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

Obesity Clinical Trial

— SIT LESS 3  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02394249
• Other study ID #: 143046
• Secondary ID: NL50688.068.14
• Status: Completed
• Phase: N/A
• First received: February 19, 2015
• Last updated: March 15, 2016
• Start date: February 2015
• Est. completion date: September 2015

Study information

• Verified date: March 2016
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical 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). 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Behavioral:
• Physical activity regime
Information already included in arm descriptions

Locations

Country	Name	City	State
Netherlands	Human Movement Science, Maastricht University	Maastricht

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Unilever R&D

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	one day after each regime	No
Secondary	Insulin sensitivity (measured as Matsuda combined insulin sensitivity index during an oral glucose tolerance test)	To assess the effect of LIPA on insulin sensitivity	one day after each regime	No
Secondary	Plasma C-peptide	To assess the effect of LIPA on plasma C-peptide	one day after each regime	No
Secondary	Plasma glucose levels	To assess the effect of LIPA on plasma glucose levels	one day after each regime	No
Secondary	Plasma triglycerides	To assess the effect of LIPA on plasma triglycerides	one day after each regime	No
Secondary	Plasma total cholesterol	To assess the effect of LIPA on plasma total cholesterol	one day after each regime	No
Secondary	Plasma non-HDL cholesterol	To assess the effect of LIPA on plasma non-HDL cholesterol	one day after each regime	No
Secondary	Plasma HDL cholesterol	To assess the effect of LIPA on plasma HDL cholesterol	one day after each regime	No
Secondary	Plasma LDL cholesterol	To assess the effect of LIPA on plasma LDL cholesterol	one day after each regime	No
Secondary	Plasma free fatty acids	To assess the effect of LIPA on plasma free fatty acids	one day after each regime	No
Secondary	Plasma apolipoprotein B	To assess the effect of LIPA on plasma apolipoprotein B	one day after each regime	No
Secondary	Plasma apolipoprotein A	To assess the effect of LIPA on plasma apolipoprotein A	one day after each regime	No
Secondary	Mood (measured by the Affect Grid mood scale)	To assess the effect of LIPA on mood	2 days: last day of each regime and one day after each regime	No
Secondary	Attention (measured by the Attention Network Task)	To assess the effect of LIPA on attention	one day after each regime before and after the oral glucose tolerance test	No
Secondary	Executive Function (measured by the Trail Making Test)	To assess the effect of LIPA on executive function	one day after each regime before and after the oral glucose tolerance test	No
Secondary	Memory (measured by the Rey Auditory Verbal Learning Task)	To assess the effect of LIPA on memory	one day after each regime before and after the oral glucose tolerance test	No
Secondary	Quality of life (measured by the Gill 32-item questionnaire)	To assess the effect of LIPA on quality of life	last day of each regime	No
Secondary	Sleep (measured by the 10-item Pittsburgh Sleep Quality Index)	To assess the effect of LIPA on sleep	last day of each regime	No
Secondary	Plasma C-reactive protein	To assess the effect of LIPA on plasma C-reactive protein	one day after each regime	No
Secondary	Plasma interleukin 1	To assess the effect of LIPA on plasma interleukin 1	one day after each regime	No
Secondary	Plasma interleukin 6	To assess the effect of LIPA on plasma interleukin 6	one day after each regime	No
Secondary	Plasma TNF-alpha	To assess the effect of LIPA on plasma TNF-alpha	one day after each regime	No
Secondary	Plasma interferon gamma	To assess the effect of LIPA on plasma interferon gamma	one day after each regime	No
Secondary	Plasma ICAM-1	To assess the effect of LIPA on plasma ICAM-1	one day after each regime	No
Secondary	Plasma VCAM	To assess the effect of LIPA on plasma VCAM	one day after each regime	No
Secondary	Plasma serum amyloid A (SAA)	To assess the effect of LIPA on plasma SAA	one day after each regime	No
Secondary	Plasma E-selectine	To assess the effect of LIPA on plasma E-selectine	one day after each regime	No
Secondary	Plasma von Willebrand factor (vWF)	To assess the effect of LIPA on plasma vWF	one day after each regime	No
Secondary	Plasma PAI-1	To assess the effect of LIPA on plasma PAI-1	one day after each regime	No
Secondary	To explore the association between plasma glucose, plasma insulin, insulin sensitivity and mood, cognitive performance, quality of life and sleep		one day after each regime	No
Secondary	Blood pressure		one day after each regime	No
Secondary	Heart rate		one day after each regime	No

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