NCT03697382

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

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

September 25, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

September 29, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 5, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2020

Completed
Last Updated

September 30, 2021

Status Verified

September 1, 2021

Enrollment Period

1.4 years

First QC Date

September 25, 2018

Last Update Submit

September 29, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 6-Hour Plasma Triglyceride Area Under the Curve

    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)

  • 6-Hour Plasma Insulin Area Under the Curve

    6-hours

  • 6-Hour Plasma Glucose Area Under the Curve

    6-hours

Study Arms (3)

Very Low Steps

EXPERIMENTAL

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.

Behavioral: Very Low Steps

Low Steps

EXPERIMENTAL

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.

Behavioral: Low Steps

Moderate Steps

EXPERIMENTAL

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.

Behavioral: Moderate Steps

Interventions

Very Low StepsBEHAVIORAL

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.

Very Low Steps
Low StepsBEHAVIORAL

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.

Low Steps
Moderate StepsBEHAVIORAL

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.

Moderate Steps

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
  • 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

Related Publications (1)

  • Burton HM, Coyle EF. Daily Step Count and Postprandial Fat Metabolism. Med Sci Sports Exerc. 2021 Feb 1;53(2):333-340. doi: 10.1249/MSS.0000000000002486.

MeSH Terms

Conditions

AtherosclerosisMetabolic Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

  • Heath Burton, M.S.

    University of Texas at Austin

    PRINCIPAL INVESTIGATOR
  • 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
Model Details: Subjects will complete three experimental conditions which include 2 days of reduced step count (2,500, 5,000, and 7,500 steps/day) with 1-hour of exercise at 65% VO2max.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 25, 2018

First Posted

October 5, 2018

Study Start

September 29, 2018

Primary Completion

February 15, 2020

Study Completion

May 31, 2020

Last Updated

September 30, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations