NCT03856606

Brief Summary

The purpose of this study is to investigate the effect of interrupting prolong sedentary behavior with interval exercise on postprandial metabolism following a high fat glucose tolerance test.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

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

Study Start

First participant enrolled

February 20, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 27, 2019

Completed
Last Updated

February 27, 2019

Status Verified

February 1, 2019

Enrollment Period

5 months

First QC Date

February 25, 2019

Last Update Submit

February 25, 2019

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 without exercise

EXPERIMENTAL

Subjects will be asked to undergo prolonged sitting (\~14 hours) of 1 day and will not be asked to perform interval exercise.

Behavioral: Prolonged sitting without exercise

Prolonged sitting with interval exercise

EXPERIMENTAL

Subjects will be asked to undergo prolonged sitting (\~14 hours) of 1 day and will be asked to perform interval exercise every hour on the hour.

Behavioral: Prolonged sitting with interval 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. Day 4 will consist of the lipid tolerance test to determine the ability of the body to clear triglycerides.

Prolonged sitting without 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 a prolonged sit which with will be broken up every hour on the hour by a small bout of interval exercise. Day 4 will consist of the lipid tolerance test to determine the ability of the body to clear triglycerides.

Prolonged sitting with interval 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
  • susceptibility to fainting
  • Pregnancy

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

Metabolic SyndromeAtherosclerosisInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Interventions

Exercise

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Edward F Coyle, Ph.D.

    University of Texas at Austin

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

February 25, 2019

First Posted

February 27, 2019

Study Start

February 20, 2018

Primary Completion

July 8, 2018

Study Completion

July 8, 2018

Last Updated

February 27, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations