Identification of Novel Skeletal Muscle-derived Factors That Promote Lipid Oxidation (Columbus) (Columbus)

February 5, 2024 updated by: AdventHealth Translational Research Institute

Identification of Novel Skeletal Muscle-derived Factors That Promote Lipid Oxidation in Both Skeletal Muscle and Adipose Tissue

The purpose of this study is to collect data to help researchers identify factors, such as certain proteins or genetic codes, that are secreted from muscle that are associated with the beneficial effects of exercise.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Study Objectives:

  1. To identify specific changes in messenger ribonucleic acid (mRNA)/micro ribonucleic acid (miRNA) expression in muscle associated with higher or lower relative measures of mitochondrial capacity and fat oxidation.
  2. To identify secreted factors/miRNAs that specifically relate to the metabolic response of muscle and that are present after a single initial bout of exercise.
  3. To collect the appropriate clinical samples (muscle and adipose tissue, plasma/serum) to enable validation of myokines associated with changes in oxygen consumption/mitochondrial content via in vivo and in vitro discovery efforts.

Study Type

Interventional

Enrollment (Estimated)

56

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

  • United States
    • Florida
      • Orlando, Florida, United States, 32804
        • Translational Research Institute for Metabolism and Diabetes

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 40 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Applicable to all Groups

  • Healthy men and women, aged 18 - 40, inclusive.
  • Willing to stop alcohol and caffeine consumption for 48 hours preceding each blood draw

Applicable to Group 1

  • BMI between 22 and 29.9 kg/m2
  • Not involved in regular exercise program
  • Willing to exercise every day for the study period

Applicable to Group 2

  • BMI between 22 and 29.9 kg/m2

  • Maximal oxygen uptake (VO2max) ≥ 45 ml/kg fat-free mass

    /min

  • Engaged in a minimum of 1.5 h of moderate to vigorous intensity aerobic exercise 3 times/ week

Applicable to Group 3

  • BMI ≥ 30 kg/m2 and weight ≤ 350 lbs
  • Not involved in a regular exercise program

Exclusion Criteria:

Applicable to All Groups

  • History of Type 2 Diabetes
  • "Unfavorable anatomy" for continuous venous blood sample collection
  • Abnormal resting ECG
  • Significant renal, cardiac, liver, lung, or neurological disease (controlled hypertension is acceptable if baseline bp < 140/90 on medications)
  • Use of drugs known to affect energy metabolism or body weight: including, but not limited to: orlistat, sibutramine, ephedrine, phenylpropanolamine, corticosterone, etc
  • Current treatment with blood thinners or anti-platelet medications that cannot be safely stopped for testing procedures
  • New onset (<3 months on a stable regime) use of oral contraceptives or hormone replacement therapy
  • Alcohol or other drug abuse
  • Smoking within the past 3 months
  • Females that are currently or have been pregnant or are currently or have nursed a child within the last 12 months (minimum).
  • Parental enrollment into the study that compromises the well being of the child [no partner or connected caregiver]
  • Unwilling or unable to abstain from caffeine or alcohol 48 hours prior to metabolic rate measurements
  • Increased liver function tests
  • Metal objects that would interfere with the measurement of body composition /magnetic resonance spectroscopy such as implanted rods, surgical clips, etc
  • Any New York Heart Association class of congestive heart failure
  • History of deep vein thrombosis or pulmonary embolism
  • Significant varicose veins
  • Abnormal blood count/Anemia, or blood donation within the last 2 months
  • Major surgery on the abdomen, pelvis, or lower extremities within previous 3 months
  • Bariatric surgery or liposuction within the previous 3 years
  • Cancer (active malignancy with or without concurrent chemotherapy)
  • Rheumatoid disease
  • Bypass graft in limb
  • Known genetic factor (Factor V Leiden, etc) or hypercoagulable state
  • Diagnosed peripheral arterial or vascular disease, or intermittent claudication
  • Family history of primary deep vein thrombosis or pulmonary embolism
  • Peripheral neuropathy
  • Claustrophobia
  • Frequent nocturnal urination and/or sleep apnea
  • Presence of any condition that, in the opinion of the investigator, compromises participant safety or data integrity or the participants' ability to complete the training protocol

Applicable to Group 2

  • Gait problems
  • Major Depression
  • Presence of an eating disorder or eating attitudes/behaviors that could interfere with the study completion
  • Unwilling or unable to complete the protocol

Applicable to Group 3

  • HbA1c ≥ 6.5% (O)

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1 - Regular exercise
Alternate interval training and aerobic training and exercise
Behavioral: Exercise
A 5-minute warm-up and a 5-minute cool-down prior to and following each exercise session, respectively. There will be alternating days of interval training and aerobic training. The interval training will be performed on an upright stationary bike, while the aerobic training will be performed on a treadmill. The interval training will consist of five-minute bouts of higher intensity alternated with 4 minutes of lower intensity for a total duration of 45 minutes. Intensity will increase each week. The aerobic training component will be fixed at a moderate intensity, but will increase in duration each week from 45 minutes to 75 minutes to 90 minutes during the third and final week.
No Intervention: Group 2 - Athlete exercise
Athletes are not given any intervention
No Intervention: Group 3 - Obese No Exercise
The Obese group will not receive intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure change in mitochondrial capacity
Time Frame: Baseline (Day -6), Day 18

The difference will be measured in obese, lean and athletic participants.

The Phosphocreatine (PCr) recovery time constant and the PCr level in oxygenated muscle at rest will be used to calculate maximum mitochondrial capacity.
Baseline (Day -6), Day 18

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure change of expression of proteins
Time Frame: Baseline (Day -6), Day 0, Day 5, Day 12, Day 18

The difference will be measured in obese, lean and athletic participants.

This will be taken from muscle biopsy and/or blood plasma samples obtained at baseline, before and after exercise.
Baseline (Day -6), Day 0, Day 5, Day 12, Day 18
Measure change in mRNA/miRNA levels
Time Frame: Baseline (Day -6), Day 0, Day 5, Day 12, Day 18

The difference will be measured in obese, lean and athletic participants.

This will be taken from muscle biopsy and/or blood plasma samples obtained at baseline, before and after exercise.
Baseline (Day -6), Day 0, Day 5, Day 12, Day 18

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AdventHealth Translational Research Institute

Collaborators

Takeda
Sanford-Burnham Medical Research Institute

Investigators

  • Principal Investigator: Steven R Smith, MD, Translational Research Institute for Metabolism and Diabetes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

July 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

July 24, 2013

First Submitted That Met QC Criteria

July 25, 2013

First Posted (Estimated)

July 30, 2013

Study Record Updates

Last Update Posted (Estimated)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRIMDFH 460196

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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