Metabolic HealthNCT05306678
Breaking Sitting and Metabolic Health in Sedentary Overweight and Obese Adults
A study testing Prolonged sitting and Breaking sitting in people with Metabolic Health and Gut Hormones, run by National Taiwan Normal University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Health, Gut Hormones, Energy Balance
- What is being tested?
- Prolonged sitting and Breaking sitting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteTaiwan
- Study dates
- 29 Dec 2020to 1 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Effects of Breaking Prolonged Sitting on Postprandial Glycaemic Response, Incretin Hormones Secretion and Eating Behaviour in Overweight and Obese Adults
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.
Read the 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.
- Conditions
- Metabolic Health, Gut Hormones, Energy Balance
- Being tested
- Prolonged sitting, Breaking sitting
- Keywords
- GLP-1, PYY, Breaking sitting, Energy balance, Postprandial glycaemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged sittingBehavioural
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.
Breaking sittingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Prolonged sitting | Experimental | Prolonged sitting Receives: Behavioral: Prolonged sitting |
| Breaking sitting | Experimental | Breaking prolonged sitting Receives: Behavioral: Breaking sitting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut hormones responses
Changes in blood gut hormones responses (e.g., GLP-1, PYY and GIP concentrations measured in pmol/L) between trials
Measured: 320 minutes
Secondary outcomes (7)
Visual analogue scale (VAS)
Changes in VAS from 0-100 mm (e.g., appetite and mood, etc.) between trials
Measured: 320 minutes
Energy intake
Changes in energy intake (e.g, using a food diary to record) after leaving the laboratory until midnight
Measured: 600 minutes after leaving the labalotory
Physical activity level
Changes in physical activity level (e.g., using an accelerometer to record) after leaving the laboratory until midnight
Measured: 600 minutes after leaving the labalotory
Lipid profile
Changes in blood lipid profile (e.g., TAG and cholesterol, etc.) between trials
Measured: 320 minutes
Blood pressure
Changes in blood pressure (e.g., diastolic and systolic blood pressure) between trials
Measured: 320 minutes
Computerized cognitive testing
Changes in cognitive function (e.g., accuracy and reaction time) between trials
Measured: 320 minutes
Incremental area under curve (iAUC) for metabolic health
Changes in incremental area under curve (iAUC) for insulin and glucose between trials
Measured: 320 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start29 Dec 2020
- Primary completion1 Mar 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yung-Chih Chen, National Taiwan Normal University
- Investigators
- Chen, PhD, Principal investigator, National Taiwan Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05306678
- Sponsor's protocol ID
- 201912HM107-
- Status last verified
- Apr 2024
- First submitted
- 15 Mar 2022
- Last updated
- 1 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Breaking Prolonged Sitting on Postprandial Glycaemic Response, Incretin Hormones Secretion and Eating Behaviour in Overweight and Obese Adults
- ClinicalTrials.gov ID
- NCT05306678
- Acronym / sponsor ID
- 201912HM107-
- Conditions
- Metabolic Health, Gut Hormones, Energy Balance
- Keywords
- GLP-1, PYY, Breaking sitting, Energy balance, Postprandial glycaemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- National Taiwan Normal UniversityUniversity, hospital or other
- Study start
- 29 Dec 2020 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 1 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prolonged sitting | Experimental | Behavioral: Prolonged sittingProlonged sitting |
| Breaking sitting | Experimental | Behavioral: Breaking sittingBreaking prolonged sitting |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prolonged sittingAfter 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. | Behavioural | Prolonged sitting |
| Breaking sittingAfter 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. | Behavioural | Breaking sitting |
Primary outcome
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
7 secondary outcomes
Visual analogue scale (VAS)
Time frame: 320 minutes
Energy intake
Time frame: 600 minutes after leaving the labalotory
Physical activity level
Time frame: 600 minutes after leaving the labalotory
Lipid profile
Time frame: 320 minutes
Blood pressure
Time frame: 320 minutes
Computerized cognitive testing
Time frame: 320 minutes
Incremental area under curve (iAUC) for metabolic health
Time frame: 320 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chen, PhD principal investigator
National Taiwan Normal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolonged sitting and Breaking sitting in people with Metabolic Health and Gut Hormones, run by National Taiwan Normal University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut hormones responses (time frame: 320 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2024.