An interventional study of Colchicine 0.5 MG and Placebo in Overweight and Obesity, sponsored by Donders Centre for Cognitive Neuroimaging. Completed at 1 site in Netherlands. Open to female participants aged 18 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-02.
Sponsored by Donders Centre for Cognitive Neuroimaging · Not applicable, Interventional, and Other
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.
3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.
This study's enrollment of 59 is below the median of 73 across 3,175 interventional studies indexed under Overweight.
Browse Overweight studies →Donders Centre for Cognitive Neuroimaging is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
One tablet of colchicine 0.5 mg per day
Drug: Colchicine 0.5 MG
One tablet of microcrystalline cellulose per day
Drug: Placebo
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.
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
C-reactive protein
High sensitive C-reactive protein measured in plasma
Time frame: Change between baseline and follow-up after 12 weeks
Inflammation profile (blood)
Assay-based profile of systemic inflammation measured in plasma stimulation, Olink Inflammatory profile
Time frame: Change between baseline and follow-up after 12 weeks
Brain myo-inositol levels
Brain myo-inositol levels reflecting neuroinflammation in ventral striatum and ACC, measured by magnetic resonance spectroscopy
Time frame: Change between baseline and follow-up after 12 weeks
Abdominal fat distribution
VAT(visceral adipose tissue)/SAT(subcutaneous adipose tissue) ratio based on abdominal MRI scan
Time frame: Change between baseline and follow-up after 12 weeks
(Resting state) functional connectivity networks
Measured by functional MRI
Time frame: Change between baseline and follow-up after 12 weeks
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Donders Centre for Cognitive Neuroimaging