The Effect of Sitting and Moderate Exercise on Plasma Triglyceride Elevation After a Meal
Primary Purpose
Atherosclerosis, Metabolic Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prolonged sitting with exercise
Prolonged sitting without exercise
Sponsored by
About this trial
This is an interventional prevention trial for Atherosclerosis
Eligibility Criteria
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
Sites / Locations
- University of Texas at Austin Human Performance Laboratory
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Prolonged sitting with exercise
Prolonged sitting without exercise
Arm Description
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 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.
Outcomes
Primary Outcome Measures
Plasma Triglycerides
Areas under the curve for triglyceride concentration will be calculated for hourly samples from a 6-hour lipid tolerance test
Secondary Outcome Measures
Plasma Insulin
Areas under the curve for insulin concentration will be calculated for hourly samples from a 6-hour lipid tolerance test
Plasma Glucose
Areas under the curve for glucose concentration will be calculated for hourly samples from a 6-hour lipid tolerance test
Full Information
NCT ID
NCT03098446
First Posted
March 27, 2017
Last Updated
October 3, 2018
Sponsor
University of Texas at Austin
1. Study Identification
Unique Protocol Identification Number
NCT03098446
Brief Title
The Effect of Sitting and Moderate Exercise on Plasma Triglyceride Elevation After a Meal
Official Title
The Effect of Sitting and Moderate Exercise on Plasma Triglyceride Elevation After a Meal
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
April 8, 2017 (Actual)
Primary Completion Date
August 11, 2017 (Actual)
Study Completion Date
August 11, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas at Austin
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis, Metabolic Syndrome
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prolonged sitting with exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Prolonged sitting without exercise
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Prolonged sitting with exercise
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Prolonged sitting without exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Plasma Triglycerides
Description
Areas under the curve for triglyceride concentration will be calculated for hourly samples from a 6-hour lipid tolerance test
Time Frame
6-hours
Secondary Outcome Measure Information:
Title
Plasma Insulin
Description
Areas under the curve for insulin concentration will be calculated for hourly samples from a 6-hour lipid tolerance test
Time Frame
6-hours
Title
Plasma Glucose
Description
Areas under the curve for glucose concentration will be calculated for hourly samples from a 6-hour lipid tolerance test
Time Frame
6-hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
University of Texas at Austin Human Performance Laboratory
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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The Effect of Sitting and Moderate Exercise on Plasma Triglyceride Elevation After a Meal
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