AtherosclerosisNCT03098446
The Effect of Sitting and Moderate Exercise on Plasma Triglyceride Elevation After a Meal
A study testing Prolonged sitting with exercise and Prolonged sitting without exercise in people with Atherosclerosis and Metabolic Syndrome, run by University of Texas at Austin at 1 site in United States.
Trial summary
The purpose of this study is to investigate the effect of 4 days of sitting and moderate exercise on plasma triglyceride elevation after a meal. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis, Metabolic Syndrome
- What is being tested?
- Prolonged sitting with exercise and Prolonged sitting without exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2017to 11 Aug 2017
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- -
Who cannot join
- cardiovascular problems (e.g. pre-existing heart issues, coronary artery disease, hypertension, etc.)
- respiratory problems
- musculoskeletal problems that prevent prolonged sitting or exercise
- obesity
- susceptibility to fainting
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas at Austin Human Performance Laboratory
Austin, Texas, 78712
About this study
The purpose of this study is to investigate the effect of 4 days of sitting and moderate exercise on plasma triglyceride elevation after a meal.
Read the detailed description
Subjects will undergo three weeks (two intervention, one washout) of testing during which they will participate in two conditions: 1) prolonged sitting (~14-hours/day) with a 1-hour bout of acute exercise at 65% of pre-intervention VO2max and 2) prolonged sitting (~14-hours/day) without an acute bout of exercise. During each intervention week, subjects will have 2 days of dietary and activity control, followed by 4 days during which prolonged sitting will occur. On the evening of the 4th day, subjects in the exercise group will perform the acute bout of exercise. On day 5, all subjects will undergo a lipid 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.
- Conditions
- Atherosclerosis, Metabolic Syndrome
- Being tested
- Prolonged sitting with exercise, Prolonged sitting without exercise
- Medical subject headings
- Atherosclerosis, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged sitting with exerciseBehavioural
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 with the acute bout of exercise on day 4. Day 5 will consist of the lipid tolerance test to determine the ability of the body to clear triglycerides.
Prolonged sitting without exerciseBehavioural
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, but will not be asked to complete an acute bout of exercise on day 4. Day 5 will consist of the lipid tolerance test to determine the ability of the body to clear triglycerides.
| Study group | Role | What they receive |
|---|---|---|
| Prolonged sitting with exercise | Experimental | Subjects will be asked to undergo prolonged sitting (~14-hours/day) for 4 days. On the evening of day 4, they will be asked to run at 65% of VO2max for 1-hour. Receives: Behavioral: Prolonged sitting with exercise |
| Prolonged sitting without exercise | Experimental | Subjects will be asked to undergo prolonged sitting (~14-hours/day) for 4 days. Subjects will not be asked to complete the acute bout of exercise to serve as a control. Receives: Behavioral: Prolonged sitting without exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Triglycerides
Areas under the curve for triglyceride concentration will be calculated for hourly samples from a 6-hour lipid tolerance test
Measured: 6-hours
Secondary outcomes (2)
Plasma Insulin
Areas under the curve for insulin concentration will be calculated for hourly samples from a 6-hour lipid tolerance test
Measured: 6-hours
Plasma Glucose
Areas under the curve for glucose concentration will be calculated for hourly samples from a 6-hour lipid tolerance test
Measured: 6-hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2017
- Study start8 Apr 2017
- Primary completion11 Aug 2017
- Study completion11 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Subjects will be randomly assigned to either the sitting plus exercise or the sitting without exercise group and then, after a one week washout period, complete the other task.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edward F. Coyle, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03098446
- Sponsor's protocol ID
- 2016-12-0022
- Status last verified
- Oct 2018
- First submitted
- 27 Mar 2017
- Last updated
- 5 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sitting and Moderate Exercise on Plasma Triglyceride Elevation After a Meal
- ClinicalTrials.gov ID
- NCT03098446
- Acronym / sponsor ID
- 2016-12-0022
- Conditions
- Atherosclerosis, Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 8 Apr 2017 (actual)
- Primary completion
- 11 Aug 2017 (actual)
- Study completion
- 11 Aug 2017 (actual)
- First posted
- 31 Mar 2017 (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.
The purpose of this study is to investigate the effect of 4 days of sitting and moderate exercise on plasma triglyceride elevation after a meal.
Detailed description
Subjects will undergo three weeks (two intervention, one washout) of testing during which they will participate in two conditions: 1) prolonged sitting (~14-hours/day) with a 1-hour bout of acute exercise at 65% of pre-intervention VO2max and 2) prolonged sitting (~14-hours/day) without an acute bout of exercise. During each intervention week, subjects will have 2 days of dietary and activity control, followed by 4 days during which prolonged sitting will occur. On the evening of the 4th day, subjects in the exercise group will perform the acute bout of exercise. On day 5, all subjects will undergo a lipid 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects will be randomly assigned to either the sitting plus exercise or the sitting without exercise group and then, after a one week washout period, complete the other task.
| Arm | Type | Receives |
|---|---|---|
| Prolonged sitting with exercise | Experimental | Behavioral: Prolonged sitting with exerciseSubjects will be asked to undergo prolonged sitting (~14-hours/day) for 4 days. On the evening of day 4, they will be asked to run at 65% of VO2max for 1-hour. |
| Prolonged sitting without exercise | Experimental | Behavioral: Prolonged sitting without exerciseSubjects will be asked to undergo prolonged sitting (~14-hours/day) for 4 days. Subjects will not be asked to complete the acute bout of exercise to serve as a control. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (5 listed)
- cardiovascular problems (e.g. pre-existing heart issues, coronary artery disease, hypertension, etc.)
- respiratory problems
- musculoskeletal problems that prevent prolonged sitting or exercise
- obesity
- susceptibility to fainting
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 |
|---|---|---|
| Prolonged sitting with exerciseSubjects 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 with the acute bout of exercise on day 4. Day 5 will consist of the lipid tolerance test to determine the ability of the body to clear triglycerides. | Behavioural | Prolonged sitting with exercise |
| Prolonged sitting without exerciseSubjects 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, but will not be asked to complete an acute bout of exercise on day 4. Day 5 will consist of the lipid tolerance test to determine the ability of the body to clear triglycerides. | Behavioural | Prolonged sitting without exercise |
Primary outcome
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
2 secondary outcomes
Plasma Insulin
Time frame: 6-hours
Plasma Glucose
Time frame: 6-hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolonged sitting with exercise and Prolonged sitting without exercise in people with Atherosclerosis and Metabolic Syndrome, 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 5 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: finished, as of the sponsor's last update on 5 Oct 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma Triglycerides (time frame: 6-hours). 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 5 Oct 2018.