Sedentary BehaviorNCT04241081
Interrupting Prolonged Sitting With Periodic Interval Exercise: Effect on Postprandial Lipemia
A study testing Interrupting Prolonged Sitting with Periodic Interval Exercise: Effect on Postprandial Lipemia in people with Sedentary Behavior and Hypertriglyceridemia, run by University of Texas at Austin at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary Behavior, Hypertriglyceridemia
- What is being tested?
- Interrupting Prolonged Sitting with Periodic Interval Exercise: Effect on Postprandial Lipemia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2020to May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Inactive or recreational healthy adults aged 18-65 years old.
Who cannot join
- Lactose intolerance, cardiovascular or metabolic diagnoses, medications for cardiovascular or metabolic diagnoses, orthopedic issues barring cycling.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas, Austin
Austin, Texas, 78705
Rebecca Braden, BS, 442-215-6656, rebecca.braden@utexas.edu
Edward Coyle, PhD, 512 471 8596, coyle@austin.utexas.edu
About this study
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.
- Conditions
- Sedentary Behavior, Hypertriglyceridemia
- Being tested
- Interrupting Prolonged Sitting with Periodic Interval Exercise: Effect on Postprandial Lipemia
- Medical subject headings
- Sedentary Behavior, Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interrupting Prolonged Sitting with Periodic Interval Exercise: Effect on Postprandial LipemiaBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group-no exercise | No intervention | 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. |
| Exercise intervention 1 | Experimental | 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. Receives: Behavioral: Interrupting Prolonged Sitting with Periodic Interval Exercise: Effect on Postprandial Lipemia |
| Exercise intervention 2 | Experimental | 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. Receives: Behavioral: Interrupting Prolonged Sitting with Periodic Interval Exercise: Effect on Postprandial Lipemia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Triglyceride area under the curve
Blood measurements baseline and every hour during a high fat tolerance test.
Measured: 6 hour long high fat tolerance test
Secondary outcomes (1)
Whole body fat oxidation
Expired gas collection and measurement of expired gas concentrations in mass spectrometer, baseline and every two hours during high fat tolerance test.
Measured: 10 min, baseline, 2 hours post ingestion of shake, 4 hours, 6 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study startJan 2020 (estimated)
- Primary completionMay 2020 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04241081
- Sponsor's protocol ID
- 2019-10-0091
- Status last verified
- Jan 2020
- First submitted
- 21 Jan 2020
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interrupting Prolonged Sitting With Periodic Interval Exercise: Effect on Postprandial Lipemia
- ClinicalTrials.gov ID
- NCT04241081
- Acronym / sponsor ID
- 2019-10-0091
- Conditions
- Sedentary Behavior, Hypertriglyceridemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- Jan 2020 (estimated)
- Primary completion
- May 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group-no exercise | No intervention | –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. |
| Exercise intervention 1 | Experimental | Behavioral: Interrupting Prolonged Sitting with Periodic Interval Exercise: Effect on Postprandial LipemiaTwo 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. |
| Exercise intervention 2 | Experimental | Behavioral: Interrupting Prolonged Sitting with Periodic Interval Exercise: Effect on Postprandial LipemiaTwo 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inactive or recreational healthy adults aged 18-65 years old.
Key exclusion criteria (1 listed)
- Lactose intolerance, cardiovascular or metabolic diagnoses, medications for cardiovascular or metabolic diagnoses, orthopedic issues barring cycling.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interrupting Prolonged Sitting with Periodic Interval Exercise: Effect on Postprandial LipemiaThis 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. | Behavioural | Exercise intervention 1, Exercise intervention 2 |
Primary outcome
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.
1 secondary outcome
Whole body fat oxidation
Time frame: 10 min, baseline, 2 hours post ingestion of shake, 4 hours, 6 hours.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interrupting Prolonged Sitting with Periodic Interval Exercise: Effect on Postprandial Lipemia in people with Sedentary Behavior and Hypertriglyceridemia, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rebecca braden, BS (4422156656, rebecca.braden@utexas.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Triglyceride area under the curve (time frame: 6 hour long high fat tolerance test). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.