SIT LESS 3: The Effect of Low Intensity Physical Activity on Insulin Sensitivity, Mood and Cognitive Performance

Study Overview
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Brief Summary
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Background of the study: A sedentary lifestyle and obesity are well known risk factors of type 2 diabetes. The major focus of current guidelines for type 2 diabetes prevention is on energy balance. Physical activity guidelines recommend at least 30 minutes/day of moderate to vigorous physical activity (MVPA). However, no advice is given how the other 23.5 hours of the day should be spent. Several recent epidemiologic studies suggest that excessive sitting, independent of moderate to vigorous physical activity, has detrimental health effects. Another possibility to sit less is by increasing low intensity physical activities as slowly walking and standing. A recent published study of Duvivier and colleagues suggests that sitting less and replacing it by slowly walking and standing has a better effect on insulin action and cardiovascular risk factors than the combination of one hour MVPA per day and sitting the rest of the day in healthy subjects (Duvivier et al. PLOS ONE 2013). Until now this research is not performed in subjects with overweight/obesity. Objective of the study: To assess the effect of low intensity physical activity on plasma insulin levels, cognition and mood in subjects with overweight/obesity Study population: 21 subjects between 40-80 years old with overweight/obesity Intervention: 2 activity regimes of 4 days: a sitting regime and a sit less regime

Official Title
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SIT LESS 3: The Effect of Low Intensity Physical Activity on Insulin Sensitivity, Mood and Cognitive Performance

Conditions
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Overweight, Obesity

Intervention / Treatment
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* Behavioral: Physical activity regime


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent Men and postmenopausal women: 40-80 years old BMI: 25.0 - 35.0 kg/m2 Maximum 2.5 hours of MVPA per week (during last 3 months) Having a general practitioner Agreeing to be informed about medically relevant personal test-results by a physician Accessible veins on arms as determined by examination at screening Exclusion Criteria: Reported participation in another biomedical trial which may have an effect on insulin sensitivity one month before the pre-study examination or during the study Blood donation in the past three months Reported participation in night shift work 2 weeks prior to pre-study investigation or during the study. Night work is defined as working between midnight and 6.00 AM. Consumption of >14 (women) or > 21 (men) alcoholic units per week Reported dietary habits: medically prescribed diet, slimming diet; Reported weight loss (>2kg) in the last three months prior to the screening; Not being able to execute at least three (out of four) cognition tests in the training session Not being able to execute the sit less try-out day Being an employee of Unilever or the collaborating research departments in Maastricht University Medical Centre Experimental drug use (during the last 3 months) Use of insulin, oral blood glucose lowering medication (metformin and/or SU-derivatives and/or DPP-IV inhibitors), corticosteroids or vitamin K antagonists in the last 3 months Fasting plasma glucose level > 6.9 mmol/L Medical conditions which make participation in the study not responsible which will be decided by a medical doctor during screening Other clinically relevant abnormalities in clinical chemistry at screening (to be judged by a medical doctor) Mental or physical disability which interferes with physical activity

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sitting regime<br>The subjects will follow the sitting regime during four days. Each day: 14 hours sitting, 1 hour walking and 1 hour standing and 8 hours sleeping. | Behavioral: Physical activity regime<br>* Information already included in arm descriptions<br>|
| Experimental: Sit Less regime<br>Subjects will follow the sit less regime during four days. Each day will consist of 9 hours sitting, 4 hours walking, 3 hours standing and 8 hours sleeping. The walking and standing will be done in a minimum of eight bouts with a time interval of >1 hour. The subjects will be instructed to walk on a slow pace, i.e. 2-3 km/h, which is comparable to walking during shopping, walking to the office etc. | Behavioral: Physical activity regime<br>* Information already included in arm descriptions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma insulin levels (measured as area under the curve during an oral glucose tolerance test) | To assess the effect of low intensity physical activity (LIPA) on plasma insulin levels (as measured as area under the curve during an oral glucose tolerance test) | one day after each regime | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin sensitivity (measured as Matsuda combined insulin sensitivity index during an oral glucose tolerance test) | To assess the effect of LIPA on insulin sensitivity | one day after each regime | 
| Plasma C-peptide | To assess the effect of LIPA on plasma C-peptide | one day after each regime | 
| Plasma glucose levels | To assess the effect of LIPA on plasma glucose levels | one day after each regime | 
| Plasma triglycerides | To assess the effect of LIPA on plasma triglycerides | one day after each regime | 
| Plasma total cholesterol | To assess the effect of LIPA on plasma total cholesterol | one day after each regime | 
| Plasma non-HDL cholesterol | To assess the effect of LIPA on plasma non-HDL cholesterol | one day after each regime | 
| Plasma HDL cholesterol | To assess the effect of LIPA on plasma HDL cholesterol | one day after each regime | 
| Plasma LDL cholesterol | To assess the effect of LIPA on plasma LDL cholesterol | one day after each regime | 
| Plasma free fatty acids | To assess the effect of LIPA on plasma free fatty acids | one day after each regime | 
| Plasma apolipoprotein B | To assess the effect of LIPA on plasma apolipoprotein B | one day after each regime | 
| Plasma apolipoprotein A | To assess the effect of LIPA on plasma apolipoprotein A | one day after each regime | 
| Mood (measured by the Affect Grid mood scale) | To assess the effect of LIPA on mood | 2 days: last day of each regime and one day after each regime | 
| Attention (measured by the Attention Network Task) | To assess the effect of LIPA on attention | one day after each regime before and after the oral glucose tolerance test | 
| Executive Function (measured by the Trail Making Test) | To assess the effect of LIPA on executive function | one day after each regime before and after the oral glucose tolerance test | 
| Memory (measured by the Rey Auditory Verbal Learning Task) | To assess the effect of LIPA on memory | one day after each regime before and after the oral glucose tolerance test | 
| Quality of life (measured by the Gill 32-item questionnaire) | To assess the effect of LIPA on quality of life | last day of each regime | 
| Sleep (measured by the 10-item Pittsburgh Sleep Quality Index) | To assess the effect of LIPA on sleep | last day of each regime | 
| Plasma C-reactive protein | To assess the effect of LIPA on plasma C-reactive protein | one day after each regime | 
| Plasma interleukin 1 | To assess the effect of LIPA on plasma interleukin 1 | one day after each regime | 
| Plasma interleukin 6 | To assess the effect of LIPA on plasma interleukin 6 | one day after each regime | 
| Plasma TNF-alpha | To assess the effect of LIPA on plasma TNF-alpha | one day after each regime | 
| Plasma interferon gamma | To assess the effect of LIPA on plasma interferon gamma | one day after each regime | 
| Plasma ICAM-1 | To assess the effect of LIPA on plasma ICAM-1 | one day after each regime | 
| Plasma VCAM | To assess the effect of LIPA on plasma VCAM | one day after each regime | 
| Plasma serum amyloid A (SAA) | To assess the effect of LIPA on plasma SAA | one day after each regime | 
| Plasma E-selectine | To assess the effect of LIPA on plasma E-selectine | one day after each regime | 
| Plasma von Willebrand factor (vWF) | To assess the effect of LIPA on plasma vWF | one day after each regime | 
| Plasma PAI-1 | To assess the effect of LIPA on plasma PAI-1 | one day after each regime | 
| To explore the association between plasma glucose, plasma insulin, insulin sensitivity and mood, cognitive performance, quality of life and sleep |  | one day after each regime | 
| Blood pressure |  | one day after each regime | 
| Heart rate |  | one day after each regime | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognition, Affect, Insulin, Lipids, Insulin Resistance