The Effect of Colchicine on Food-related Effort-based Decision Making in Brain and Behaviour in Overweight and Obesity

Prior treatment

• Having been vaccinated by any type of vaccine in the 4 weeks preceding the first test session
• 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

Other illness

• 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
• 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, blindness or colour-blindness, as judged by the investigator
• Current or history of alcohol and/or drugs abuse (i.e. \>14 units per week)

Lab values

• Have renal impairment as evidenced by serum creatinine \>150 μmol/l or eGFR \<50mL/min/1.73m2, determined maximum 12 weeks before inclusion

Other

• Gained or lost \>2 points in BMI (kg/m2) over the last 6 months
• Followed an energy restricting diet during the last 2 months
• Habitual smoking, i.e. one or more cigarettes per day
• Pregnant, lactating or wishing to become pregnant in the period between the screening and until 3 months after the last study visit
• Participation in another weight loss, lifestyle or anti-inflammatory intervention in the context of research at the time of inclusion or during the study
• Contraindications for MRI

• 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