- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03697382
Effect of Daily Steps on Fat Metabolism
September 29, 2021 updated by: Edward F. Coyle, University of Texas at Austin
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
12
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
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
- Obesity
- 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: Very Low Steps
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.
|
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.
|
Experimental: Low Steps
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.
|
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.
|
Experimental: Moderate Steps
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6-hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
6-Hour Plasma Insulin Area Under the Curve
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
|
6-Hour Plasma Glucose Area Under the Curve
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
- Principal Investigator: Heath Burton, M.S., University of Texas at Austin
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
September 29, 2018
Primary Completion (Actual)
February 15, 2020
Study Completion (Actual)
May 31, 2020
Study Registration Dates
First Submitted
September 25, 2018
First Submitted That Met QC Criteria
October 3, 2018
First Posted (Actual)
October 5, 2018
Study Record Updates
Last Update Posted (Actual)
September 30, 2021
Last Update Submitted That Met QC Criteria
September 29, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-08-0031
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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