Effect of Daily Steps on Fat Metabolism

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

September 25, 2018

First Posted Date ^ICMJE

October 5, 2018

Last Update Posted Date

October 5, 2018

Actual Study Start Date ^ICMJE

September 29, 2018

Estimated Primary Completion Date

May 31, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

6-Hour Plasma Triglyceride Area Under the Curve[ Time Frame: 6-hours ]

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

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

Effect of Daily Steps on Fat Metabolism

Official Title ^ICMJE

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

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.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

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.
Masking: Interventional
Masking Description:
Primary Purpose: Prevention

Condition ^ICMJE

Intervention ^ICMJE

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.
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.
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.

Study Arms

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.
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.
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.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

August 31, 2019

Estimated Primary Completion Date

May 31, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

University of Texas at Austin

Collaborators ^ICMJE

Investigators ^ICMJE

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

PRS Account

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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