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Effect of Daily Steps on Fat Metabolism

Primary Purpose

Atherosclerosis, Metabolic Syndrome

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Very Low Steps

Low Steps

Moderate Steps

About this trial

This is an interventional prevention trial for Atherosclerosis

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

University of Texas at Austin Human Performance Laboratory

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Very Low Steps

Low Steps

Moderate Steps

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

6-Hour Plasma Insulin Area Under the Curve

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

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

Full Information

NCT ID

NCT03697382

First Posted

September 25, 2018

Last Updated

September 29, 2021

Sponsor

University of Texas at Austin

1. Study Identification

Unique Protocol Identification Number

NCT03697382

Brief Title

Effect of Daily Steps on Fat Metabolism

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

September 29, 2018 (Actual)

Primary Completion Date

February 15, 2020 (Actual)

Study Completion Date

May 31, 2020 (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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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 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)

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Very Low Steps

Arm Type

Experimental

Arm Description

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.

Arm Title

Low Steps

Arm Type

Experimental

Arm Description

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.

Arm Title

Moderate Steps

Arm Type

Experimental

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Very Low Steps

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 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.

Intervention Type

Behavioral

Intervention Name(s)

Low Steps

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 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.

Intervention Type

Behavioral

Intervention Name(s)

Moderate Steps

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 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.

Primary Outcome Measure Information:

Title

6-Hour Plasma Triglyceride Area Under the Curve

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

6-Hour Plasma Insulin Area Under the Curve

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

6-Hour Plasma Glucose Area Under the Curve

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

Eligibility 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 Pregnancy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Heath Burton, M.S.

Organizational Affiliation

University of Texas at Austin

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Edward F Coyle, Ph.D.

Organizational Affiliation

University of Texas at Austin

Official's Role

Study Director

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

Citations:

PubMed Identifier

33105387

Citation

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.

Results Reference

derived

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Effect of Daily Steps on Fat Metabolism

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