AtherosclerosisNCT03697382
Effect of Daily Steps on Fat Metabolism
A study testing Very Low Steps, Low Steps and Moderate Steps in people with Atherosclerosis and Metabolic Syndrome, run by University of Texas at Austin at 1 site in United States.
Trial summary
Reduced ambulatory activity has been shown to effect the response to a high fat tolerance test (HFTT) after acute exercise. This study will evaluate the effect of varying levels of daily ambulation on response to a HFTT after an acute aerobic exercise bout. 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?
- Very Low Steps, Low Steps and Moderate Steps
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2018to 31 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
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
- Pregnancy
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
Official title: Effect of Daily Ambulatory Activity on the Responses to Acute Aerobic Exercise.
Reduced ambulatory activity has been shown to effect the response to a high fat tolerance test (HFTT) after acute exercise. This study will evaluate the effect of varying levels of daily ambulation on response to a HFTT after an acute aerobic exercise bout.
- Conditions
- Atherosclerosis, Metabolic Syndrome
- Being tested
- Very Low Steps, Low Steps, Moderate Steps
- 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.
Very Low StepsBehavioural
Subjects will have a 2-day control period during which step count and diet will be controlled for and recreated for the other trials. Following this 2-day period, they will undergo the Very Low Stepping trial with the acute bout of exercise on day 2. Day 3 will consist of the lipid tolerance test to determine the ability of the body to clear triglycerides.
Low StepsBehavioural
Subjects will have a 2-day control period during which step count and diet will be controlled for and recreated for the other trials. Following this 2-day period, they will undergo the Low Stepping trial with the acute bout of exercise on day 2. Day 3 will consist of the lipid tolerance test to determine the ability of the body to clear triglycerides.
Moderate StepsBehavioural
Subjects will have a 2-day control period during which step count and diet will be controlled for and recreated for the other trials. Following this 2-day period, they will undergo the Moderate Stepping trial with the acute bout of exercise on day 2. Day 3 will consist of the lipid tolerance test to determine the ability of the body to clear triglycerides.
| Study group | Role | What they receive |
|---|---|---|
| Very Low Steps | Experimental | Subjects will be asked to undergo reduced daily stepping to a level of 2,500 steps/d for 2 days. On the evening of day 2, they will be asked to run at 65% of VO2max for 1-hour. Receives: Behavioral: Very Low Steps |
| Low Steps | Experimental | Subjects will be asked to undergo reduced daily stepping to a level of 5,000 steps/d for 2 days. On the evening of day 2, they will be asked to run at 65% of VO2max for 1-hour. Receives: Behavioral: Low Steps |
| Moderate Steps | Experimental | Subjects will be asked to undergo reduced daily stepping to a level of 7,500 steps/d for 2 days. On the evening of day 2, they will be asked to run at 65% of VO2max for 1-hour. Receives: Behavioral: Moderate Steps |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-Hour Plasma Triglyceride Area Under the Curve
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)
6-Hour Plasma Insulin Area Under the Curve
Areas under the curve for insulin concentration will be calculated for hourly samples from a 6-hour lipid tolerance test
Measured: 6-hours
6-Hour Plasma Glucose Area Under the Curve
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 posted5 Oct 2018
- Study start29 Sep 2018
- Primary completion15 Feb 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 complete three experimental conditions which include 2 days of reduced step count (2,500, 5,000, and 7,500 steps/day) with 1-hour of exercise at 65% VO2max.
- Masking
- None (open label)
- Enrolment
- 12 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
- Investigators
- Heath Burton, M.S., Principal investigator, University of Texas at AustinEdward F Coyle, Ph.D., Study director, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03697382
- Sponsor's protocol ID
- 2018-08-0031
- Status last verified
- Sep 2021
- First submitted
- 25 Sep 2018
- Last updated
- 30 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Burton HM, Coyle EF. Daily Step Count and Postprandial Fat Metabolism. Med Sci Sports Exerc. 2021 Feb 1;53(2):333-340. doi: 10.1249/MSS.0000000000002486.
PubMed 33105387
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Daily Ambulatory Activity on the Responses to Acute Aerobic Exercise.
- ClinicalTrials.gov ID
- NCT03697382
- Acronym / sponsor ID
- 2018-08-0031
- Conditions
- Atherosclerosis, Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 29 Sep 2018 (actual)
- Primary completion
- 15 Feb 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 5 Oct 2018 (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.
Reduced ambulatory activity has been shown to effect the response to a high fat tolerance test (HFTT) after acute exercise. This study will evaluate the effect of varying levels of daily ambulation on response to a HFTT after an acute aerobic exercise bout.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Subjects will complete three experimental conditions which include 2 days of reduced step count (2,500, 5,000, and 7,500 steps/day) with 1-hour of exercise at 65% VO2max.
| Arm | Type | Receives |
|---|---|---|
| Very Low Steps | Experimental | Behavioral: Very Low StepsSubjects will be asked to undergo reduced daily stepping to a level of 2,500 steps/d for 2 days. On the evening of day 2, they will be asked to run at 65% of VO2max for 1-hour. |
| Low Steps | Experimental | Behavioral: Low StepsSubjects will be asked to undergo reduced daily stepping to a level of 5,000 steps/d for 2 days. On the evening of day 2, they will be asked to run at 65% of VO2max for 1-hour. |
| Moderate Steps | Experimental | Behavioral: Moderate StepsSubjects will be asked to undergo reduced daily stepping to a level of 7,500 steps/d for 2 days. On the evening of day 2, they will be asked to run at 65% of VO2max for 1-hour. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 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 |
|---|---|---|
| Very Low StepsSubjects will have a 2-day control period during which step count and diet will be controlled for and recreated for the other trials. Following this 2-day period, they will undergo the Very Low Stepping trial with the acute bout of exercise on day 2. Day 3 will consist of the lipid tolerance test to determine the ability of the body to clear triglycerides. | Behavioural | Very Low Steps |
| Low StepsSubjects will have a 2-day control period during which step count and diet will be controlled for and recreated for the other trials. Following this 2-day period, they will undergo the Low Stepping trial with the acute bout of exercise on day 2. Day 3 will consist of the lipid tolerance test to determine the ability of the body to clear triglycerides. | Behavioural | Low Steps |
| Moderate StepsSubjects will have a 2-day control period during which step count and diet will be controlled for and recreated for the other trials. Following this 2-day period, they will undergo the Moderate Stepping trial with the acute bout of exercise on day 2. Day 3 will consist of the lipid tolerance test to determine the ability of the body to clear triglycerides. | Behavioural | Moderate Steps |
Primary outcome
6-Hour Plasma Triglyceride Area Under the Curve
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
6-Hour Plasma Insulin Area Under the Curve
Time frame: 6-hours
6-Hour Plasma Glucose Area Under the Curve
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 30 Sep 2021.
- Derived from this study: PubMed 33105387Burton HM, Coyle EF. Daily Step Count and Postprandial Fat Metabolism. Med Sci Sports Exerc. 2021 Feb 1;53(2):333-340. doi: 10.1249/MSS.0000000000002486.
- 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.
Heath Burton, M.S. principal investigator
University of Texas at Austin
Edward F Coyle, Ph.D. study director
University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Very Low Steps, Low Steps and Moderate Steps 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 0 inclusion and 6 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 30 Sep 2021. 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?
6-Hour Plasma Triglyceride Area Under the Curve (time frame: 6-hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03697382, which also lists 1 linked publication.
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 30 Sep 2021.