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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06277713
Other study ID # CME2023/069
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 19, 2024
Est. completion date July 1, 2025

Study information

Verified date March 2024
Source Hasselt University
Contact Bert Op 't Eijnde, Prof. dr.
Phone +3211292121
Email bert.opteijnde@uhasselt.be
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this randomised cross-over trial is to learn about the interaction between sedentary behaviour throughout the day and the metabolic effect of an exercise bout on that same day in office workers with an increased risk for chronic disease. The main question this study aims to answer is if the lipid-lowering effects of an exercise bout can be more pronounced by implementing alternations between a seated and a standing working position throughout the day. Participants will be asked to: - Complete three intervention periods for a duration of 2 days at their workplace, - Attend a supervised training session (60min) at the research facility at the end of each intervention period, - Attend three assessment days at the research facility where postprandial metabolism will be evaluated after a standardised meal test.


Description:

The World Health Organisation recently published guidelines with physical activity recommendations that serve to promote healthy lifestyles and thus can help reduce the risk of chronic diseases. In these, they also included for the first time that sedentary behaviour (e.g. sedentary work, driving a car, ...) should be reduced as much as possible since there are clear links between a sedentary lifestyle and negative health effects. However, WHO also indicates that more research is needed to investigate the health effects of interactions between planned physical activity and sedentary behaviour. This is of even greater importance as there are now some studies indicating that the acute effects of an exercise session are greatly reduced when combined with prolonged sitting throughout the day. This new insight has been labelled as sitting-induced exercise resistance. This study aims to investigate whether it is possible to reduce sitting behaviour by moving more and optimally preserve the effects of a training session. This study will evaluate how the combination of sitting behaviour and a training session affects certain health parameters. Indeed, prolonged sitting leads to an increased risk of poor cardiometabolic health and consequently an increased risk of developing conditions such as diabetes and cardiovascular disease. Recent research shows that interrupting prolonged sitting can largely prevent some adverse effects on cardiometabolic health. Furthermore, it also shows that the positive effects of an exercise session are greatly reduced when this workout is scheduled on a day that was otherwise spent mainly sitting. Previous research shows that interrupting sitting behaviour after 20 minutes by short-term (2min) exercise at light intensity would be optimal to improve glucose metabolism. However, this pattern is not very practical to apply in a work environment. For this, installing sit-stand desks could be a solution, as it seems that introducing such sit-stand desks in a work environment could cost-effectively reduce the risk of developing a number of chronic diseases by reducing sitting time. In this study, the effects on postprandial lipemia of reducing prolonged sitting time by introducing sit-stand desks and an exercise bout will be evaluated.


Recruitment information / eligibility

Status Recruiting
Enrollment 24
Est. completion date July 1, 2025
Est. primary completion date October 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 65 Years
Eligibility Inclusion Criteria: - between 30 and 65 years old, - primarily work in an office environment for at least 0.75 full time equivalents, - sedentary (on average >9h of sedentary time per day, assessed objectively), - at an increased risk for disturbances in lipid profile (assessed with fingerstick (Analox®) total cholesterol >200 mg/dL or fingerstick triglycerides >150 mg/dL), - written informed consent to participate in the study. Exclusion Criteria: - medical conditions precluding physical activity (PA) participation, - abusive alcohol intake (>20 units/week), - pregnant or intention to become pregnant, - change in dietary habits or weight loss (>2kg) in the last month before the study, - a diagnosis of cardiometabolic diseases such as diabetes mellitus or cardiovascular diseases.

Study Design


Intervention

Behavioral:
Standing interruptions
A mobile sit-to-stand desk will be installed at the workplace and participants are instructed to alternate their working position every 30 minutes during two working days (8h).
Exercise bout
Participants will perform a continuous aerobic exercise bout for a duration of 60 minutes at a moderate intensity, which is defined as 60% of their maximal oxygen uptake (VO2max).
Sedentary
Participants are instructed to minimise any behaviour that is not sedentary during two working days (8h).

Locations

Country Name City State
Belgium Hasselt University Diepenbeek Limburg

Sponsors (1)

Lead Sponsor Collaborator
Hasselt University

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total and incremental area under the curve of postprandial response in lipid metabolism Lipid levels will be assessed at nine different timepoints (0 minutes, 30 minutes, 60 minutes, 120 minutes, 180 minutes, 210 minutes, 240 minutes, 300 minutes and 360 minutes). Postprandial responses will be defined as the area under the curve (AUC) over the three-hour period after each test meal and the cumulative AUC of the whole time frame. 360 minutes
Secondary Total and incremental area under the curve of glucose and insulin postprandial responses Glucose and insulin levels will be assessed at nine different timepoints (0 minutes, 30 minutes, 60 minutes, 120 minutes, 180 minutes, 210 minutes, 240 minutes, 300 minutes and 360 minutes). Postprandial responses will be defined as the area under the curve (AUC) over the three-hour period after each test meal and the cumulative AUC of the whole time frame. 360 minutes
Secondary Resting metabolic rate Resting metabolic rate will be determined by indirect calorimetry on the morning of each assessment day. 0 minute
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