The Effect of Colchicine on Food-related Effort-based Decision Making in Brain and Behaviour in O… (NCT05785429) | Clinical Trial Compass
CompletedNot Applicable
The Effect of Colchicine on Food-related Effort-based Decision Making in Brain and Behaviour in Overweight and Obesity
Netherlands59 participantsStarted 2022-08-02
Plain-language summary
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.
Who can participate
Age range18 Years – 59 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* BMI ≥ 27 kg/m2
* Female sex
* Right-handed
* Age: 18-59 years
* Shoulder width of \< 68 cm (to fit into the MRI scanner)
* Dutch speaking - Sufficient level to understand task instructions
* Low-grade inflammatory state, as measured by C-reactive protein (CRP) between 3.0 and 10.0 mg/L
Exclusion Criteria:
* Having been vaccinated by any type of vaccine in the 4 weeks preceding the first test session
* Having had an infection characterized by a fever, or diagnosed by a medical physician in the 4 weeks preceding the first test session
* Diagnosed with Diabetes Mellitus type I or II
* Gained or lost \>2 points in BMI (kg/m2) over the last 6 months
* Followed an energy restricting diet during the last 2 months
* Having had bariatric surgery in the past 5 years
* Regular use of anti-inflammatory, anti-diabetic, weight-loss, and psychoactive medication
* Regular use of CYP3A4 inhibitors, P-glycoprotein inhibitors, statins, fibrates, ciclosporin, and digoxin, as a contraindication for colchicine
* Have renal impairment as evidenced by serum creatinine \>150 μmol/l or eGFR \<50mL/min/1.73m2, determined maximum 12 weeks before inclusion
* Have moderate to severe hepatic disease
* (History of) clinically significant psychiatric or neurological disorder
* (History of) clinically significant metabolic, cardiovascular, renal, liver, endocrinological, autoimmune or chronic inflammatory disease
* General medical conditions, such as sensorimotor handicaps, deafness, …
What they're measuring
1
Change in effort valuation in brain and behaviour
Timeframe: Change between baseline and follow-up after 12 weeks
2
Change in reward valuation in brain and behaviour
Timeframe: Change between baseline and follow-up after 12 weeks