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Effect of Daily Steps on Fat Metabolism

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ClinicalTrials.gov Identifier: NCT03697382
Recruitment Status : Recruiting
First Posted : October 5, 2018
Last Update Posted : February 18, 2019
Sponsor:
Information provided by (Responsible Party):
Edward F. Coyle, University of Texas at Austin

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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 : September 29, 2018
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : August 31, 2019

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03697382


Contacts
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Contact: Edward F Coyle, Ph.D. (512) 471-8596 coyle@austin.utexas.edu
Contact: Heath Burton, M.S. 8649404103 heath.burton@Utexas.edu

Locations
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United States, Texas
University of Texas at Austin Human Performance Laboratory Recruiting
Austin, Texas, United States, 78712
Contact: Edward F Coyle, Ph.D.    512-471-8596    coyle@austin.utexas.edu   
Contact: Heath M Burton, M.S.    8649404103    heath.burton@utexas.edu   
Sponsors and Collaborators
University of Texas at Austin
Investigators
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Principal Investigator: Heath Burton, M.S. University of Texas at Austin
Study Director: Edward F Coyle, Ph.D. University of Texas at Austin

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Responsible Party: Edward F. Coyle, Professor, University of Texas at Austin
ClinicalTrials.gov Identifier: NCT03697382     History of Changes
Other Study ID Numbers: 2018-08-0031
First Posted: October 5, 2018    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atherosclerosis
Metabolic Syndrome
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases