- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03098446
The Effect of Sitting and Moderate Exercise on Plasma Triglyceride Elevation After a Meal
October 3, 2018 updated by: Edward F. Coyle, University of Texas at Austin
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
10
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
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
-
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
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
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Prolonged sitting with exercise
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.
|
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.
|
|
EXPERIMENTAL: Prolonged sitting without exercise
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
6-hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Plasma Insulin
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
|
|
Plasma Glucose
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
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)
April 8, 2017
Primary Completion (ACTUAL)
August 11, 2017
Study Completion (ACTUAL)
August 11, 2017
Study Registration Dates
First Submitted
March 27, 2017
First Submitted That Met QC Criteria
March 27, 2017
First Posted (ACTUAL)
March 31, 2017
Study Record Updates
Last Update Posted (ACTUAL)
October 5, 2018
Last Update Submitted That Met QC Criteria
October 3, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-12-0022
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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