The Effect of Colchicine on Food-related Effort-based Decision Making in Brain and Behaviour in Overweight and Obesity (FLAIR-i)
Overweight and Obesity
About this trial
This is an interventional other trial for Overweight and Obesity focused on measuring Overweight, Obesity, Inflammation, fMRI, Motivation
Eligibility Criteria
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, blindness or colour-blindness, as judged by the investigator Current or history of alcohol and/or drugs abuse (i.e. >14 units per week) 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
Sites / Locations
- Donders Centre for Cognitive NeuroimagingRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Colchicine
Placebo
One tablet of colchicine 0.5 mg per day
One tablet of microcrystalline cellulose per day