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Completed

NCT Number: NCT02394249

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

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

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Human Movement Science, Maastricht University

Maastricht, 6200MD, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical activity regime

Behavioral

Information already included in arm descriptions

Primary outcomes

  1. Plasma insulin levels (measured as area under the curve during an oral glucose tolerance test)

    Time frame: 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 outcomes

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

    Time frame: one day after each regime

    To assess the effect of LIPA on insulin sensitivity

  2. Plasma C-peptide

    Time frame: one day after each regime

    To assess the effect of LIPA on plasma C-peptide

  3. Plasma glucose levels

    Time frame: one day after each regime

    To assess the effect of LIPA on plasma glucose levels

  4. Plasma triglycerides

    Time frame: one day after each regime

    To assess the effect of LIPA on plasma triglycerides

  5. Plasma total cholesterol

    Time frame: one day after each regime

    To assess the effect of LIPA on plasma total cholesterol

  6. Plasma non-HDL cholesterol

    Time frame: one day after each regime

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

  7. Plasma HDL cholesterol

    Time frame: one day after each regime

    To assess the effect of LIPA on plasma HDL cholesterol

  8. Plasma LDL cholesterol

    Time frame: one day after each regime

    To assess the effect of LIPA on plasma LDL cholesterol

  9. Plasma free fatty acids

    Time frame: one day after each regime

    To assess the effect of LIPA on plasma free fatty acids

  10. Plasma apolipoprotein B

    Time frame: one day after each regime

    To assess the effect of LIPA on plasma apolipoprotein B

  11. Plasma apolipoprotein A

    Time frame: one day after each regime

    To assess the effect of LIPA on plasma apolipoprotein A

  12. Mood (measured by the Affect Grid mood scale)

    Time frame: 2 days: last day of each regime and one day after each regime

    To assess the effect of LIPA on mood

  13. Attention (measured by the Attention Network Task)

    Time frame: one day after each regime before and after the oral glucose tolerance test

    To assess the effect of LIPA on attention

  14. Executive Function (measured by the Trail Making Test)

    Time frame: one day after each regime before and after the oral glucose tolerance test

    To assess the effect of LIPA on executive function

  15. Memory (measured by the Rey Auditory Verbal Learning Task)

    Time frame: one day after each regime before and after the oral glucose tolerance test

    To assess the effect of LIPA on memory

  16. Quality of life (measured by the Gill 32-item questionnaire)

    Time frame: last day of each regime

    To assess the effect of LIPA on quality of life

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

    Time frame: last day of each regime

    To assess the effect of LIPA on sleep

  18. Plasma C-reactive protein

    Time frame: one day after each regime

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

  19. Plasma interleukin 1

    Time frame: one day after each regime

    To assess the effect of LIPA on plasma interleukin 1

  20. Plasma interleukin 6

    Time frame: one day after each regime

    To assess the effect of LIPA on plasma interleukin 6

  21. Plasma TNF-alpha

    Time frame: one day after each regime

    To assess the effect of LIPA on plasma TNF-alpha

  22. Plasma interferon gamma

    Time frame: one day after each regime

    To assess the effect of LIPA on plasma interferon gamma

  23. Plasma ICAM-1

    Time frame: one day after each regime

    To assess the effect of LIPA on plasma ICAM-1

  24. Plasma VCAM

    Time frame: one day after each regime

    To assess the effect of LIPA on plasma VCAM

  25. Plasma serum amyloid A (SAA)

    Time frame: one day after each regime

    To assess the effect of LIPA on plasma SAA

  26. Plasma E-selectine

    Time frame: one day after each regime

    To assess the effect of LIPA on plasma E-selectine

  27. Plasma von Willebrand factor (vWF)

    Time frame: one day after each regime

    To assess the effect of LIPA on plasma vWF

  28. Plasma PAI-1

    Time frame: one day after each regime

    To assess the effect of LIPA on plasma PAI-1

  29. 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

  30. Blood pressure

    Time frame: one day after each regime

  31. Heart rate

    Time frame: one day after each regime

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Unilever R&D

Registry information

Acronym: SIT LESS 3

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 20, 2015
Registry last updated
Mar 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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