- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02258438
Effect of Breaking up Prolonged Sitting on Metabolic Flexibility
April 29, 2021 updated by: University of Colorado, Denver
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.
Study Overview
Status
Completed
Conditions
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- University of Colorado Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Uninterrupted sitting
Patient will refrain from any structured activity and reduce any daily life activity.
The patient will spend 24 hours in the calorimeter room.
During the 24 hours the patient will remain sedentary for the 24 hours but will be able to watch TV, computer work or read.
|
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.
|
Experimental: Sitting + 1 bout of activity
The patient will be asked to perform the 45 minutes of moderate-exercise intervention in the morning once per day for two days in their daily life.
This bout of exercise will be supervised by study staff on one of the treadmills On day 3 the patient will report at the Clinical and Translational Research Center (CTRC) of the University Hospital of Colorado and will spend 24hr in the room calorimeter.
During the day, you will be asked to sit quietly in a chair, except to rise from the chair to void, and to perform one bout of 45-min moderate-intensity walking on a treadmill.
|
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.
|
Experimental: Sitting + microbursts of activity
The patient will be asked to refrain from any structured exercise running, swimming, lifting weights, yoga, dancing, etc.) for two days but to walk for the 5 minute intervention each hour between 1000 and 1800.
On day 3, The patient will report at the CTRC of the University Hospital of Colorado and will spend 24hr in the room calorimeter.
During the day, the patient will be asked to rise from the seated position every hour for 9 hours from 1000 to 1800 to complete 5 min moderate-intensity walking on a treadmill, which represents a total of 45 min.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total substrate oxidation
Time Frame: 1 day
|
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
|
Postprandial plasma insulin and glucose response
Time Frame: 1 day
|
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
|
Dietary fat oxidation
Time Frame: 1 day
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 8, 2014
Primary Completion (Actual)
September 1, 2017
Study Completion (Actual)
September 1, 2017
Study Registration Dates
First Submitted
October 2, 2014
First Submitted That Met QC Criteria
October 6, 2014
First Posted (Estimate)
October 7, 2014
Study Record Updates
Last Update Posted (Actual)
April 30, 2021
Last Update Submitted That Met QC Criteria
April 29, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 14-0429
- UL1TR001082 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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