NCT03098446

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 31, 2017

Completed
8 days until next milestone

Study Start

First participant enrolled

April 8, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2017

Completed
Last Updated

October 5, 2018

Status Verified

October 1, 2018

Enrollment Period

4 months

First QC Date

March 27, 2017

Last Update Submit

October 3, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Plasma Triglycerides

    Areas under the curve for triglyceride concentration will be calculated for hourly samples from a 6-hour lipid tolerance test

    6-hours

Secondary Outcomes (2)

  • Plasma Insulin

    6-hours

  • Plasma Glucose

    6-hours

Study Arms (2)

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.

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.

Behavioral: Prolonged sitting without exercise

Interventions

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 with exercise

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.

Prolonged sitting without exercise

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas at Austin Human Performance Laboratory

Austin, Texas, 78712, United States

Location

MeSH Terms

Conditions

AtherosclerosisMetabolic Syndrome

Interventions

Exercise

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 27, 2017

First Posted

March 31, 2017

Study Start

April 8, 2017

Primary Completion

August 11, 2017

Study Completion

August 11, 2017

Last Updated

October 5, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations