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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02258438
Other study ID # 14-0429
Secondary ID UL1TR001082
Status Completed
Phase N/A
First received
Last updated
Start date October 8, 2014
Est. completion date September 2017

Study information

Verified date April 2021
Source University of Colorado, Denver
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigators propose in this project to determine the effect of 3 days of frequent interruption of prolonged sitting on metabolic health in healthy overweight sedentary adults (n=24), as compared to 3 days including a single long bout of isocaloric exercise or a control condition where subjects do not exercise but are subjected to prolonged sitting. The investigators believe that this proposed project will provide an initial evidence base for the health benefits of breaking up prolonged sitting with short bursts of moderate-intensity activity, like walking.


Description:

Although public-health recommendations to engage in moderate-to-vigorous physical activity (at least 30min, 5 days / week) have been widely promulgated by the government, most people are physically inactive. Sedentary behaviors, like time spent sitting, are associated with serious implications on metabolic health, indicating that even in individuals who regularly exercise a reduction in time spent sitting can confer health benefits. Encouraging recent evidence shows that walking breaks throughout the day are an effective strategy to offset the deleterious effects of prolonged uninterrupted sitting. Further data however are needed to better understand the effect of these microbursts of activity along the day. The investigators propose in this project to determine the effect of 3 days of frequent interruption of prolonged sitting on metabolic health in healthy overweight sedentary adults (n=24), as compared to 3 days including a single long bout of isocaloric exercise or a control condition where subjects do not exercise but are subjected to prolonged sitting. Plasma glucose, insulin, triglycerides and free fatty acids concentrations and the use of substrate (glucose, fat or protein) to provide energy to the body in response to meals consumption will be measured on day 3 of each of these three conditions. The investigators will furthermore assess the ability of the participants to perform the interventions on physical activity at the end of each day over the three days of intervention (2 days in free-living conditions and one day in a controlled environment). The investigators believe that this proposed project will provide an initial evidence base for the health benefits of breaking up prolonged sitting with short bursts of moderate-intensity activity, like walking. This innovative strategy may be more effective at combating the adverse effects of sedentary behaviors than more traditional approaches like structured exercise.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date September 2017
Est. primary completion date September 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 45 Years
Eligibility Inclusion Criteria: - overweight but weight stable (less than +/- 3kg over previous 6 months) male and female adults (n=24) will be recruited. - age between 19-45 years old, - a BMI of 27-33 kg/m2, - inactive (= 1.5hr/wk of moderate-to-vigorous activity), - sedentary (office employees who are spending more than 6hrs/day in sitting position) and - English-speaking. Exclusion Criteria: - any history of renal, cardiovascular or hepatic diseases, - type 1 or 2 diabetes, - cancer, - pregnancy, - smoking, - consumption of drugs or alcohol (>40g/d), - any medications known to interfere with lipid or energy metabolism, - known physical activity contraindications, or major illness/physical problems (acute or chronic) that may limit their ability to perform the walking activities and - menopause (defined as no menses in the prior 6 months). The use of birth pill control will be accepted. Women are asked to avoid pregnancy until completion of Condition C.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Uninterrupted sitting
Subjects will be asked to refrain for two days from any structured activity and to reduce any daily life activity (walking, taking the stairs, biking, etc.) in their daily life. On day 3, subjects will remain seated all day in the room calorimeter, except to rise from the chair to void.
Sitting + 1 bout of activity
Subjects will be asked to perform 45 minutes of moderate-exercise in the morning once per day for two days in their daily life. On day 3 they will remain seated all day in the room calorimeter, except to rise from the chair to void, and to perform one bout of 45-min moderate-intensity (defined below) walking on a treadmill at 1000.
Sitting + microbursts of activity
Subjects will be asked to refrain from any structured exercise for two days but to walk for 5 minutes each hour between 1000 and 1800 in daily life. On day 3, subjects will rise from the seated position every hour for 9 hours from 1000 to 1800 to complete 5min moderate-intensity (defined below) walking on a treadmill, which represents a total of 45min.

Locations

Country Name City State
United States University of Colorado Hospital Aurora Colorado

Sponsors (1)

Lead Sponsor Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total substrate oxidation Total fat oxidation during the test day will be determined using whole-room indirect calorimetry. O2 consumption and CO2 production will be determined from the flow rates and differences in gas concentrations between air entering and air exiting the calorimeter as previously described 1 day
Primary Postprandial plasma insulin and glucose response Plasma glucose and insulin will be measured in fasting conditions and hourly during 12hrs following a standard meal consumption. The area under the curve will be calculated for both plasma glucose and insulin. This area will represent the postprandial response to a meal for both insulin and glucose. 1 day
Primary Dietary fat oxidation Subjects will collect their own hourly breath sampling for 13CO2 by blowing through a straw into two 15ml Vacutainer after the investigators will have shown them the procedure. Breath CO2 will be sampled directly from the Vacutainer with a syringe, and 13CO2 /12CO2 measured with Isotopic Ratio Mass Spectrometer (IRMS). 1 day
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