- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05306678
Breaking Sitting and Metabolic Health in Sedentary Overweight and Obese Adults
Acute Effects of Breaking Prolonged Sitting on Postprandial Glycaemic Response, Incretin Hormones Secretion and Eating Behaviour in Overweight and Obese Adults
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Two trials are included in this project - Prolonged sitting and Breaking sitting.
In the Prolonged sitting trial, after consuming breakfast, participants sat on a chair for 180 min. After 180 min, lunch was provided. After finishing lunch, participants sat on a chair for another 120 min. In the Breaking sitting trial, after consuming breakfast, participants walked 2 min on a treadmill every 20 minutes for the following 180 min. For the remainder of the time participants sat on the chair. After 180 min, lunch was provided. After finishing lunch, participants continued 2 min of walking every 20 min for the following 120 min. Blood samples were collected in a regular pattern throughout the trials. Energy balance (e.g., energy intake and spontaneous physical activity) was assessed using food diary and an accelerometer until midnight in the trial days once participants left laboratory.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Taipei, Taiwan
- National Taiwan Normal University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Physical inactive males and females
- Aged between 20 and 45 years
- Overweight and obese healthy adults (waist circumference greater than 90 cm for males and 80 cm for females)
- Weight stable for more than 3 months (no change in weight +/- 3%)
- Non-smoker
- Able to walk comfortably on a treadmill
Exclusion Criteria:
- Personal history of/existing diabetes, cardiovascular disease, metabolic disease or dyslipidaemia
- Waist circumference < 90 cm for male and < 80 cm for female
- Taking medications that may influence lipid or carbohydrate metabolism or immune system function
- Unable to take part in exercise for any reason (e.g., injury or disability) or a positive response to any questions on the Physical Activity Readiness questionnaire (PAR-Q)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Prolonged sitting
|
After consuming breakfast, participants sat on a chair for 180 min.
After 180 min, lunch was provided.
After finishing lunch, participants sat on a chair for another 120 min.
|
|
Experimental: Breaking sitting
Breaking prolonged sitting
|
After consuming breakfast, participants walked 2 min on a treadmill every 20 minutes for the following 180 min.
For the remainder of the time participants sat on the chair.
After 180 min, lunch was provided.
After finishing lunch, participants continued 2 min of walking every 20 min for the following 120 min.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gut hormones responses
Time Frame: 320 minutes
|
Changes in blood gut hormones responses (e.g., GLP-1, PYY and GIP concentrations measured in pmol/L) between trials
|
320 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incremental area under curve (iAUC) for metabolic health
Time Frame: 320 minutes
|
Changes in incremental area under curve (iAUC) for insulin and glucose between trials
|
320 minutes
|
|
Visual analogue scale (VAS)
Time Frame: 320 minutes
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Changes in VAS from 0-100 mm (e.g., appetite and mood, etc.) between trials
|
320 minutes
|
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Energy intake
Time Frame: 600 minutes after leaving the labalotory
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Changes in energy intake (e.g, using a food diary to record) after leaving the laboratory until midnight
|
600 minutes after leaving the labalotory
|
|
Physical activity level
Time Frame: 600 minutes after leaving the labalotory
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Changes in physical activity level (e.g., using an accelerometer to record) after leaving the laboratory until midnight
|
600 minutes after leaving the labalotory
|
|
Lipid profile
Time Frame: 320 minutes
|
Changes in blood lipid profile (e.g., TAG and cholesterol, etc.) between trials
|
320 minutes
|
|
Blood pressure
Time Frame: 320 minutes
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Changes in blood pressure (e.g., diastolic and systolic blood pressure) between trials
|
320 minutes
|
|
Computerized cognitive testing
Time Frame: 320 minutes
|
Changes in cognitive function (e.g., accuracy and reaction time) between trials
|
320 minutes
|
Collaborators and Investigators
Investigators
- Principal Investigator: Chen, PhD, National Taiwan Normal University
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
- 201912HM107-
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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