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

Maastricht University Medical Center24 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Overweight

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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)

Time frame: one day after each regime

Secondary Outcomes

Insulin sensitivity (measured as Matsuda combined insulin sensitivity index during an oral glucose tolerance test)

To assess the effect of LIPA on insulin sensitivity

Time frame: one day after each regime

Plasma C-peptide

To assess the effect of LIPA on plasma C-peptide

Time frame: one day after each regime

Plasma glucose levels

To assess the effect of LIPA on plasma glucose levels

Time frame: one day after each regime

Plasma triglycerides

To assess the effect of LIPA on plasma triglycerides

Time frame: one day after each regime

Plasma total cholesterol

To assess the effect of LIPA on plasma total cholesterol

Time frame: one day after each regime

Plasma non-HDL cholesterol

To assess the effect of LIPA on plasma non-HDL cholesterol

Time frame: one day after each regime

Plasma HDL cholesterol

To assess the effect of LIPA on plasma HDL cholesterol

Time frame: one day after each regime

Plasma LDL cholesterol

To assess the effect of LIPA on plasma LDL cholesterol

Time frame: one day after each regime

Plasma free fatty acids

To assess the effect of LIPA on plasma free fatty acids

Time frame: one day after each regime

Plasma apolipoprotein B

To assess the effect of LIPA on plasma apolipoprotein B

Time frame: one day after each regime

Plasma apolipoprotein A

To assess the effect of LIPA on plasma apolipoprotein A

Time frame: one day after each regime

Mood (measured by the Affect Grid mood scale)

To assess the effect of LIPA on mood

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: last day of each regime

Sleep (measured by the 10-item Pittsburgh Sleep Quality Index)

To assess the effect of LIPA on sleep

Time frame: last day of each regime

Plasma C-reactive protein

To assess the effect of LIPA on plasma C-reactive protein

Time frame: one day after each regime

Plasma interleukin 1

To assess the effect of LIPA on plasma interleukin 1

Time frame: one day after each regime

Plasma interleukin 6

To assess the effect of LIPA on plasma interleukin 6

Time frame: one day after each regime

Plasma TNF-alpha

To assess the effect of LIPA on plasma TNF-alpha

Time frame: one day after each regime

Plasma interferon gamma

To assess the effect of LIPA on plasma interferon gamma

Time frame: one day after each regime

Plasma ICAM-1

To assess the effect of LIPA on plasma ICAM-1

Time frame: one day after each regime

Plasma VCAM

To assess the effect of LIPA on plasma VCAM

Time frame: one day after each regime

Plasma serum amyloid A (SAA)

To assess the effect of LIPA on plasma SAA

Time frame: one day after each regime

Plasma E-selectine

To assess the effect of LIPA on plasma E-selectine

Time frame: one day after each regime

Plasma von Willebrand factor (vWF)

To assess the effect of LIPA on plasma vWF

Time frame: one day after each regime

Plasma PAI-1

To assess the effect of LIPA on plasma PAI-1

Time frame: 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

Time frame: one day after each regime

Blood pressure

Time frame: one day after each regime

Heart rate

Time frame: one day after each regime

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes