Clinical trial NCT02394249: SIT LESS 3: The Effect of Low Intensity Physical Activity on Insulin Sensitivity, Mood and Cognitive Performance
Official title: SIT LESS 3: The Effect of Low Intensity Physical Activity on Insulin Sensitivity, Mood and Cognitive Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Keywords: Insulin Resistance
Cognition
Affect
Insulin
Lipids
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Unilever R&D
First posted: 2015-03-20
Enrollment: 24
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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


Eligibility criteria: 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

Primary outcomes:
measure: Plasma insulin levels (measured as area under the curve during an oral glucose tolerance test)
timeFrame: one day after each regime
Secondary outcomes:
measure: Insulin sensitivity (measured as Matsuda combined insulin sensitivity index during an oral glucose tolerance test)
timeFrame: one day after each regime
measure: Plasma C-peptide
timeFrame: one day after each regime
measure: Plasma glucose levels
timeFrame: one day after each regime
measure: Plasma triglycerides
timeFrame: one day after each regime
measure: Plasma total cholesterol
timeFrame: one day after each regime
measure: Plasma non-HDL cholesterol
timeFrame: one day after each regime
measure: Plasma HDL cholesterol
timeFrame: one day after each regime
measure: Plasma LDL cholesterol
timeFrame: one day after each regime
measure: Plasma free fatty acids
timeFrame: one day after each regime
measure: Plasma apolipoprotein B
timeFrame: one day after each regime
measure: Plasma apolipoprotein A
timeFrame: one day after each regime
measure: Mood (measured by the Affect Grid mood scale)
timeFrame: 2 days: last day of each regime and one day after each regime
measure: Attention (measured by the Attention Network Task)
timeFrame: one day after each regime before and after the oral glucose tolerance test
measure: Executive Function (measured by the Trail Making Test)
timeFrame: one day after each regime before and after the oral glucose tolerance test
measure: Memory (measured by the Rey Auditory Verbal Learning Task)
timeFrame: one day after each regime before and after the oral glucose tolerance test
measure: Quality of life (measured by the Gill 32-item questionnaire)
timeFrame: last day of each regime
measure: Sleep (measured by the 10-item Pittsburgh Sleep Quality Index)
timeFrame: last day of each regime
measure: Plasma C-reactive protein
timeFrame: one day after each regime
measure: Plasma interleukin 1
timeFrame: one day after each regime
measure: Plasma interleukin 6
timeFrame: one day after each regime
measure: Plasma TNF-alpha
timeFrame: one day after each regime
measure: Plasma interferon gamma
timeFrame: one day after each regime
measure: Plasma ICAM-1
timeFrame: one day after each regime
measure: Plasma VCAM
timeFrame: one day after each regime
measure: Plasma serum amyloid A (SAA)
timeFrame: one day after each regime
measure: Plasma E-selectine
timeFrame: one day after each regime
measure: Plasma von Willebrand factor (vWF)
timeFrame: one day after each regime
measure: Plasma PAI-1
timeFrame: one day after each regime
measure: To explore the association between plasma glucose, plasma insulin, insulin sensitivity and mood, cognitive performance, quality of life and sleep
timeFrame: one day after each regime
measure: Blood pressure
timeFrame: one day after each regime
measure: Heart rate
timeFrame: one day after each regime
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Human Movement Science, Maastricht University
Study officials:
affiliation: Maastricht University Hospital
name: Hans H Savelberg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Duvivier BM, Schaper NC, Bremers MA, van Crombrugge G, Menheere PP, Kars M, Savelberg HH. Minimal intensity physical activity (standing and walking) of longer duration improves insulin action and plasma lipids more than shorter periods of moderate to vigorous exercise (cycling) in sedentary subjects when energy expenditure is comparable. PLoS One. 2013;8(2):e55542. doi: 10.1371/journal.pone.0055542. Epub 2013 Feb 13.