- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02215603
Effects of Disrupting Prolonged Sitting With Different Physical Activity Protocols on Metabolic Risk Factors in Sedentary Adults
Great controversy exists with respect to the optimal or the minimum volume, intensity, and frequency of physical activity capable of attenuating the hazards of prolonged sitting on the metabolic profile. Thus, our study aims to comprehensively investigate the effects of disrupting prolonged sitting with different physical activity protocols on metabolic risk factors in sedentary males.
Ten sedentary males will take part in this randomized cross-over trial consisting of four 27-h conditions. All conditions will be identical except for the physical activity: prolonged sitting intervention (SIT) participants will sit continuously for 9 hours; prolonged sitting+interval standing intervention (STAND), participants will stand for 15 min every 30 minutes (total 270 min) during the 9 hours of sitting; prolonged sitting+moderate-intensity exercise bout (MVPA) participants will perform a 30-min moderate-intensity exercise bout on a treadmill (energy-matched to STAND), after which they will sit for the remaining time; and prolonged sitting+moderate-intensity exercise bout +interval standing intervention (MVPA-STAND), participants will perform a 30-min moderate-intensity exercise bout on a treadmill (energy-matched to STAND), after which they will stand for 15 min every 30 minutes (total 240 min) during the remaining 8 hours of sitting. Blood glucose, insulin, lipids and cytokines will be determined.
The investigators expect that disrupting prolonged sitting with intermittent standing and a moderate-exercise bout will positively affect the metabolic profile of the participants. Furthermore, we will investigate if combined, these strategies will have an additive effect.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Fabiana Benatti
- Phone Number: +45 35450898
- Email: fabiana.braga.benatti@regionh.dk
Study Locations
-
-
-
Copenhagen, Denmark, 2100
- Recruiting
- Centre of Inflammation and Metabolism
-
Contact:
- Inge Holm
-
Principal Investigator:
- Bente Pedersen, PhD
-
Sub-Investigator:
- Fabiana Benatti, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Males,
- age 25-55 y,
- BMI >18 and <35 kg/m2
Exclusion Criteria:
- Clinically diagnosed diabetes,
- dyslipidaemia,
- hypertension,
- use of glucose- and/or lipid-lowering medication,
- smoking,
- evidence of thyroid, liver, lung, heart or kidney disease,
- non-sedentary occupation and primary means of commuting to work (i.e., cycling) in the last 4 months,
- VO2max levels above the considered average fitness according to age,
- contraindication to increased levels of physical activity.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Prolonged sitting
9 h of prolonged sitting
|
|
Experimental: Prolonged sitting + interval standing bouts
Stand bout for 15-min every 30 minutes during the 9 hours of sitting
|
|
Experimental: Moderate exercise bout + Prolonged sitting
30-min moderate-intensity exercise bout followed by 8 h of sitting
|
|
Experimental: Moderate exercise bout + Prolonged sitting +Standing bouts
30-min moderate-intensity exercise bout and stand bout for 15-min every 30 minutes during the remaining 8 hours of sitting
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area under the curve of glucose and insulin postprandial responses
Time Frame: 27 h
|
Glucose and insulin levels will be assessed 10 min before, and 30, 60, 120 and 180 min after each main meal.
These postprandial responses will be defined as the area under the curve (AUC) assessed over the 3-h period after each main meal (3-h AUC) and the cumulative AUC after all main meals (12-h AUC).
|
27 h
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glucose levels
Time Frame: 27 hours
|
Glucose incursions will measured using the glucose monitoring (CGM) system throughout the 27 hours.
Mean, maximum and minimum glucose values during the 27h will be the outcome measures (mmol/l).
|
27 hours
|
Area under the curve of lipid postprandial responses
Time Frame: 27 h
|
Lipid levels will be assessed 10 min before, and 30, 60, 120 and 180 min after each main meal.
These postprandial responses will be defined as the area under the curve (AUC) assessed over the 3-h period after each main meal (3-h AUC) and the cumulative AUC after all main meals (12-h AUC).
|
27 h
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area under the curve of cytokine postprandial responses
Time Frame: 27 h
|
Cytokine levels (TNF-alpha, IL-6, IL-10, and IL1-ra) will be assessed 10 min before, and 30, 60, 120 and 180 min after each main meal.
These postprandial responses will be defined as the area under the curve (AUC) assessed over the 3-h period after each main meal (3-h AUC) and the cumulative AUC after all main meals (12-h AUC).
|
27 h
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ProlongedSitting
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