Breaking Sitting and Metabolic Health in Sedentary Overweight and Obese Adults
Primary Purpose
Metabolic Health, Gut Hormones, Energy Balance
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Prolonged sitting
Breaking sitting
Sponsored by
About this trial
This is an interventional basic science trial for Metabolic Health focused on measuring GLP-1, PYY, Breaking sitting, Energy balance, Postprandial glycaemia
Eligibility Criteria
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)
Sites / Locations
- National Taiwan Normal UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Prolonged sitting
Breaking sitting
Arm Description
Prolonged sitting
Breaking prolonged sitting
Outcomes
Primary Outcome Measures
Incremental area under curve (iAUC) for metabolic health
Changes in incremental area under curve (iAUC) for insulin and glucose between trials
Secondary Outcome Measures
Gut hormones responses
Changes in blood gut hormones responses (e.g., GLP-1, PYY and GIP, etc.) between trials
Visual analogue scale (VAS)
Changes in VAS from 0-100 mm (e.g., appetite and mood, etc.) between trials
Energy intake
Changes in energy intake (e.g, using a food diary to record) after leaving the laboratory until midnight
Physical activity level
Changes in physical activity level (e.g., using an accelerometer to record) after leaving the laboratory until midnight
Lipid profile
Changes in blood lipid profile (e.g., TAG and cholesterol, etc.) between trials
Blood pressure
Changes in blood pressure (e.g., diastolic and systolic blood pressure) between trials
Computerized cognitive testing
Changes in cognitive function (e.g., accuracy and reaction time) between trials
Full Information
NCT ID
NCT05306678
First Posted
March 15, 2022
Last Updated
March 21, 2023
Sponsor
National Taiwan Normal University
1. Study Identification
Unique Protocol Identification Number
NCT05306678
Brief Title
Breaking Sitting and Metabolic Health in Sedentary Overweight and Obese Adults
Official Title
Acute Effects of Breaking Prolonged Sitting on Postprandial Glycaemic Response, Incretin Hormones Secretion and Eating Behaviour in Overweight and Obese Adults
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 29, 2020 (Actual)
Primary Completion Date
April 1, 2023 (Anticipated)
Study Completion Date
April 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Taiwan Normal University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this project is to investigate the effects of breaking up prolonged sitting on postprandial metabolic responses, gut hormones secretion and energy balance in sedentary overweight and obese adults.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Health, Gut Hormones, Energy Balance
Keywords
GLP-1, PYY, Breaking sitting, Energy balance, Postprandial glycaemia
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Prolonged sitting
Arm Type
Experimental
Arm Description
Prolonged sitting
Arm Title
Breaking sitting
Arm Type
Experimental
Arm Description
Breaking prolonged sitting
Intervention Type
Behavioral
Intervention Name(s)
Prolonged sitting
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Breaking sitting
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incremental area under curve (iAUC) for metabolic health
Description
Changes in incremental area under curve (iAUC) for insulin and glucose between trials
Time Frame
320 minutes
Secondary Outcome Measure Information:
Title
Gut hormones responses
Description
Changes in blood gut hormones responses (e.g., GLP-1, PYY and GIP, etc.) between trials
Time Frame
320 minutes
Title
Visual analogue scale (VAS)
Description
Changes in VAS from 0-100 mm (e.g., appetite and mood, etc.) between trials
Time Frame
320 minutes
Title
Energy intake
Description
Changes in energy intake (e.g, using a food diary to record) after leaving the laboratory until midnight
Time Frame
600 minutes after leaving the labalotory
Title
Physical activity level
Description
Changes in physical activity level (e.g., using an accelerometer to record) after leaving the laboratory until midnight
Time Frame
600 minutes after leaving the labalotory
Title
Lipid profile
Description
Changes in blood lipid profile (e.g., TAG and cholesterol, etc.) between trials
Time Frame
320 minutes
Title
Blood pressure
Description
Changes in blood pressure (e.g., diastolic and systolic blood pressure) between trials
Time Frame
320 minutes
Title
Computerized cognitive testing
Description
Changes in cognitive function (e.g., accuracy and reaction time) between trials
Time Frame
320 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yung-Chih Chen, PhD
Phone
+886277496979
Email
yc.chen@ntnu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chen, PhD
Organizational Affiliation
National Taiwan Normal University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan Normal University
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yung-Chih Chen, PhD
Email
yc.chen@ntnu.edu.tw
12. IPD Sharing Statement
Plan to Share IPD
No
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Breaking Sitting and Metabolic Health in Sedentary Overweight and Obese Adults
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