NCT04103424

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2019

Longer than P75 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

August 23, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

August 23, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 25, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2020

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2022

Completed
Last Updated

February 13, 2024

Status Verified

February 1, 2024

Enrollment Period

1.3 years

First QC Date

August 23, 2019

Last Update Submit

February 12, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in skeletal muscle mitochondrial protein degradation peptide products

    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.

Study Arms (2)

Pre-training Metabolic Study Visit

NO INTERVENTION

Participants will first complete a pre-training metabolic study visit.

Post-training Metabolic Study Visit

EXPERIMENTAL

Participants will complete a second, identical metabolic study visit following 2-weeks of exercise training.

Behavioral: Short-term Exercise Training

Interventions

Participants will perform 2-weeks of supervised exercise training on a stationary bike.

Post-training Metabolic Study Visit

Eligibility Criteria

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

You may qualify if:

  • Age 18-45 years
  • Body mass index (BMI) 18-45 kg/m2
  • Sedentary (\<1 hour of planned exercise per week)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon State University

Corvallis, Oregon, 97331, United States

Location

MeSH Terms

Conditions

OverweightObesityInsulin ResistanceMetabolic DiseasesSedentary Behavior

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersBehavior

Study Officials

  • Sean Newsom, PhD

    Oregon State University

    PRINCIPAL INVESTIGATOR
  • Matthew Robinson, PhD

    Oregon State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Participants will be asked to complete 2 screening visits to determine eligibility. If participants remain eligible, they will be asked to complete 2 metabolic study visits, 1 before and 1 after 2 weeks of supervised exercise training on a stationary bike.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 23, 2019

First Posted

September 25, 2019

Study Start

August 23, 2019

Primary Completion

November 25, 2020

Study Completion

December 3, 2022

Last Updated

February 13, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations