The main objective of the FLAIR-i study is to study the causal role of inflammation in affecting effort-based decision making in brain and behaviour in overweight and obesity, by comparing the effect of the anti-inflammatory agent colchicine vs. placebo.
Obesity is a major health problem worldwide and is characterized by increases in low-grade, systemic inflammation. Outside the field of obesity, increases in inflammation have been related to loss of motivation and effortful behaviour, which can be objectively measured with effort-based decision making in brain and behaviour. Here, the investigators hypothesise that low-grade inflammation is causing altered striatal brain responses and effortless 'fast food' choices in overweight and obesity. The objective of this study is to study the causal role of inflammation in affecting effort-based decision making in brain and behaviour in overweight and obese participants, by comparing the effect of the anti-inflammatory agent colchicine vs. placebo. In addition, it will be investigated whether this primary objective translates to more ecologically valid measures/settings.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
59
Participant in the intervention group receive one tablet of 0.5mg colchicine per day for 12 weeks.
Participants in the intervention group receive one tablet of placebo per day for 12 weeks.
Donders Centre for Cognitive Neuroimaging
Nijmegen, Netherlands
Change in effort valuation in brain and behaviour
Brain activity (BOLD signal during functional MRI) and behavioural weightings upon/of effort sensitivity, as measured by an effort-based decision making task.
Time frame: Change between baseline and follow-up after 12 weeks
Change in reward valuation in brain and behaviour
Brain activity (BOLD signal during functional MRI) and behavioural weightings upon/of reward sensitivity, as measured by an effort-based decision making task.
Time frame: Change between baseline and follow-up after 12 weeks
Change effort/reward related food intake ratio
Intake of food items varying in effort and reward/calories, measured by a bogus food taste test.
Time frame: Change between baseline and follow-up after 12 weeks
Change in reward anticipation/reward consummation ratio in daily life
Reward anticipation and reward consummation scores in daily life as measured by the Experience Sampling Method
Time frame: Change between baseline and follow-up after 12 weeks
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