- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03898206
Effects of Breaking up Prolonged Sitting on Postprandial Cardiometabolic Disease Risk Markers in South Asian Adults
Effects of Breaking up Prolonged Sitting on Postprandial Cardiometabolic Disease Risk Markers in Normal Weight Versus Overweight and Obese South Asian Adults
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Participants will attend a preliminary testing session where height, weight, body fat and waist circumference will be measured. They will be familiarised with a motorised treadmill that will be used during the experimental visit below and will take part in an exercise test to determine a light-intensity walking speed for the experimental visit.
Participants will then attend two experimental visits in a random order:
- Prolonged sitting (SIT): Participants will remain seated for 5 hours and instructed to reduce excessive movement.
- Breaking up sitting with walking breaks (INT-SIT): Participants will rise from the seated position every 30 minutes throughout the experimental period to walk on a motorised treadmill at a light intensity for 5 minutes. After performing walking activity, they will return to the seated position. In addition, blood sample will be taken at the resting position just before each physical activity bout. The activity breaks will be undertaken on 9 occasions, providing a total of 45 min of light-intensity activity.
During each visit, blood pressure will be taken 11 times and blood samples will be taken 10 times. Participants will be given a breakfast and lunch meal to consume.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Bedfordshire
-
Bedford, Bedfordshire, United Kingdom, MK41 9EA
- University of Bedfordshire
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Self-identified South Asian ethnicity.
- Self-report sitting at least 7 hours per day.
- Normal weight, overweight or obese.
Exclusion Criteria:
- Unable to speak and read English.
- Contraindications to performing light-intensity walking.
- Diagnosed cardiovascular disease or diabetes.
Study Plan
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: Prolonged sitting (SIT), then breaking up sitting with walking breaks (INT-SIT)
Firstly, participants will remain seated for 5 h and instructed to reduce excessive movement, only rising from the chair to void. After a washout period of at least 3 days, they then performed the INT-SIT condition. Prolonged sitting (SIT): See SIT arm description Breaking up sitting with walking breaks (INT-SIT): See INT-SIT arm description |
See Prolonged sitting arm description
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|
Experimental: Breaking up sitting with walking breaks (INT-SIT), then prolonged sitting (SIT)
Firstly, participants will rise from the seated position every 30 min throughout the experimental period to walk on a motorised treadmill at a light intensity walking (as determined during the preliminary test) for 5 min. Participants will start walk on a treadmill at 30 min (so physical activity would be at 30-35 min), 60 min (physical activity will be at 60-65 min), 90 min (physical activity will be at 90-95 min), 120 min (physical activity will be 120-125 min), 150 min (physical activity will be at 150-155 min ), and 180 min (physical activity will be at 180-185 min) in the breakfast postprandial period and 30 min (physical activity will be 30-35 min), 60 min (physical activity will be at 60-65 min), and 90 min (physical activity will be at 90-95 min) in the lunch postprandial period. After performing a walking activity, they will return to the seated position. After a washout period of at least 3 days, they then performed the SIT condition. SIT : See SIT arm description |
See Breaking up sitting with walking breaks arm description
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postprandial Glucose
Time Frame: Measured over the 5 hour condition period
|
Incremental area under the curve for each 5 h condition will be calculated for glucose
|
Measured over the 5 hour condition period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postprandial Triglycerides
Time Frame: Measured over the 5 hour condition period
|
Incremental area under the curve for each 5 h condition will be calculated for triglycerides
|
Measured over the 5 hour condition period
|
|
Postprandial Insulin
Time Frame: Measured over the 5 hour condition period
|
Incremental area under the curve for each 5 h condition will be calculated for insulin
|
Measured over the 5 hour condition period
|
|
Metabolic Load Index
Time Frame: Measured over the 5 hour condition period
|
Incremental area under the curve for each 5 h condition will be calculated for the Metabolic Load Index (MLI). The MLI will be calculated using the following equation: MLI (mmol.L-1) = blood glucose (mmol.L-1) + TAG (mmol.L-1). Lower values of MLI are considered better for cardiometabolic health! |
Measured over the 5 hour condition period
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|
Resting Energy Expenditure
Time Frame: Measured for the 5 hour condition period
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Incremental area under the curve for each 5 h condition will be calculated for resting energy expenditure
|
Measured for the 5 hour condition period
|
|
Resting Fat Oxidation
Time Frame: Measured for the 5 hour condition period
|
Incremental area under the curve for each 5 h condition will be calculated for resting fat oxidation
|
Measured for the 5 hour condition period
|
|
Resting Carbohydrate Oxidation
Time Frame: Measured for the 5 hour condition period
|
Incremental area under the curve for each 5 h condition will be calculated for resting carbohydrate oxidation
|
Measured for the 5 hour condition period
|
|
Mean Arterial Pressure
Time Frame: Measured over the 5 hour condition period
|
Mean Arterial Pressure (MAP) over the 5 h conditions. The following formula will be used to calculate MAP, where P is blood pressure (systolic or diastolic): MAP = PDiastolic + 1/3 (PSystolic - PDiastolic). |
Measured over the 5 hour condition period
|
|
Heart Rate
Time Frame: Measured over the 5 hour condition period
|
Mean heart rate over the 5 h conditions
|
Measured over the 5 hour condition period
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019ISPAR003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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