- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05135234
Developing a Physiological Understanding of High Duration Activity
Adaptive Effects of Very Light Physical Activity on Metabolism
When muscles are not contracting, the local energy demand by muscle and use of specific fuels used to produce energy by oxidative metabolism are minimal. The time people spend sitting inactive (sedentary time) typically comprises more than half of the day. This sedentary behavior is associated with elevated risk of diabetes, cardiovascular diseases, some cancers, and multiple conditions leading to poor aging.
From a progressive series of experiments, the driving goal is to develop a physiological method for sustaining contractile activity via oxidative metabolism over more time than is possible by traditional exercise (hours, not minutes per day).
Developing a physiological method suitable of prolonged muscular activity for ordinary people (who are often unfit) requires gaining fundamental insights about muscle biology and biomechanics. This also entails a careful appreciation of the ability to isolate specific muscles in the leg during controlled movements, such as the soleus muscle during isolated plantarflexion. This includes quantifying specific biological processes that are directly responsive to elevated skeletal muscle recruitment. The investigators will focus on movement that is safe and practical for ordinary people to do given their high amount of daily sitting time.
This includes developing methods to optimally raise muscle contractile activity, in a way that is not limited by fatigue, and is feasible throughout as many minutes of the day as possible safely. This also requires development of methodologies to quantify specific muscular activity, rather than generalized body movement.
There is a need to learn how much people can increase muscle metabolism by physical activity that is perceived to them as being light effort. It is important to learn if this impacts systemic metabolic processes under experimental conditions over a short term time span in order to avoid confounding influences of changes in body weight or other factors.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
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Houston, Texas, United States, 77204
- University of Houston
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age must be 18 years or older
- Able to fast overnight
- Can maintain diet, medications, and sleep habits between each of the testing visits.
- Lifestyle is consistent with participation in a study evaluating reductions of inactivity (defined by sitting at a low metabolic rate because of minimal muscular activity)
- Willing and able to wear small wearable activity monitors under their clothes as instructed.
- No plans to start a new diet or exercise program if enrolled in the present study.
Exclusion Criteria:
- Practical barriers to completing the study, such as plans to move, or work, or family commitments.
- Plans to change lifestyle during the present study.
- Have physical, vocational, or reasons that prohibit ordinary sitting behaviors present in the modern world.
- Currently dieting to change body weight, or have eating disorder.
- Are pregnant or plan to become pregnant.
- Taking medications that affect bleeding (ie anticoagulants).
- Allergy to lidocaine excludes biopsy component of study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Muscular Exercise
Increased level of low effort muscular activity
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Sedentary time (muscular inactivity when sitting) will be replaced with low effort muscular activity
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oxygen cost of isolated muscle contractions
Time Frame: Acute contractile activity (at least 3 minutes)
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The energetics of isolated muscle contractions will be described relative to the distinct biomechanics of different types of muscular movement
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Acute contractile activity (at least 3 minutes)
|
Fatigue time during muscle group specific contractile activity
Time Frame: Acute measurements less than 1 day. The exact duration is an individual response that is an outcome of unknown minutes consistent with the fatiguability of different movements.
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Determinants of muscular endurance as a function of recruitment intensity
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Acute measurements less than 1 day. The exact duration is an individual response that is an outcome of unknown minutes consistent with the fatiguability of different movements.
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Change in postprandial glucose regulation
Time Frame: The change through the completion of the postprandial period, an average of 180 minutes
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Glucose concentration response during the postprandial period after an oral glucose tolerance test
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The change through the completion of the postprandial period, an average of 180 minutes
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Change in very low density lipoprotein (VLDL) - Triglyceride
Time Frame: The change through the completion of an acute fasting period, approximately 8-12 hours
|
The concentration of triglyceride in the plasma VLDL lipoprotein
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The change through the completion of an acute fasting period, approximately 8-12 hours
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The change in muscular inactivity time as a result of isolated contractile activity of the soleus
Time Frame: Throughout the waking day (~16 hours).
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Development of an objective method(s) to quantify sedentary vs. non sedentary time.
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Throughout the waking day (~16 hours).
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Angiopoietin-like protein 4
Time Frame: The acute time course during the onset of muscular inactivity and contractile activity within 30 minutes to 8 hours
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One of the molecular determinants of lipoprotein lipase regulation
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The acute time course during the onset of muscular inactivity and contractile activity within 30 minutes to 8 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recruited mass of the soleus and other muscles in the triceps surae during isolated plantarflexion
Time Frame: During acute contractile activity of at least 3 minutes
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grams of the soleus, lateral gastrocnemius and medial gastrocnemius
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During acute contractile activity of at least 3 minutes
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Electrical activity of muscle, Electromyography (EMG)
Time Frame: At least 3 minute recording periods
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The activation of the triceps surae muscle group
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At least 3 minute recording periods
|
Local rate of oxygen consumption of working muscle
Time Frame: Steady-state measurements taken for ~6 continuous minutes of contractile activity
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oxygen cost per kg muscle during isolated contractile activity and treadmill exercise
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Steady-state measurements taken for ~6 continuous minutes of contractile activity
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The ratio of carbohydrate vs. fat oxidation
Time Frame: Acute responses within less than 24 hours.
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The change in the ratio of the fat vs. carbohydrate utilization during acute contractile activity
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Acute responses within less than 24 hours.
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Plasma insulin change
Time Frame: The change through the completion of the postprandial period, an average of 180 minutes
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Plasma insulin concentration
|
The change through the completion of the postprandial period, an average of 180 minutes
|
Sedentary/muscular inactivity time vs. intermittent non-seated standing behaviors
Time Frame: Throughout the waking day (~16 hours).
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Sedentary time is defined as sitting with a low rate of muscle metabolism due to inactivity
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Throughout the waking day (~16 hours).
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apolipoprotein B100 concentration change
Time Frame: After at least 4 weeks of increased contractile activity
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Biochemical measurement in units of mg per dL
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After at least 4 weeks of increased contractile activity
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Change in the concentration of GlycA (this is not an acronym; it is a biomarker of inflammation)
Time Frame: After at least 4 weeks of increased contractile activity
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Nuclear magnetic resonance in units of umol per L
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After at least 4 weeks of increased contractile activity
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Small dense LDL concentration change
Time Frame: After at least 4 weeks of increased contractile activity
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This is an atherogenic lipoprotein particle
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After at least 4 weeks of increased contractile activity
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Complement component 3 (C3) concentration change
Time Frame: After at least 4 weeks of increased contractile activity
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This is an acute phase protein, a marker of inflammation
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After at least 4 weeks of increased contractile activity
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Ferritin concentration change
Time Frame: After at least 4 weeks of increased contractile activity
|
This is a biomarker related to inflammation and diabetes
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After at least 4 weeks of increased contractile activity
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Plasma triglyceride concentration change
Time Frame: After at least 4 weeks of increased contractile activity
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Triglyceride concentration in VLDL and non-VLDL particles
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After at least 4 weeks of increased contractile activity
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Marc T Hamilton, Ph.D., University of Houston
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15463-01
- University of Houston (Other Grant/Funding Number: University of Houston)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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