OverweightSIT LESS 3NCT02394249
SIT LESS 3: The Effect of Low Intensity Physical Activity on Insulin Sensitivity, Mood and Cognitive Performance
A study testing Physical activity regime in people with Overweight and Obesity, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Physical activity regime
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2015to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Human Movement Science, Maastricht University
Maastricht, Maastricht, 6200MD
About this study
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.
Read more
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
- Conditions
- Overweight, Obesity
- Being tested
- Physical activity regime
- Keywords
- Insulin Resistance, Cognition, Affect, Insulin, Lipids
- Medical subject headings
- Overweight, Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity regimeBehavioural
Information already included in arm descriptions
| Study group | Role | What they receive |
|---|---|---|
| Sitting regime | Experimental | 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. Receives: Behavioral: Physical activity regime |
| Sit Less regime | Experimental | 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. Receives: Behavioral: Physical activity regime |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: one day after each regime
Secondary outcomes (31)
Insulin sensitivity (measured as Matsuda combined insulin sensitivity index during an oral glucose tolerance test)
To assess the effect of LIPA on insulin sensitivity
Measured: one day after each regime
Plasma C-peptide
To assess the effect of LIPA on plasma C-peptide
Measured: one day after each regime
Plasma glucose levels
To assess the effect of LIPA on plasma glucose levels
Measured: one day after each regime
Plasma triglycerides
To assess the effect of LIPA on plasma triglycerides
Measured: one day after each regime
Plasma total cholesterol
To assess the effect of LIPA on plasma total cholesterol
Measured: one day after each regime
Plasma non-HDL cholesterol
To assess the effect of LIPA on plasma non-HDL cholesterol
Measured: one day after each regime
Plasma HDL cholesterol
To assess the effect of LIPA on plasma HDL cholesterol
Measured: one day after each regime
Plasma LDL cholesterol
To assess the effect of LIPA on plasma LDL cholesterol
Measured: one day after each regime
Plasma free fatty acids
To assess the effect of LIPA on plasma free fatty acids
Measured: one day after each regime
Plasma apolipoprotein B
To assess the effect of LIPA on plasma apolipoprotein B
Measured: one day after each regime
Plasma apolipoprotein A
To assess the effect of LIPA on plasma apolipoprotein A
Measured: one day after each regime
Mood (measured by the Affect Grid mood scale)
To assess the effect of LIPA on mood
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: last day of each regime
Sleep (measured by the 10-item Pittsburgh Sleep Quality Index)
To assess the effect of LIPA on sleep
Measured: last day of each regime
Plasma C-reactive protein
To assess the effect of LIPA on plasma C-reactive protein
Measured: one day after each regime
Plasma interleukin 1
To assess the effect of LIPA on plasma interleukin 1
Measured: one day after each regime
Plasma interleukin 6
To assess the effect of LIPA on plasma interleukin 6
Measured: one day after each regime
Plasma TNF-alpha
To assess the effect of LIPA on plasma TNF-alpha
Measured: one day after each regime
Plasma interferon gamma
To assess the effect of LIPA on plasma interferon gamma
Measured: one day after each regime
Plasma ICAM-1
To assess the effect of LIPA on plasma ICAM-1
Measured: one day after each regime
Plasma VCAM
To assess the effect of LIPA on plasma VCAM
Measured: one day after each regime
Plasma serum amyloid A (SAA)
To assess the effect of LIPA on plasma SAA
Measured: one day after each regime
Plasma E-selectine
To assess the effect of LIPA on plasma E-selectine
Measured: one day after each regime
Plasma von Willebrand factor (vWF)
To assess the effect of LIPA on plasma vWF
Measured: one day after each regime
Plasma PAI-1
To assess the effect of LIPA on plasma PAI-1
Measured: 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
Measured: one day after each regime
Blood pressure
Measured: one day after each regime
Heart rate
Measured: one day after each regime
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Unilever R&D
- Responsible party
- Sponsor
- Investigators
- Hans H Savelberg, PhD, Principal investigator, Maastricht University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02394249
- Sponsor's protocol ID
- 143046
- Other IDs
- NL50688.068.14
- Acronym
- SIT LESS 3
- Status last verified
- Mar 2016
- First submitted
- 19 Feb 2015
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23418444
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SIT LESS 3: The Effect of Low Intensity Physical Activity on Insulin Sensitivity, Mood and Cognitive Performance
- ClinicalTrials.gov ID
- NCT02394249
- Acronym / sponsor ID
- SIT LESS 3 / 143046
- Conditions
- Overweight, Obesity
- Keywords
- Insulin Resistance, Cognition, Affect, Insulin, Lipids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Unilever R&D
- Study start
- Feb 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 20 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sitting regime | Experimental | Behavioral: Physical activity regimeThe 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. |
| Sit Less regime | Experimental | Behavioral: Physical activity regimeSubjects 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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity regimeInformation already included in arm descriptions | Behavioural | Sit Less regime, Sitting regime |
Primary outcome
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)
31 secondary outcomes
Insulin sensitivity (measured as Matsuda combined insulin sensitivity index during an oral glucose tolerance test)
Time frame: one day after each regime
Plasma C-peptide
Time frame: one day after each regime
Plasma glucose levels
Time frame: one day after each regime
Plasma triglycerides
Time frame: one day after each regime
Plasma total cholesterol
Time frame: one day after each regime
Plasma non-HDL cholesterol
Time frame: one day after each regime
Plasma HDL cholesterol
Time frame: one day after each regime
Plasma LDL cholesterol
Time frame: one day after each regime
Plasma free fatty acids
Time frame: one day after each regime
Plasma apolipoprotein B
Time frame: one day after each regime
Plasma apolipoprotein A
Time frame: one day after each regime
Mood (measured by the Affect Grid mood scale)
Time frame: 2 days: last day of each regime and one day after each regime
Attention (measured by the Attention Network Task)
Time frame: one day after each regime before and after the oral glucose tolerance test
Executive Function (measured by the Trail Making Test)
Time frame: one day after each regime before and after the oral glucose tolerance test
Memory (measured by the Rey Auditory Verbal Learning Task)
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)
Time frame: last day of each regime
Sleep (measured by the 10-item Pittsburgh Sleep Quality Index)
Time frame: last day of each regime
Plasma C-reactive protein
Time frame: one day after each regime
Plasma interleukin 1
Time frame: one day after each regime
Plasma interleukin 6
Time frame: one day after each regime
Plasma TNF-alpha
Time frame: one day after each regime
Plasma interferon gamma
Time frame: one day after each regime
Plasma ICAM-1
Time frame: one day after each regime
Plasma VCAM
Time frame: one day after each regime
Plasma serum amyloid A (SAA)
Time frame: one day after each regime
Plasma E-selectine
Time frame: one day after each regime
Plasma von Willebrand factor (vWF)
Time frame: one day after each regime
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
- Background: PubMed 23418444Duvivier 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans H Savelberg, PhD principal investigator
Maastricht University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity regime in people with Overweight and Obesity, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma insulin levels (measured as area under the curve during an oral glucose tolerance test) (time frame: one day after each regime). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02394249, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2016.