- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04241081
Interrupting Prolonged Sitting With Periodic Interval Exercise: Effect on Postprandial Lipemia
January 21, 2020 updated by: University of Texas at Austin
Investigating the effects of interrupting various lengths of prolonged sitting with bike sprints on post prandial lipemia the next day.
We will conduct three trials, one control, one with two-hour sitting intervals (total of 4 bouts of bike sprints) and one with 6-hour sitting intervals I total of two bouts of bike sprints).
A milkshake high fat tolerance test will be conducted the next day and whole body fat oxidation as well as triglyceride area under the curve will be measured every hour for the duration of the 6-hour test.
Study Overview
Status
Unknown
Conditions
Study Type
Interventional
Enrollment (Anticipated)
15
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 Contact
- Name: Rebecca braden, BS
- Phone Number: 4422156656
- Email: rebecca.braden@utexas.edu
Study Contact Backup
- Name: Edward Coyle, PhD
- Phone Number: 512 471 8596
- Email: coyle@austin.utexas.edu
Study Locations
-
-
Texas
-
Austin, Texas, United States, 78705
- University of Texas, Austin
-
Contact:
- Edward Coyle, PhD
- Phone Number: 512 471 8596
- Email: coyle@austin.utexas.edu
-
Contact:
- Rebecca Braden, BS
- Phone Number: 442-215-6656
- Email: rebecca.braden@utexas.edu
-
-
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 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Inactive or recreational healthy adults aged 18-65 years old.
Exclusion Criteria:
- Lactose intolerance, cardiovascular or metabolic diagnoses, medications for cardiovascular or metabolic diagnoses, orthopedic issues barring cycling.
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: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: Control group-no exercise
A no-exercise control.
Must maintain <4,500 steps per day for 3 consecutive days followed by a high fat tolerance test on day 4.
|
|
EXPERIMENTAL: Exercise intervention 1
Two consecutive days of <4,500 steps per day followed by an intervention day on day 3. Intervention day consists of interrupting 8-hour sit with bike sprint protocol every 2 hours.
Participants must aim to maintain <2,500 steps on intervention day.
A high fat tolerance test will be performed the following day on day 4.
|
This is a behavioral intervention designed to determine the effect of breaking up prolonged bouts of sitting every 2 hours and every 6 hours with 5 sets of 4 second bouts of maximum effort bicycle ergometer accelerations compared to sitting alone on the blood triglyceride response and whole body fat oxidation after a high fat meal.
|
EXPERIMENTAL: Exercise intervention 2
Two consecutive days of <4,500 steps per day followed by an intervention day.
Intervention day consists of interrupting 8-hour sit with bike sprint protocol every 6 hours.
Participants must aim to maintain <2,500 steps on intervention day.
A high fat tolerance test will be performed the following day on day 4.
|
This is a behavioral intervention designed to determine the effect of breaking up prolonged bouts of sitting every 2 hours and every 6 hours with 5 sets of 4 second bouts of maximum effort bicycle ergometer accelerations compared to sitting alone on the blood triglyceride response and whole body fat oxidation after a high fat meal.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Triglyceride area under the curve
Time Frame: 6 hour long high fat tolerance test
|
Blood measurements baseline and every hour during a high fat tolerance test.
|
6 hour long high fat tolerance test
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Whole body fat oxidation
Time Frame: 10 min, baseline, 2 hours post ingestion of shake, 4 hours, 6 hours.
|
Expired gas collection and measurement of expired gas concentrations in mass spectrometer, baseline and every two hours during high fat tolerance test.
|
10 min, baseline, 2 hours post ingestion of shake, 4 hours, 6 hours.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (ANTICIPATED)
January 1, 2020
Primary Completion (ANTICIPATED)
May 1, 2020
Study Completion (ANTICIPATED)
May 1, 2020
Study Registration Dates
First Submitted
January 21, 2020
First Submitted That Met QC Criteria
January 21, 2020
First Posted (ACTUAL)
January 27, 2020
Study Record Updates
Last Update Posted (ACTUAL)
January 27, 2020
Last Update Submitted That Met QC Criteria
January 21, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-10-0091
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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