Identification of Novel Skeletal Muscle-derived Factors That Promote Lipid Oxidation (Columbus)
Columbus
1 other identifier
interventional
56
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable obesity
Started Jul 2013
Longer than P75 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 24, 2013
CompletedFirst Posted
Study publicly available on registry
July 30, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
ExpectedMarch 30, 2026
March 1, 2026
1.4 years
July 24, 2013
March 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Measure change in mitochondrial capacity
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 Outcomes (2)
Measure change of expression of proteins
Baseline (Day -6), Day 0, Day 5, Day 12, Day 18
Measure change in mRNA/miRNA levels
Baseline (Day -6), Day 0, Day 5, Day 12, Day 18
Study Arms (3)
Group 1 - Regular exercise
EXPERIMENTALAlternate interval training and aerobic training and exercise
Group 2 - Athlete exercise
NO INTERVENTIONAthletes are not given any intervention
Group 3 - Obese No Exercise
NO INTERVENTIONThe Obese group will not receive intervention
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +23 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AdventHealth Translational Research Institutelead
- Sanford-Burnham Medical Research Institutecollaborator
- Takedacollaborator
Study Sites (1)
Translational Research Institute for Metabolism and Diabetes
Orlando, Florida, 32804, United States
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Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lauren Sparks, PhD
Translational Research Institute for Metabolism and Diabetes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 24, 2013
First Posted
July 30, 2013
Study Start
July 1, 2013
Primary Completion
December 1, 2014
Study Completion (Estimated)
December 1, 2026
Last Updated
March 30, 2026
Record last verified: 2026-03