2-weeks of exercise training.
|
Participants will perform 2-weeks of supervised exercise training on a stationary bike.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in skeletal muscle mitochondrial protein degradation peptide products
Time Frame: After 2-weeks of exercise training compared with before training.
|
Skeletal muscle mitochondrial protein degradation peptide products after 2-weeks of exercise training compared with before training.
|
After 2-weeks of exercise training compared with before training.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sean Newsom, PhD, Oregon State University
- Principal Investigator: Matthew Robinson, PhD, Oregon State University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 23, 2019
Primary Completion (Actual)
November 25, 2020
Study Completion (Actual)
December 3, 2022
Study Registration Dates
First Submitted
August 23, 2019
First Submitted That Met QC Criteria
September 23, 2019
First Posted (Actual)
September 25, 2019
Study Record Updates
Last Update Posted (Estimated)
February 13, 2024
Last Update Submitted That Met QC Criteria
February 12, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-2019-0124
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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