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

Primary Purpose

Overweight, Obesity

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Physical activity regime
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight focused on measuring Insulin Resistance, Cognition, Affect, Insulin, Lipids

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Human Movement Science, Maastricht University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Sitting regime

Sit Less regime

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
February 19, 2015
Last Updated
March 15, 2016
Sponsor
Maastricht University Medical Center
Collaborators
Unilever R&D
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1. Study Identification

Unique Protocol Identification Number
NCT02394249
Brief Title
SIT LESS 3: The Effect of Low Intensity Physical Activity on Insulin Sensitivity, Mood and Cognitive Performance
Acronym
SIT LESS 3
Official Title
SIT LESS 3: The Effect of Low Intensity Physical Activity on Insulin Sensitivity, Mood and Cognitive Performance
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
Collaborators
Unilever R&D

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
Insulin Resistance, Cognition, Affect, Insulin, Lipids

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sitting regime
Arm Type
Experimental
Arm Description
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.
Arm Title
Sit Less regime
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Physical activity regime
Intervention Description
Information already included in arm descriptions
Primary Outcome Measure Information:
Title
Plasma insulin levels (measured as area under the curve during an oral glucose tolerance test)
Description
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 Outcome Measure Information:
Title
Insulin sensitivity (measured as Matsuda combined insulin sensitivity index during an oral glucose tolerance test)
Description
To assess the effect of LIPA on insulin sensitivity
Time Frame
one day after each regime
Title
Plasma C-peptide
Description
To assess the effect of LIPA on plasma C-peptide
Time Frame
one day after each regime
Title
Plasma glucose levels
Description
To assess the effect of LIPA on plasma glucose levels
Time Frame
one day after each regime
Title
Plasma triglycerides
Description
To assess the effect of LIPA on plasma triglycerides
Time Frame
one day after each regime
Title
Plasma total cholesterol
Description
To assess the effect of LIPA on plasma total cholesterol
Time Frame
one day after each regime
Title
Plasma non-HDL cholesterol
Description
To assess the effect of LIPA on plasma non-HDL cholesterol
Time Frame
one day after each regime
Title
Plasma HDL cholesterol
Description
To assess the effect of LIPA on plasma HDL cholesterol
Time Frame
one day after each regime
Title
Plasma LDL cholesterol
Description
To assess the effect of LIPA on plasma LDL cholesterol
Time Frame
one day after each regime
Title
Plasma free fatty acids
Description
To assess the effect of LIPA on plasma free fatty acids
Time Frame
one day after each regime
Title
Plasma apolipoprotein B
Description
To assess the effect of LIPA on plasma apolipoprotein B
Time Frame
one day after each regime
Title
Plasma apolipoprotein A
Description
To assess the effect of LIPA on plasma apolipoprotein A
Time Frame
one day after each regime
Title
Mood (measured by the Affect Grid mood scale)
Description
To assess the effect of LIPA on mood
Time Frame
2 days: last day of each regime and one day after each regime
Title
Attention (measured by the Attention Network Task)
Description
To assess the effect of LIPA on attention
Time Frame
one day after each regime before and after the oral glucose tolerance test
Title
Executive Function (measured by the Trail Making Test)
Description
To assess the effect of LIPA on executive function
Time Frame
one day after each regime before and after the oral glucose tolerance test
Title
Memory (measured by the Rey Auditory Verbal Learning Task)
Description
To assess the effect of LIPA on memory
Time Frame
one day after each regime before and after the oral glucose tolerance test
Title
Quality of life (measured by the Gill 32-item questionnaire)
Description
To assess the effect of LIPA on quality of life
Time Frame
last day of each regime
Title
Sleep (measured by the 10-item Pittsburgh Sleep Quality Index)
Description
To assess the effect of LIPA on sleep
Time Frame
last day of each regime
Title
Plasma C-reactive protein
Description
To assess the effect of LIPA on plasma C-reactive protein
Time Frame
one day after each regime
Title
Plasma interleukin 1
Description
To assess the effect of LIPA on plasma interleukin 1
Time Frame
one day after each regime
Title
Plasma interleukin 6
Description
To assess the effect of LIPA on plasma interleukin 6
Time Frame
one day after each regime
Title
Plasma TNF-alpha
Description
To assess the effect of LIPA on plasma TNF-alpha
Time Frame
one day after each regime
Title
Plasma interferon gamma
Description
To assess the effect of LIPA on plasma interferon gamma
Time Frame
one day after each regime
Title
Plasma ICAM-1
Description
To assess the effect of LIPA on plasma ICAM-1
Time Frame
one day after each regime
Title
Plasma VCAM
Description
To assess the effect of LIPA on plasma VCAM
Time Frame
one day after each regime
Title
Plasma serum amyloid A (SAA)
Description
To assess the effect of LIPA on plasma SAA
Time Frame
one day after each regime
Title
Plasma E-selectine
Description
To assess the effect of LIPA on plasma E-selectine
Time Frame
one day after each regime
Title
Plasma von Willebrand factor (vWF)
Description
To assess the effect of LIPA on plasma vWF
Time Frame
one day after each regime
Title
Plasma PAI-1
Description
To assess the effect of LIPA on plasma PAI-1
Time Frame
one day after each regime
Title
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
Title
Blood pressure
Time Frame
one day after each regime
Title
Heart rate
Time Frame
one day after each regime

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans H Savelberg, PhD
Organizational Affiliation
Maastricht University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Human Movement Science, Maastricht University
City
Maastricht
ZIP/Postal Code
6200MD
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
23418444
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. Erratum In: PLoS One. 2014;9(8):e105135.
Results Reference
background
Links:
URL
http://www.plosone.org/article/metrics/info%3Adoi%2F10.1371%2Fjournal.pone.0055542
Description
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SIT LESS 3: The Effect of Low Intensity Physical Activity on Insulin Sensitivity, Mood and Cognitive Performance

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