Effect of Daily Steps on Fat Metabolism

Sponsor

University of Texas at Austin (Other)

Overall Status

Completed

CT.gov ID

NCT03697382

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atherosclerosis Metabolic Syndrome	Behavioral: Very Low Steps Behavioral: Low Steps Behavioral: Moderate Steps	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

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.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.

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Effect of Daily Ambulatory Activity on the Responses to Acute Aerobic Exercise.

Actual Study Start Date :

Sep 29, 2018

Actual Primary Completion Date :

Feb 15, 2020

Actual Study Completion Date :

May 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Very Low Steps 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 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.
Experimental: Low Steps 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 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.
Experimental: Moderate Steps 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 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.

Arm

Intervention/Treatment

Experimental: Very Low Steps

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

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.

Experimental: Low Steps

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

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.

Experimental: Moderate Steps

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

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.

Outcome Measures

Primary Outcome Measures

6-Hour Plasma Triglyceride Area Under the Curve [6-hours]
Areas under the curve for triglyceride concentration will be calculated for hourly samples from a 6-hour lipid tolerance test.

Secondary Outcome Measures

6-Hour Plasma Insulin Area Under the Curve [6-hours]
Areas under the curve for insulin concentration will be calculated for hourly samples from a 6-hour lipid tolerance test
6-Hour Plasma Glucose Area Under the Curve [6-hours]
Areas under the curve for glucose concentration will be calculated for hourly samples from a 6-hour lipid tolerance test.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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
Pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Texas at Austin Human Performance Laboratory	Austin	Texas	United States	78712

Sponsors and Collaborators

University of Texas at Austin

Investigators

Principal Investigator: Heath Burton, M.S., University of Texas at Austin
Study Director: Edward F Coyle, Ph.D., University of Texas at Austin

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Edward F. Coyle, Professor, University of Texas at Austin

ClinicalTrials.gov Identifier:

NCT03697382

Other Study ID Numbers:

2018-08-0031

First Posted:

Oct 5, 2018

Last Update Posted:

Sep 30, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Atherosclerosis

Metabolic Syndrome

Study Results

No Results Posted as of Sep 30, 2021