- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03856606
The Effects of Interrupting Prolonged Sitting With Intermittent Exercise on Postprandial Lipemia
February 25, 2019 updated by: Edward F. Coyle, University of Texas at Austin
The purpose of this study is to investigate the effect of interrupting prolong sedentary behavior with interval exercise on postprandial metabolism following a high fat glucose tolerance test.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
All subjects complete two trials in a randomized crossover design, with each trial occurring over 4 days with a minimum of seven days between trials.
The first two days of each trial serve as a control period allowing for familiarization and the control of physical activity and calorie consumption prior to the intervention.
Following each control period, subjects then perform one of the interventions on Day 3. The interventions consist of either eight-hours of prolonged sitting, or eight hours of sitting interrupted every hour by five sprints lasting 4 seconds each using the interval exercise.
On day 4, all subjects will undergo a high fat glucose tolerance test to determine the body's ability to clear triglycerides from the blood as well as insulin/glucose response and substrate oxidation.
Blood samples will be assayed for the previously mentioned substances and postprandial gas collection will be analyzed via indirect calorimetry.
Study Type
Interventional
Enrollment (Actual)
8
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
-
-
Texas
-
Austin, Texas, United States, 78712
- University of Texas at Austin Human Performance Laboratory
-
-
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
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
-
Exclusion Criteria:
- cardiovascular problems (e.g. pre-existing heart issues, coronary artery disease, hypertension, etc.)
- respiratory problems
- musculoskeletal problems that prevent prolonged sitting or exercise
- susceptibility to fainting
- Pregnancy
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: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Prolonged sitting without exercise
Subjects will be asked to undergo prolonged sitting (~14 hours) of 1 day and will not be asked to perform interval exercise.
|
Subjects will have a 2-day control period during which step count and diet will be controlled for and recreated for the other trial.
Following this 2-day period, they will undergo the prolonged sitting trial.
Day 4 will consist of the lipid tolerance test to determine the ability of the body to clear triglycerides.
|
Experimental: Prolonged sitting with interval exercise
Subjects will be asked to undergo prolonged sitting (~14 hours) of 1 day and will be asked to perform interval exercise every hour on the hour.
|
Subjects will have a 2-day control period during which step count and diet will be controlled for and recreated for the other trial.
Following this 2-day period, they will undergo a prolonged sit which with will be broken up every hour on the hour by a small bout of interval exercise.
Day 4 will consist of the lipid tolerance test to determine the ability of the body to clear triglycerides.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasma Triglycerides
Time Frame: 6-hours
|
Areas under the curve for triglyceride concentration will be calculated for hourly samples from a 6-hour lipid tolerance test
|
6-hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasma Insulin
Time Frame: 6-hours
|
Areas under the curve for insulin concentration will be calculated for hourly samples from a 6-hour lipid tolerance test
|
6-hours
|
Plasma Glucose
Time Frame: 6-hours
|
Areas under the curve for glucose concentration will be calculated for hourly samples from a 6-hour lipid tolerance test
|
6-hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Edward F Coyle, Ph.D., University of Texas at Austin
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)
February 20, 2018
Primary Completion (Actual)
July 8, 2018
Study Completion (Actual)
July 8, 2018
Study Registration Dates
First Submitted
February 25, 2019
First Submitted That Met QC Criteria
February 25, 2019
First Posted (Actual)
February 27, 2019
Study Record Updates
Last Update Posted (Actual)
February 27, 2019
Last Update Submitted That Met QC Criteria
February 25, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-11-0141
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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