Obesity, Overweight
Conditions
Keywords
Insulin Resistance, Cognition, Affect, Insulin, Lipids
Brief summary
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
Interventions
BEHAVIORALPhysical activity regime
Information already included in arm descriptions
Sponsors
Unilever R&D
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma insulin levels (measured as area under the curve during an oral glucose tolerance test) | one day after each regime | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate | 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 | — |
| Insulin sensitivity (measured as Matsuda combined insulin sensitivity index during an oral glucose tolerance test) | one day after each regime | To assess the effect of LIPA on insulin sensitivity |
| Plasma C-peptide | one day after each regime | To assess the effect of LIPA on plasma C-peptide |
| Plasma glucose levels | one day after each regime | To assess the effect of LIPA on plasma glucose levels |
| Plasma triglycerides | one day after each regime | To assess the effect of LIPA on plasma triglycerides |
| Plasma total cholesterol | one day after each regime | To assess the effect of LIPA on plasma total cholesterol |
| Plasma non-HDL cholesterol | one day after each regime | To assess the effect of LIPA on plasma non-HDL cholesterol |
| Plasma HDL cholesterol | one day after each regime | To assess the effect of LIPA on plasma HDL cholesterol |
| Plasma LDL cholesterol | one day after each regime | To assess the effect of LIPA on plasma LDL cholesterol |
| Plasma free fatty acids | one day after each regime | To assess the effect of LIPA on plasma free fatty acids |
| Plasma apolipoprotein B | one day after each regime | To assess the effect of LIPA on plasma apolipoprotein B |
| Plasma apolipoprotein A | one day after each regime | To assess the effect of LIPA on plasma apolipoprotein A |
| Mood (measured by the Affect Grid mood scale) | 2 days: last day of each regime and one day after each regime | To assess the effect of LIPA on mood |
| Attention (measured by the Attention Network Task) | one day after each regime before and after the oral glucose tolerance test | To assess the effect of LIPA on attention |
| Blood pressure | one day after each regime | — |
| Memory (measured by the Rey Auditory Verbal Learning Task) | one day after each regime before and after the oral glucose tolerance test | To assess the effect of LIPA on memory |
| Quality of life (measured by the Gill 32-item questionnaire) | last day of each regime | To assess the effect of LIPA on quality of life |
| Sleep (measured by the 10-item Pittsburgh Sleep Quality Index) | last day of each regime | To assess the effect of LIPA on sleep |
| Plasma C-reactive protein | one day after each regime | To assess the effect of LIPA on plasma C-reactive protein |
| Plasma interleukin 1 | one day after each regime | To assess the effect of LIPA on plasma interleukin 1 |
| Plasma interleukin 6 | one day after each regime | To assess the effect of LIPA on plasma interleukin 6 |
| Plasma TNF-alpha | one day after each regime | To assess the effect of LIPA on plasma TNF-alpha |
| Plasma interferon gamma | one day after each regime | To assess the effect of LIPA on plasma interferon gamma |
| Plasma ICAM-1 | one day after each regime | To assess the effect of LIPA on plasma ICAM-1 |
| Plasma VCAM | one day after each regime | To assess the effect of LIPA on plasma VCAM |
| Plasma serum amyloid A (SAA) | one day after each regime | To assess the effect of LIPA on plasma SAA |
| Plasma E-selectine | one day after each regime | To assess the effect of LIPA on plasma E-selectine |
| Plasma von Willebrand factor (vWF) | one day after each regime | To assess the effect of LIPA on plasma vWF |
| Plasma PAI-1 | one day after each regime | To assess the effect of LIPA on plasma PAI-1 |
| Executive Function (measured by the Trail Making Test) | one day after each regime before and after the oral glucose tolerance test | To assess the effect of LIPA on executive function |
Countries
Netherlands
Outcome results
None listed